Sensory environment on health‐related outcomes of hospital patients

Amy Drahota; Derek Ward; Heather Mackenzie; Rebecca Stores; Bernie Higgins; Diane Gal; Taraneh P Dean

doi:10.1002/14651858.CD005315.pub2

. 2012 Mar 14;2012(3):CD005315. doi: 10.1002/14651858.CD005315.pub2

Sensory environment on health‐related outcomes of hospital patients

Amy Drahota ^1,^✉, Derek Ward ², Heather Mackenzie ², Rebecca Stores ², Bernie Higgins ³, Diane Gal ⁴, Taraneh P Dean ²

Editor: Cochrane Effective Practice and Organisation of Care Group

PMCID: PMC6464891 PMID: 22419308

Abstract

Background

Hospital environments have recently received renewed interest, with considerable investments into building and renovating healthcare estates. Understanding the effectiveness of environmental interventions is important for resource utilisation and providing quality care.

Objectives

To assess the effect of hospital environments on adult patient health‐related outcomes.

Search methods

We searched: the Cochrane Central Register of Controlled Trials (last searched January 2006); MEDLINE (1902 to December 2006); EMBASE (January 1980 to February 2006); 14 other databases covering health, psychology, and the built environment; reference lists; and organisation websites. This review is currently being updated (MEDLINE last search October 2010), see Studies awaiting classification.

Selection criteria

Randomised and non‐randomised controlled trials, controlled before‐and‐after studies, and interrupted times series of environmental interventions in adult hospital patients reporting health‐related outcomes.

Data collection and analysis

Two review authors independently undertook data extraction and 'Risk of bias' assessment. We contacted authors to obtain missing information. For continuous variables, we calculated a mean difference (MD) or standardized mean difference (SMD), and 95% confidence intervals (CI) for each study. For dichotomous variables, we calculated a risk ratio (RR) with 95% confidence intervals (95% CI). When appropriate, we used a random‐effects model of meta‐analysis. Heterogeneity was explored qualitatively and quantitatively based on risk of bias, case mix, hospital visit characteristics, and country of study.

Main results

Overall, 102 studies have been included in this review. Interventions explored were: 'positive distracters', to include aromas (two studies), audiovisual distractions (five studies), decoration (one study), and music (85 studies); interventions to reduce environmental stressors through physical changes, to include air quality (three studies), bedroom type (one study), flooring (two studies), furniture and furnishings (one study), lighting (one study), and temperature (one study); and multifaceted interventions (two studies). We did not find any studies meeting the inclusion criteria to evaluate: art, access to nature for example, through hospital gardens, atriums, flowers, and plants, ceilings, interventions to reduce hospital noise, patient controls, technologies, way‐finding aids, or the provision of windows. Overall, it appears that music may improve patient‐reported outcomes such as anxiety; however, the benefit for physiological outcomes, and medication consumption has less support. There are few studies to support or refute the implementation of physical changes, and except for air quality, the included studies demonstrated that physical changes to the hospital environment at least did no harm.

Authors' conclusions

Music may improve patient‐reported outcomes in certain circumstances, so support for this relatively inexpensive intervention may be justified. For some environmental interventions, well designed research studies have yet to take place.

Keywords: Adult; Humans; Health Facility Environment; Interior Design and Furnishings; Outcome and Process Assessment, Health Care; Air Pollution, Indoor; Inpatients; Inpatients/psychology; Lighting; Music; Music/psychology; Odorants; Randomized Controlled Trials as Topic; Temperature

Plain language summary

Sensory environment on health‐related outcomes of hospital patients

The hospital environment (such as sounds, pictures, aromas, design, air quality, furnishings, architecture, and layout), may have an impact on the health of patients within it. This review aims to summarise the best available evidence on hospital environments, in order to help people involved in the design of hospital environments make decisions that will benefit patients' health.

The review identified 102 relevant studies, 85 of which were on the use of music in hospital. Other environmental aspects considered were: aromas (two studies), audiovisual distractions (five studies), decoration (one study), air quality (three studies), bedroom type (one study), flooring (two studies), furniture and furnishings (one study), lighting (one study), temperature (one study), and multiple design changes (two studies). No studies meeting the inclusion criteria were found to evaluate: art, access to nature for example through hospital gardens, atriums, flowers, and plants, ceilings, interventions to reduce hospital noise, patient controls, technologies, way‐finding aids, or the provision of windows.

Overall, it appears that music in hospital may help improve patient‐reported outcomes such as anxiety; however, there is less evidence to support the use of music for physiological outcomes (such as reducing heart rate and blood pressure) and for reducing the use of medications. For other aspects of hospital environments, there are not very many well designed studies to help with making evidence‐based design decisions. The studies that have been included in this review show that physical changes made to 'improve' the hospital environment on the whole do no harm.

Background

The International Academy for Design and Health held its 7th World Congress in 2011, highlighting the growing multinational interest in environmental design that promotes health. A reform on a global scale is underway to make hospitals much more than places to go and receive treatment; hospitals are now being conceptualised as places that have the potential to positively impact health through being restorative, healing environments (Dilani 2001). The World Health Organization (WHO) highlights the important role of the environment in the health process, and calls for action towards creating supportive environments ('Ottowa' 2004). In accordance with this movement, international organisations such as The Centre for Health Design (CHD) have been established ('CHD' 2009). CHD's mission is 'to transform healthcare environments for a healthier, safer world through design research, education and advocacy'.

Other initiatives have been stimulated by the US‐based Society for the Arts in Healthcare ('SAH' 2009), which attempts to advance arts as an integral component in health care, and the UK‐based Medical Architecture Research Unit (Etheridge 2008), which provides research, consultancy, and training, with a vision to "explore the interface between health service organisational culture and the built environment response". Research into, and implementation of 'healing' healthcare environments is also being carried out in Japan (Cooper 2002; Takayanagi 2004), and across Europe (Pelikan 2001).

In the Middle East, various major investment projects have been supporting a rapid growth in the hospital sector (News 2004) and the hospital industry in the United States has been going through a major building boom with billions more dollars being spent on replacing or renovating old facilities (Babwin 2002). In the United Kingdom, the Private Finance Initiative (PFI) has prompted a renewed interest in hospital design, investing billions of pounds into the biggest new hospital building programme in the history of the NHS (Milburn 2001). Investments such as these have provided an opportunity for hospitals to be considered as 'therapeutic environments' (Gesler 2004), spurring on initiatives such as the UK‐based scheme in which the Kings Fund and the Department of Health offer grants to health authorities to enhance the environment ('Kings Fund' 2009).

Some argue that this expenditure is a waste of resources (Lipley 2001), whilst others have highlighted the lack of 'evidence‐based practice' when it comes to hospital design (Frumkin 2003). Schemes set up to enhance the hospital environment are sometimes not evaluated on the grounds that it is too logistically complex (Comer 1982), or by simply stating that the effects are obvious (Parker 2000). There is some empirical evidence in support of creating better environments in care facilities however, and researchers are finding that changes to the physical environment can positively influence patient outcomes (Devlin 2003; Rubin 1996). In an invitation‐only conference entitled 'Designing the 21st Century Hospital: serving patients and staff', held by the Robert Wood Johnson Foundation ('Webcast' 2004), Craig Zimring and Roger Ulrich referred to a literature review they had conducted, finding over 600 studies on the effects of the hospital environment on patients, families and staff (Ulrich 2004a, later updated: Ulrich 2008). In their presentation of the research, Zimring and Ulrich emphasised the evidence mainly in terms of quantity and consistency of findings. Following the presentations, delegates discussed how worthwhile applying quality criteria to the current evidence would be, such as in a Cochrane systematic review.

Description of the intervention

The environment can be altered in endless ways. Some environmental changes may be detrimental to health (Thompson 2000), further exemplifying the need for using evidence‐based design. As a framework for assessing the evidence on hospital design, the literature could be considered in terms of whether it regards: (1) aspects that are added to the environment as positive distracters (such as art and music); and (2) aspects of the environment that are changed to reduce stressors (such as light, noise or air quality).

In this review, we are interested in elements of the sensory environment; that is, aspects of the hospital surroundings that can be seen, touched, smelt, or heard (such as the building design and layout, decor, furniture and furnishings, air quality and aromas/odours, and noises/sounds). In this review we utilise the phrase 'sensory environment' to define the hospital characteristics under study; in the literature, other terms are utilised such as 'healing environments', 'supportive environments', and 'health‐promoting environments'. We have opted for a less directive phrase as we are interested in determining which environmental factors have positive, negative, and neutral effects on the health of individuals.

How the intervention might work

Sensory environments have been advocated on the basis of their perceived ability to reduce anxiety, lower blood pressure, improve postoperative outcomes, reduce the need for pain medication, and shorten the hospital stay (Ulrich 1992); good design has also been implicated to improve quality of sleep (Hewitt 2002; Marberry 2002), reduce hospital acquired infections (Ulrich 2004b), and improve staff retention and well‐being (Neuberger 2003; Marberry 2002; Gross 1998). Theories underpinning these effects are wide‐ranging and stem from a variety of perspectives, for example: Attention Restorative Theory (a 'functionalist‐evolutionary' model; Kaplan 1989); a 'psycho‐evolutionary' model (Ulrich 1983) and the Biophilia Hypothesis (Ulrich 1993a); Henry's model of neuro‐endocrine responses (Parsons 1991, which incorporates the ideas of the 'Fight or Flight' response to environmental stressors and Selye's model of stress and disease, 'General Adaptation Syndrome'); the Intake‐Reject Hypothesis (Lacey 1974), a controversial hypothesis which has implications for distraction therapies; the 'Gate Control Theory' (Melzack 1965) and the 'Neuromatrix Theory' of pain (Melzack 1999); and the Broaden‐and‐Build model (Fredrickson 2000), which offers a premise for creating environments which help cultivate positive emotions. We will not go into a full explanation and debate of all these theories here, but suffice is to say that although there are some disparities between these explanatory models, and some sit controversially within their fields, they complement each other on the general principles that removing environmental stressors, and using the environment to calm, distract, and elicit positive emotions may have positive implications for health.

Why it is important to do this review

Clearly this is a broad and complex area of study, with the 'environment' being considered as an intervention influencing health‐related outcomes; nevertheless, it is imperative that the evidence‐base for sensory environments is assessed systematically, to ensure that patients are provided with the best possible opportunity to recover and that the system remains cost‐effective.

Objectives

To assess the effect of the sensory hospital environment on adult patient health‐related outcomes.

Methods

Criteria for considering studies for this review

Types of studies

In this area of research it may often be very difficult to conduct a Randomised Controlled Trial (RCT) due to the nature of the intervention and logistical complexities. Therefore, this review included a variety of study designs: RCTs, (non‐randomised) Controlled Clinical Trials (CCTs), Controlled Before and After studies (CBAs), and Interrupted Time Series (ITS). To be included in the review, a CBA had to have two intervention sites and two concurrent control sites with outcomes measured both before and after the intervention was implemented. An ITS had to have at least three data collection points before the intervention, and at least a further three data collection points after the intervention. All studies must have been conducted prospectively.

Types of participants

The review included adults attending hospital as in‐patients, day hospital or out‐patients. Studies were included if over 90% of the participants were over 18. Both elective and non‐elective patients were included in the review. We have included all diagnoses including psychiatric patients (Gross 1998).

Where possible, studies were characterised by the type of hospital visit, where 90% of participants was considered as a cut‐off point for inclusion in a specific category. In‐patients were classed as those that required a hospital bed and required an overnight stay for tests or surgery; day‐patients were patients that required a hospital bed for specialised observation or health care for a limited number of hours of the day, but did not need to stay overnight; out‐patients were people who were referred to see a hospital consultant for a specialist opinion or examination and did not require a hospital bed.

Types of interventions

The review incorporated studies that investigated any aspect(s) of the sensory environment. Interventions were those that altered the environment by one or a mixture of the following ways.

(1) Providing positive distracters to complement the treatment already being administered. Positive distracters are elements of the sensory environment; they do not include therapies (such as bright light therapy), which are received instead of orthodox treatments. Patients could be offered a choice of distraction but we did not include instances when patients were actively involved in creating a distraction (e.g. creating a work of art). Positive distracters included:

aromas/scents (different aromas/patient choice of aroma versus none);
viewing artwork (comparing different styles/patient choice of art versus no art);
viewing performance art (versus none);
audiovisual distractions, such as television/video (absent versus present/differences between content/patient choice of content);
decoration (colour of walls etc.);
music (versus no music, different styles of music, or other environmental comparison);
access to nature, for example via atriums, gardens, window views, or indoor planting (versus no access to nature, other views or urban retreats).

(2) Reducing environmental stressors by implementing physical changes. We have not included changes that are made to policy (e.g. ensuring multi‐bed rooms are unisex). Physical changes to the sensory environment include:

noise‐reducing aids (e.g. sound‐absorbing ceiling tiles versus regular);
way‐finding aids (e.g. colour‐zoned areas, landmarks);
patient controls (e.g. access to lighting and ventilation controls);
lighting (e.g. natural versus fluorescent);
people/privacy (e.g. open versus closed wards, decentralised nurse stations).

(3) Multi‐faceted interventions:  Some studies manipulate many variables and as such span across the above three broad categories of environmental interventions (such as when a whole ward is redesigned; Leather 2003). We have included these studies in the review provided they were not confounded with non‐environmental changes, such as changes to policy.

We excluded studies from the review if the intervention was not clearly defined (to the extent that it could be replicated). In order to meet this requirement, studies must have, where applicable, either:

provided the manufacturing details of the intervention being assessed, if appropriate;
provided pictures or diagrams, if appropriate;
provided a detailed description of the objective properties of the intervention, (e.g. an intervention of colour change needs to describe the specific hue; simply stating 'blue' is not specific enough);
provided a contact from which more detailed information could be sought.

All studies were carried out in a hospital setting. A hospital was defined (Ward 2008) as a health facility that:

provides communal care where there is an expectation that this care is time limited;
provides overnight accommodation;
provides nursing and personal care;
provides for people with illness and disability.

This definition includes hospices.

Studies may have been conducted in any area of the hospital grounds, such as general wards, specialist wards (e.g. Intensive Care Units), waiting rooms, common areas, and gardens.

Types of outcome measures

This review included all validated health‐related patient outcomes reported in the research. Outcomes of interest included validated measures of: anxiety; pain; length of hospital stay; patients' satisfaction; quality of sleep; aggression and mood; physiological outcomes; medication utilisation; hospital‐acquired infections; and mortality. We included a broad range of outcomes since the environment may affect many aspects of a patient's physical and psychological health and different interventions may be applicable to some outcomes and not others. When summarising the results of studies, we have reported up to five relevant outcomes for each comparison and grouped the remaining reported outcomes for that intervention under a heading "other outcomes".

Search methods for identification of studies

Electronic searches

We searched databases covering the fields of health, medicine, psychology and architecture. To identify possible studies, a strategy for MEDLINE was developed using relevant MeSH terms and text words (dates searched 1902 to December 2006; Appendix 1). This strategy was adapted for other databases searched. These included: the Cochrane Central Register of Controlled Trials (CENTRAL; last searched January 2006; Appendix 2); EMBASE (January 1980 to February 2006; Appendix 3); Royal College of Nursing/British Nursing Index (BNI; January 1985 to August 2005; Appendix 4); PsycINFO (January 1806 to December 2006; Appendix 5); Construction and Building Abstracts (CBA; January 1985 to August 2005; Appendix 6); Royal Institute of British Architects (RIBA) library online catalogue (last searched December 2005; Appendix 7); InformeDesign (last searched January 2005; Appendix 8); NHS Estates Knowledge and Information Portal (Architecture in Healthcare Database; complete database searched November 2004); Avery Index to Architectural Periodicals (January 1996 to December 2001; Appendix 9); Cumulative Index to Nursing and Allied Health Literature (CINAHL; January 1982 to August 2005; Appendix 10); Web of Science (January 1970 to January 2006; Appendix 11); Applied Social Sciences Index and Abstracts (ASSIA; January 1987 to December 2004; Appendix 12); UK National Research Register (last searched February 2006; Appendix 13); Architecture Publication Index (January 1978 to March 2002; Appendix 14); Turning Research Into Practice (TRIP) database plus (last searched January 2006; Appendix 15); and Zetoc (The British Library's Electronic Table of Contents; last searched January 2006; Appendix 16). This review is currently being updated (MEDLINE last search October 2010; Appendix 17), see Studies awaiting classification.

Searching other resources

We reviewed reference lists of relevant articles, sourced grey literature from relevant organisations' web pages (e.g. Centre for Health Design, NHS Estates and Facilities Division), and contacted researchers for further information and other potential studies.

Data collection and analysis

Selection of studies

One review author (AD) conducted the initial search (Trials Search Co‐ordinator 'JM' conducted the EMBASE search). The initial search of databases retrieved 78,480 'hits'; these were screened for relevance and the majority of deleted records were double‐checked by a second review author. After screening, 15,140 titles were recorded on the main review database. Two review authors (AD/RS/DW/TD/EG) independently screened the studies obtained from the initial search. Each title was rated as 'hit' (maybe eligible), 'unsure' (probably not eligible) or 'reject' (not to be assessed further). Any disagreement with regard to eligibility was resolved through a third review author and discussion where necessary. We obtained full‐text (English and non‐English) papers for the 'hits' and abstracts for the 'unsures'. All abstracts (2029 total) were assessed independently by two review authors (AD/RS/DW/TD/EG) and rated as 'hit', 'unsure', or 'reject'. We then obtained full‐text papers (524 total) for 'hits' and 'unsures' and these were assessed for inclusion by at least two review authors. We discussed full‐text papers rated as 'unsure' in group meetings. A final corpus of 102 studies was selected for inclusion in the review (see Figure 1 for a flow diagram of the study process).

Data extraction and management

Two review authors undertook data extraction independently, using a modified version of the EPOC data collection checklist (AD/DG/HM/RS/DW/TD/EG). Any disagreements were resolved through discussion between review authors.

Assessment of risk of bias in included studies

Retrieved studies were independently evaluated for risk of bias by two review authors (AD/DG/HM/RS/DW/TD/EG), using the criteria described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008). For studies where there was difference of opinion a consensus was reached through discussion between review authors.

Data synthesis

The results section is structured alphabetically by intervention (and control) with multi‐intervention studies (e.g. whole ward redesign) being grouped as a separate category. Where appropriate, we have summarised the results of each intervention against different types of control (e.g. other form of environment, standard care) separately; this is because the effectiveness of interventions will vary depending on the comparison, and it may not be appropriate to combine all different types of control group together. Outcomes for individual interventions are looked at in turn and the heterogeneity of the studies explored.

For continuous variables, we calculated a mean difference (MD) for identical measures, or standardized mean difference (SMD), where different techniques were used to measure the same outcome domain, with 95% confidence intervals (CI) for each study. For dichotomous variables, we calculated a risk ratio (RR) with 95% CI. We used sensitivity analyses to explore the influence of risk of bias ('similarities at baseline'; 'sequence generation'; 'concealment of allocation'; 'completeness of data'; and 'blinding of healthcare personnel'), and the influence of deciding to include individual studies that were ambiguous as to whether they met the inclusion criteria.

Where statistical analyses were inappropriate or unfeasible, a discursive account of the results is presented with supporting tables. When it was appropriate to combine the studies, we used a random‐effects model of meta‐analysis. We have presented continuous data that were reported using medians and ranges in tables only.

Subgroup analysis and investigation of heterogeneity

We identified the presence of statistical heterogeneity by visually examining the forest plots, and using the I² test for heterogeneity (where it was considered that: 0% to 40% might not be important; 30% to 60% may represent moderate heterogeneity; 50% to 90% may represent substantial heterogeneity; 75% to 100% represents considerable heterogeneity). The importance of the observed value of I² was evaluated in conjunction with (i) magnitude and direction of effects and (ii) strength of evidence for heterogeneity (i.e. P value from the Chi² test). We explored heterogeneity qualitatively (based on the characteristics listed below), and with subgroup analyses (where appropriate).

Heterogeneity was explored based on:

case mix (reason for hospitalisation; psychiatric/non‐psychiatric);
hospital visit characteristics (in‐patient/out‐patient/day‐patient; area of hospital studied);
geography (countries in which studies were undertaken).

To aid interpretation, we have presented the findings for anxiety from studies on music in subgroups (this decision was made post‐hoc and is based on the following rationale); Given the temporal dependence of anxiety as a transitional state (Spielberger 1983), the studies have been grouped according to the methodological criteria of when the musical intervention was provided, i.e. according to whether music was provided in the waiting period prior to a medical procedure (and hence the outcome of anxiety was obtained after the music intervention but before the medical procedure), or if music was provided throughout a medical procedure (anxiety was measured after both the music and medical procedure), or music was provided in the post‐operative period, or in an intensive care environment. We have displayed Chi² tests assessing subgroup differences where appropriate (i.e. when the data presented in each subgroup is independent).

Results

Description of studies

Overall, 102 studies have been included in this review; one study was published twice on the same population but with different outcomes reported (Barnason 1995/1996) and two studies (Barnason 1995/1996 ; Lembo 1998) explored more than one type of intervention. Environmental interventions explored were: those that provided positive distracters to complement healthcare treatment already being administered, to include aromas (two studies), audiovisual distractions (five studies), decoration (one study), music (85 studies); those that reduced environmental stressors by implementing physical changes, to include studies on air quality (three studies), bedroom type (one study), flooring (two studies), furniture and furnishings (one study), lighting (one study), and temperature (one study);and multifaceted interventions (two studies). No studies meeting the inclusion criteria were found to evaluate: art, access to nature for example through hospital gardens, atriums, flowers, and plants, ceilings, interventions to reduce hospital noise, patient controls, technologies, way‐finding aids, or the provision of windows.

Studies awaiting assessment

We have two studies published in Korean, which we have not yet been able to assess due to translation difficulties (Hur 2005; Son 2006), one ongoing study (Characteristics of ongoing studies), and a further 66 studies awaiting assessment which are part of an ongoing update of this review (Studies awaiting classification).

Risk of bias in included studies

A summary of risk of bias judgements for all studies can be seen in Figure 2. A narrative description for each intervention type is given below.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Effects of interventions

Providing positive distracters

Aromas

Description of studies on aromas:

One RCT (Graham 2003) and one CCT (Holmes 2002) have been included on the use of aromas in the hospital (Table 1). These studies investigated the use of aromas in 328 patients overall; in Graham 2003 it is unclear how many participants there are per group, and Holmes 2002 is a cross‐over trial of 15 psychiatric patients. The overall mean age was 65.64 years old, with 169 males and 159 females included in the studies. Studies were conducted in Australia and England. Patient groups assessed were those undergoing radiotherapy treatment, and psychiatric in‐patients in a psychogeriatric ward.

1. Aromas: Characteristics of included studies.

Study ID	Methods	Participants	Interventions	Outcomes
Graham 2003	RCT; 3 parallel groups.	DESCRIPTION: 313 patients undergoing radiotherapy, in Australia.  NUMBERS: Unclear how many patients per group.  AGE, mean (range): 65 (33‐90) years old.  GENDER (male/female): 163/150.  ETHNICITY: not described.  INCLUSION CRITERIA: If a course of eight or more fractions of radiotherapy was prescribed.  EXCLUSION CRITERIA: not described.	FRAGRANT PLACEBO: Patients were administered the carrier oil with low‐grade essential oils. The carrier oil was sweet almond cold‐pressed pure vegetable oil. The low‐grade fractionated oils (lavender, bergamot, and cedarwood) were of unknown purity (supplied by Naturistics, Hornsby, Australia). These fractionated oils were diluted with the carrier oil in a ratio of 1:2.  NON‐FRAGRANT PLACEBO: Patients were administered the carrier oil only: sweet almond cold‐pressed pure vegetable oil.  PURE ESSENTIAL OIL: 100% pure essential oils of lavender, bergamot, and cedarwood were administered in a ratio of 2:1:1 (supplied by "In Essence").    All patients were administered their study treatment via a necklace with a plastic‐backed paper bib, donned before radiotherapy treatment each day and removed after exiting the treatment bunker. Three drops of oil were applied to the bib. Typical duration lasted 15‐20 minutes. Patients were seated in waiting areas segregated according to study arm allocation to avoid cross‐exposure.	ANXIETY, DEPRESSION, and FATIGUE: Measured via the Hospital Anxiety and Depression Scale (HADS), and the Somatic and Psychological Health Report (SPHERE), which is composed of the General Health Questionnaire (GHQ) and Symptoms of Fatigue and Anergia (SOFA) scales.    In a multivariate analysis:  There were significantly fewer patients with anxiety >7 in the non‐fragrant placebo arm than both the essential oil (Odds ratio = 2.6, 95% CI = 1.1 to 6.1), and fragrant placebo (Odds ratio = 2.8, 95% CI = 1.1 to 6.7) groups.    There were no significant differences between groups in depression scores, the General Health Questionnaire, and fatigue scale.
Holmes 2002	CCT; Cross‐over trial, 2 conditions.	DESCRIPTION: 15 psychiatric inpatients in the communal area of a long‐stay hospital psychogeriatric ward for patients with behavioural problems, in England.  NUMBERS: 15 patients; cross‐over trial.  AGE, mean (SD): 79.0 (6.3) years old.  GENDER (male/female): 6/9.  ETHNICITY: not described.  INCLUSION CRITERIA: International classification of disease (ICD)‐10 diagnostic criteria for severe dementia; evidence of agitated behaviour‐ defined as scoring > 3 on the Pittsburgh Agitation Scale at some point each day over the period of a week.  EXCLUSION CRITERIA: none described.	LAVENDER: The communal area of the unit was diffused with a standard concentration of lavender oil (2%), using three aroma‐streams for a period of two hours between the period of 4pm and 6pm.  PLACEBO: The communal area of the unit was diffused with water, using three aroma‐streams for a period of two hours between the period of 4pm and 6pm.    A total of five treatments and five placebo trials were carried out for each patient over a period of two weeks.	AGITATION: Measured on the 16‐point Pittsburgh Agitation Scale by a blinded observer for the final hour of each two hour study period. Outcomes are presented as median scores for each patient in each condition.    9 patients showed an improvement with lavender.  5 patients showed no change with lavender.  1 patient showed a worsening of condition with lavender.  Wilcoxon Signed‐Ranks test, P = 0.016    Of the 4 patients with Alzheimer's disease, 3 improved and 1 showed no change; of the 7 patients with vascular dementia, 5 improved and 2 showed no change; of the 3 patients with Dementia with Lewy Bodies, 2 showed no change and 1 worsened; the 1 patient with Fronto‐temporal lobe dementia improved.

Study ID	Reason for exclusion
Anderson 2004	Intervention
Burns 2000a	Study design
Burns 2000b	Study design
Burns 2002	Study design
Bykov 2003a	Setting and population
Girard 2004	Editorial
Hudson 1995	Study design
Hudson 1996	Outcomes
Itai 2000	Study design
Kane 2004	Data unsuitable for cross‐over study
Kirkpatrick 1998	Commentary
Lehrner 2000	Setting
Louis 2002	Setting
Redd 1994	Aromas administered via nasal cannula, judged to be too invasive to constitute an 'environmental' intervention.
Tate 1997	Intervention; outcome not validated

Study ID	Reason for exclusion
Bower 1995	Qualitative report
Breslow 1993	Descriptive article
De Jong 1972	Participants
Finkelstein 1971	Intervention interactive
Finlay 1993	Qualitative report
Green 1994	News article
Guillemin 2000	Qualitative
Homicki 2004	Descriptive article
Litch 2006	Narrative article
Mellor 2001	Commentary
Palmer 1999	No group comparisons presented, unable to obtain further details from authors
Staricoff 2001	Study design
Staricoff 2003a	Study design (part of same study as Staricoff 2001)
Ulrich 1993b	Conference abstract, unable to obtain further details from author
Wikström 1992	Setting
Wikström 1993	Setting

Study ID	Reason for exclusion
Allen 1989	Intervention
Egger 1981	Study design
Friedman 1992	Study design
Hoffman 2000	Intervention‐ interactive virtual reality
Hoffman 2001	Intervention‐ interactive virtual reality
Holden 1992	Intervention‐ patient education video
Martin 1999	Inadequate information provided (Ulrich study)
Oyama 2000	Intervention interactive
Pruyn 1998	Unclear validity of outcomes
Schneider 2003	Intervention interactive
Schneider 2004	Intervention interactive
Schofield 2000	Intervention‐ snoezelen
Singer 2000	Population, < 90% over 18 years old.
Tse 2003	Setting
Ulrich 2003	Setting
Wint 2002	Participants not adults

Study ID	Reason for exclusion
Becker 1980	Outcomes not validated
Cooper 1989	Qualitative report
Dickinson 1995	Setting
Hewawasam 1996	Study design
Hussian 1987	Study design
Jacobs 1974	Participants
Knobel 1985	Descriptive article
Namazi 1989	Study design
Rabin 1981	Descriptive article
Rice 1980	Outcomes
Steer 1975	Counfounding
Steffes 1985	Staffing confound

Study ID	Reason for exclusion
Abramson 1966	No data presented‐ summary paper
Bampton 1997	Validity of outcomes
Beck 1991	Setting
Boeke 1988	Validity of outcomes
Bonke 1982	Outcomes not reported for relevant groups; data collection methods unclear.
Bozcuk 2006	Study design
Browning 2001	Intervention provided outside of hospital
Byers 1997	Study design
Bykov 2003b	Setting and population
Cai 2001a	Intervention
Cai 2001b	Intervention
Ceccio 1984	Intervention‐ relaxation technique
Chikamori 2004	Intervention
Clair 1994	Questionable validity of outcome, relevant data not presented
Clair 2006	Setting
Clark 1998	Setting
Cooper 1991	Qualitative report
Courtright 1990	Outcome measure
Cunningham 1997	Outcomes
Davis 1992	Setting
De l'Etoile 2002	Intervention
Denney 1997	Setting
Dritsas 2004	Intervention not well defined
Durham 1986	Intervention provided during education programme
Eisenman 1995	Study design
Escher 1993	Music therapist confound; group differences in timing of data collection
Fauerbach 2002	Intervention included coaching of participants
Ferguson 1997	Setting not hospital
Fox 1986	Study design
Frank 1985	Study design
Fratianne 2001	Intervention interactive music therapy
Frid 1981	Interventions not suitable for inclusion
Good 1995	Invention group provided 20mins coaching.
Good 1998	Intervention group provided reinforcement and training‐ bias
Good 1999	Intervention group provided coaching on relaxing
Good 2001	Secondary analysis of previous study
Good 2002	Secondary analysis of previous study
Good 2005	Secondary analysis of previous study
Götell 2002	Setting; qualitative
Götell 2003	Qualitative
Guzzetta 1989	Relaxation (psychological) technique use with intervention
Harris 1992	Outcomes not health‐related
Haythornthwaite 2001	Intervention‐ taught techniques
Helmes 2006	Outcomes
Hooper 1992	Case study
Hsu 1998	Intervention not well defined
Huffman 1994	Intervention not well defined
Janelli 1997	Policy confound (restraints use)
Janelli 1998	Policy confound (restraints use)
Janelli 2000	Policy confound (restraints use)
Janelli 2002	Outcome measure
Janelli 2004	Outcome measure
Janiszewski 1980	Study design
Jarvis 1979	Conference abstract‐ not enough detail
Jonas 1988	Study design
Kaiming 1997	Intervention not well defined
Kane 2004	Data unsuitable for cross‐over study
Kim 2005	Setting
Kimata 2003	Setting
Kopp 1991	Intervention not well defined
Kumar 1992	Validity of outcomes
Kwon 2006	Study design‐ selection of participants by matching, different wards assigned to different conditions.
Lai 1999	Unable to clarify discrepancies in data with author
Lai 2005	Setting
Lai 2006	Setting; Duplicate
Laurion 2003	Intervention began before admission
Lazaroff 2000	Unclear methods and data
Leão 2004	Study design
Locsin 1979	Intervention not well described (CCT)
Locsin 1981	Intervention not well described (CCT)
McCaffrey 2004	Outcomes not validated/reliable
Mellgren 1967	Study design
Mihara 2005	Lack of information
Miluk‐Kolasa 1994	Confounding
Miluk‐Kolasa 1996	Intervention not well described
Miluk‐Kolasa 2002	Intervention not well described
Moss 1988	Intervention not well described, no data presented (CCT)
Murrock 2002	Setting

Study ID	Reason for exclusion
Norberg 1986	Study design
Prensner 2001	Study design
Ragneskog 1996	Setting
Rakshy 1997	Inappropriate methods and analysis
Routhieaux 1997	Outcomes not patient‐related
Salmore 2000	Intervention
Sármány 2006	Patients allocated retrospectively to music or control, depending on whether or not they had noticed or heard any music playing (unpublished information).
Satoh 1983	Intervention not well described
Schuhl 1985	Data collection tool not validated
Sherratt 2004	Outcomes not validated
Shertzer 2001	Policy change‐ staff asked to remain quiet on intervention days
Sidorenko 2000a	Therapy as treatment
Siedliecki 2006	Setting
Spintge 2000	Overview‐ insufficient detail
Spitzer 2005	Music not well described; cross‐over trial with and with‐out vibration
Standley 1992	Setting
Staricoff 2003a	Study design
Staricoff 2003c	Study design
Staricoff 2003d	Study design
Staricoff 2003e	Study design
Steelman 1990	Intervention not well defined
Stermer 1998	Outcomes not validated
Stone 1989	Study design
Strauser 1997	Setting
Swinford 1987	Intervention
Thorgaard 2004	Outcomes not validated
Thorgaard 2005	Study design
Tierney 1978	Study design; outcomes
Uedo 2004	Insufficient information (intervention and data)
Updike 1987	Study design
Updike 1990	Study design
Vollert 2002	Test (not clinical) situation, healthy controls
Vollert 2003	Setting
Walther‐Larsen 1988	Intervention not well defined; validity of outcomes unclear
Yilmaz 2003	Inappropriate control‐ drugs
Zhong 2005	Duplicate study (Lee 2005)

Outcome	Detailed RCTs (N)	Participants (N)	Heterogeneity (%)	Results	Other RCTs	Participants (N)	Findings
Oxygen saturation	N = 1  Nilsson 2005	Total = 50  Music = 25  Control = 25	N/A	MD 1.60, 95% CI 0.05 to 3.15, P value = 0.04  In favour of music.	N = 1  Chlan 1995	Total = 20  Music = 11  Control = 9	No significant difference between groups.
Airway pressure	None	N/A	N/A	N/A	N = 1  Chlan 1995	Total = 20  Music = 11  Control = 9	No significant differences between groups.
Skin conductance	N = 2  Wang 2002;  Guo 2005	Total = 186  Music = 96  Control = 90	I² = 81.7% (one study significant, one study non‐significant)	SMD 0.13, 95% CI −0.55 to 0.80, P value = 0.71 (Analysis 3.5).	None	N/A	N/A
Heart rate variability (RR intervals, low and high frequency bands, total power, low/high frequency ratio)	None	N/A	N/A	N/A	N = 1  Chui 2003	Total = 68  Music = 34  Control = 34	Heart rate variability data (high frequency power, logarithm of low frequency, and high/low frequency ratio) showed significant positive changes in the music group but not control group. Other variables (RR intervals, low and high frequency bands, low frequency power, and logarithm of high frequency) were non‐significant.
Bispectral index (mean, time to reach BIS 60)	N = 2  Ganidagli 2005;  Zhang 2005	Total = 160  Music = 80  Control = 80	N/A (studies reported different outcomes)	Bispectral index: MD 1.00, 95% CI −1.27 to 3.27, P value = 0.39;  Time to reach BIS 60: MD −5.00, 95% CI −15.55 to 5.55, P value = 0.35	None	N/A	N/A
Stress hormones (Cortisol, epinephrine, norepinephrine, adrenocorticotropic hormone‐ ACTH)	N = 3  Migneault 2004;  Wang 2002;  Guo 2005	Total = 216  Music = 111  Control = 105	Cortisol I² = 51.8% (3 studies)  Others I² = 0% (2 studies)  ACTH, N/A (1 study)	Cortisol: SMD −0.32, 95% CI 0.73 to 0.09, P value = 0.13;  Epinephrine: SMD −0.02, 95% CI −0.38 to 0.33, P value = 0.91;  Norepinephrine: SMD −0.08, 95% CI −0.44 to 0.27, P value = 0.64;  ACTH: SMD −0.44, 95% CI −1.17 to 0.28, P value = 0.23 (Analysis 3.6)	N = 1  Nilsson 2005	Total = 75  Intra‐operative music = 25  Post‐operative music = 25  Control = 25	No differences in cortisol levels at any time between groups. Change scores at 2 hours post‐operatively were significantly greater in the post‐operative music group than control. Blood glucose levels did not differ between groups at any time.
Mood	N = 1  Chlan 1995	Total = 20  Music = 11  Control = 9	N/A	MD −8.50, 95% CI −18.55 to 1.55, P value = 0.10	None	N/A	N/A
Abnormal events (hypoxaemia, hypotension, hypertension, bradycardia, tachycardia, respiratory depression, pruritis)	N = 1  Andrada 2004	Total = 118  Music = 63  Control = 55	N/A	Cardio‐respiratory incidents = 0;  Oxygen desaturation = 0;  Arterial hypertension = 1 control;  Arterial hypotension = 2 control;  Bradycardia = 3 music, 2 control;  Tachycardia = 1 music, 1 control.	N = 1  Cepeda 1998	Total = 193  Music = 97  Control = 96	Vomiting (Intra‐operatively/PACU): Music = 0/0%, Control = 2.2/0%  Pruritus (Intra‐operatively/PACU): Music = 26.6/27.6%, Control = 26.1/26.1%  Bradycardia (intra‐operatively/PACU): Music = 0/0%, Control = 2.3/0% Unclear missing data as presented in % values.
Headache	N = 1  Nilsson 2003b	Total = 115  Music = 59  Control = 56	N/A	MD 0.00, 95% CI −0.15 to 0.15, P value = 1.00	None	N/A	N/A
Fatigue	N = 1  Nilsson 2003b	Total = 115  Music = 59  Control = 56	N/A	MD −0.30, 95% CI −0.78 to 0.18, P value 0.22	N = 1  Nilsson 2003a	Total = 151  Intra‐operative music = 51  Post‐operative music = 51  Control = 49	There were no significant differences between groups.
Urinary problems	N = 1  Nilsson 2003b	Total = 115  Music = 59  Control = 56	N/A	MD −0.10, 95% CI −0.40 to 0.20, P value = 0.51	None	N/A	N/A
Well‐being	N = 1  Nilsson 2003b	Total = 115  Music = 59  Control = 56	N/A	MD 0.30, 95% CI 0.02 to 0.58, P value = 0.03 in favour of music group.	None	N/A	N/A
Nausea	N = 2  Nilsson 2003b;  Cepeda 1998	Total = 308  Music = 156  Control = 152	N/A (different methods of measurement)	MD −0.20, 95% CI −0.50 to 0.10, P value = 0.19    OR 0.82, 95% CI 0.35 to 1.93, P value = 0.64	N = 1  Nilsson 2003a	Total = 151  Intra‐operative music = 51  Post‐operative music = 51  Control = 49	There were no significant differences between groups.
Satisfaction	N = 1  Zhang 2005	Total = 110  Music = 55  Control = 55	N/A	MD 1.60, 95% CI 1.29 to 1.91, P value < 0.00001  in favour of music group	N = 2  Cepeda 1998;  Nilsson 2003a	Total = 344  Intra‐operative music = 148  Post‐operative music = 51  Control = 145	There were no significant differences between groups.
Length of stay	N = 1  Blankfield 1995	Total = 61  Music = 32  Control = 29	N/A	MD 0.00, 95% CI −0.99 to 0.99, P value = 1.00	N = 2  Harikumar 2006;  Heitz 1992	Total = 118  Music = 58  Control= 60	Harikumar 2006 reports that recovery time was significantly longer (difference in medians = 10 minutes) in the control group. Heitz 1992 reports no significant differences between groups.
Activities of daily living	N = 1  Blankfield 1995	Total = 61  Music = 32  Control = 29	N/A	MD −0.30, 95% CI −2.63 to 2.03, P value 0.80	None	N/A	N/A
Serum interleukins (IL‐6)	N = 1  Zhang 2005	Total = 110  Music = 55  Control = 55	N/A	MD −7.40, 95% CI −22.61 to 7.81, P value = 0.34	None	N/A	N/A
Induction time of sedation (minutes)	N = 1  Zhang 2005	Total 110  Music = 55  Control = 55	N/A	MD −6.00, 95% CI −10.49 to −1.51, P value = 0.009 in favour of music.	None	N/A	N/A

Study ID	Reason for exclusion
DeSchriver 1990	Setting
Morsley 1999	Commentary
Rice 1980	Outcomes
Siegman‐Igra 1986	Study design
Ulrich 1984	Study design‐ retrospective matched pairs

Study ID	Reason for exclusion
Alberti 2001	Study design
Azer 1971	Setting
Baird 1969	Outcomes
Bodey 1969	Study design (no control)
Bodey 1971	Study design (matched pairs)
Choctaw 1984	Policy confound (sterile versus clean attire)
Chow 2005	Study design (computer modelling)
Dekker 1994	Confounding
Demling 1978	Patients‐ mix of adults and children, data inseparable
Freireich 1975	Preliminary report of Rodriguez 1978; policy confound
Friberg 1999	Sham operations
Friberg 2003	One patient health‐related outcome reported (surgical site infections), but not enough detail on how it was assessed or if it was noted on an 'ad hoc' basis.
Gundermann 1974	Not patient outcomes
Lai 2001	Study design
Legg 1970	Not patient outcomes; test scenario
Lidwell 1969	Not patient outcomes; test scenario
Lidwell 1975	Study design
Lidwell 1982	Some relevant subgroups within study however cannot separate data (number of re‐operations in each subgroup). Additionally, there are discrepancies in reporting with Lidwell 1984 with 185 patients switching subgroups.
Lidwell 1984	Same study as Lidwell 1982. Non‐transparant reporting of findings‐ data not usable. Discrepancies between Lidwell 1982 and Lidwell 1984.
Lowbury 1971	Population‐ age
Lowbury 1978	Preliminary report of Lidwell 1982 and Lidwell 1984
May 1984	Study design
Passweg 1998	Retrospective study; population (age)
Petersen 1987	Policy (decontamination) changes
Qian 2006	Mock setting
Rodriguez 1978	Policy confounding
Schimpff 1975	Policy confounding
Sherertz 1987	Study design
Steingold 1963	Study design
Whyte 1968	Not patient outcomes
Yates 1973	Policy confounding

Study ID	Reason for exclusion
Armstrong 1984	Review article
Burke 1977	Participants (age)
Chaudhury 2003	Cross‐sectional survey and qualitative interviews
Dekker 1994	Confounding
Dolce 1985	Retrospective study
Duckworth 1988	Policy changes
Freireich 1975	Preliminary report of Rodriguez 1978; policy confound
Gabor 2003	Healthy participants received intervention
Hahn 1995	Study design
Harmankaya 2002	Study design
Hendrich 2004	Study design
Herr 2003	Study design, outcomes
Ittelson 1970	Study design
Janssen 2000	Outcome measure
Janssen 2001	Participants
Kaldenberg 1999	Study design
Kibbler 1998	Study design; confounding
Kulik 1996	Intervention
Leigh 1972	Study design
Levine 1973	Confounding
Lewis 1999	Study 1: inappropriate control; Study 2: intervention
Lidwell 1966	Study design
May 1984	Study design
McConnell 2005	Study design; unclear intervention
Miller 1998	Participants; Study design
Morgan 1998	Setting
Mulin 1997	Study design
Nauseef 1981	Policy changes
Parker 1965	Patients‐ 38% <10 years old
Preston 1981	Study design
Ribas‐Mundo 1981	Intervention (non‐environmental changes)
Rodriguez 1978	Policy confounding
Schimpff 1975	Policy confounding
Shooter 1963	Policy change
Silini 2002	Study design
Thompson 2002	Study design
Walsh 1989	Policy changes
Wilkins 1988	Study design
Williams 1962	Study design
Williams 1969	Study design‐ no control
Wood 1977	Validity of outcomes
Yates 1973	Policy confounding

Study ID	Methods	Participants	Interventions	Outcomes	Notes
Barnason 1995/1996	RCT; 3 parallel groups.	DESCRIPTION: 96 in‐patients in the cardiovascular ICU and progressive care units having undergone elective coronary artery bypass grafting, in USA.  NUMBERS: Music group = 33, Music + video group = 29, Scheduled rest group = 34.  AGE, mean (SD): 67 (9.9) years old.  GENDER (male/female): 65/31.  ETHNICITY: White = 96 (100%)  INCLUSION CRITERIA: Orientated to person, time and place; speak and read English; 19 years or older; extubated within 12 hours of surgery; removal of intra‐aortic balloon pump within 12 hours of surgery.  EXCLUSION CRITERIA: Currently using one of the intervention techniques; major hearing deficit.	MUSIC GROUP: Choice of 5 tapes: 'Country Western Instrumental' or 'Fresh Aire' by Mannheim Steamroller, 'Winter into Spring' by George Winston, or 'Prelude' or 'Comfort Zone' by Steven Halpern. Played via headphones for 30 minutes.  MUSIC + VIDEO GROUP:  Barnason 1995 states:  Choice of 2 Steven Halpern tapes: 'Summer Wind' or 'Crystal Suite'. Each is 30 minutes of soft instrumental with visual imaging.  Zimmerman 1996 states:  Choice of three 30 minute videocassettes by Pioneer Artist ('Water's Path', 'Western Light', or 'Winter').  SCHEDULED REST: 30 minutes of rest in bed or chair, visitors and staff requested not to disturb.    2 x 30 min intervention periods during afternoons of post‐operative days 2 and 3. Lights dimmed.	Barnason 1995 reports:  STATE ANXIETY: measured using STAI at three time‐points: pre‐operatively, before intervention on 2nd post‐operative day, and after intervention on 3rd post‐operative day.  ANXIETY: taken using NRS before and after each intervention session.  PHYSIOLOGICAL: HR (bpm) and BP (mm Hg) taken using the Kendall BP Monitor (Model 8200)‐ not enough data presented for extraction.  MOOD: Measured using a NRS‐ not a validated outcome.    Zimmerman 1996 reports:  PAIN: Pain was measured with a 10‐point VRS before and after each session, and with the McGill Pain Questionnaire (scores are given for the subscales and the present pain index rating scale) administered once prior to the first session, and once after the second session.  SLEEP: Measured with the Richards‐Campbell Sleep Questionnaire (RSQ), administered between 7am and 9am on the third post‐operative day.	Data extracted for state anxiety (STAI measure). Pain data are extracted for the end values on the VRS.    Patients in the music group showed a significant improvement in mood after the 2nd intervention when controlling for pre‐intervention mood rating. No differences between groups were found for anxiety on either data collection tool. Physiological measures did not differ between groups, however there were significant differences over time (regardless of group), indicating a generalised relaxation response.  Authors conclude that although no intervention was overwhelmingly superior, all groups demonstrated a relaxation response.
Diette 2003	RCT; 2 parallel groups.	DESCRIPTION: 80 in‐patients and out‐patients undergoing FB in Mariland, USA.  NUMBERS: Bedscapes group = 41, Control = 39 patients.  AGE, mean (range): Bedscapes = 52.3 (21‐88); Control = 55.3 (30‐90).  GENDER (Male/Female): Bedscapes = 16/25; Control = 22/17.  ETHNICITY (White/African‐American): Bedscapes = 25/16; Control = 28/11.  INCLUSION CRITERIA: 18 years or older, undergoing FB.  EXCLUSION CRITERIA: Non‐English speaker, contact isolation, presence of encephalopathy or significant alteration in mental status, sensory deficits that preclude use of visual/auditory aid.	BEDSCAPES GROUP: Countryside river scene with associated sounds of nature played through headphones. Intervention available before, during, and after FB procedure. The scene was mounted by the bedside in the recovery area and on the ceiling in the procedure room.  CONTROL GROUP: standard care.	ANXIETY: State anxiety via STAI;  PAIN: Pain control during procedure measured by VRS. Values presented as % with good/excellent pain control. Due to unclear missing data (> 10%), it is unclear how many people this represents.  ABILITY TO BREATHE: (poor to excellent) rating scale. Validity unclear.  SATISFACTION WITH CARE: Ratings of: willingness to return, privacy, safety, overall rating of facility. Validity unclear.    Outcomes obtained via a follow‐up survey administered on the second day following the procedure. Out‐patients completed form and returned it by mail. In‐patients forms were collected from their hospital room.	SDs for anxiety have been estimated from P value of a t‐test.    Adverse events: 1 patient in the treatment group urinated on the bronchoscopy table. The patient felt that this had occurred because of hearing sounds of running water.
Lee 2004a	RCT; 3 parallel groups.	DESCRIPTION: 157 day‐patients undergoing colonoscopy in an Endoscopy Suite in Hong Kong, China.  NUMBERS: Visual distraction = 52 patients, Audiovisual distraction = 52 patients, Control group = 53 patients.  AGE, mean (SD): Visual distraction = 45.6 (10.2), Audiovisual distraction = 48.8 (11.3), Control group = 46.3 (11.4).  GENDER (male/female): Visual distraction = 25/27, Audiovisual = 27/25, Control group = 23/30.  ETHNICITY: not described.  INCLUSION CRITERIA: Undergoing elective day‐case colonoscopy.  EXCLUSION CRITERIA: History of allergy to propofol and/or alfentanil. Receive a colectomy.	VISUAL DISTRACTION: Eyetreck system (olympus) with preset home made movie (mainly scenic views), patient wears earphones but with no sound.  AUDIOVISUAL DISTRACTION: Same as visual distraction with the addition of classical music played through earphones.  CONTROL: Standard care.  All groups received PCS using a mixture of propofol and alfentanil.	PAIN: scored using 10 cm VAS;  SATISFACTION: measured using 10 cm VAS;  Willingness to repeat procedure (using 10 cm VAS);  ANALGESICS: Dose of PCS consumed;  PHYSIOLOGICAL:  Hypotensive episodes;  Oxygen desaturation;  RECOVERY TIME: nurse assessed
Lembo 1998	RCT; 3 parallel groups.	DESCRIPTION: 37 patients undergoing flexible sigmoidoscopy in Calfornia, USA.  NUMBERS: Audiovisual group = 13, audio alone group = 12, control group = 12.  AGE, mean (SD): Audiovisual group = 58 (7), Audio alone group = 60 (8), Control group = 59 (7) years old.  GENDER: Male = 37 (100%).  ETHNICITY: not described.  INCLUSION CRITERIA: Undergoing routine screening flexible sigmoidoscopy.  EXCLUSION CRITERIA: none described.	AUDIOVISUAL: Virtual‐i glasses, personal display system showing an ocean shoreline with corresponding sounds (via headphones)  AUDIO ALONE: Sounds of the ocean shoreline only played via headphones.  CONTROL: No intervention, standard care.	DISCOMFORT: Measured via VAS which asked patients to rate their level of abdominal discomfort from faint to severly intense.  STRESS SYMPTOMS: Measured 6 subscales (arousal, stress, anxiety, anger, fatigue, and attention) using 12 VAS.	Data for discomfort entered as pain scores.    Data extracted for review on anxiety and anger. Arousal and attention not considered health‐related outcomes.    There was no difference between groups on the stress and fatigue subscales, data not reported for extraction.
Miller 1992	RCT; 2 parallel groups.	DESCRIPTION: 17 in‐patients undergoing burns care treatment and dressings change in a Burn Special Care Unit, Cincinnati, USA.  NUMBERS: Audiovisual group = 9, Control group = 8.  AGE, mean: Audiovisual group = 40.9, Control group = 27.8  GENDER (male/female): Audiovisual group = 9/0, Control group = 7/1.  ETHNICITY (white/black): Audiovisual group = 8/1, Control group = 7/1.  INCLUSION CRITERIA: 10‐40% body surface burn; expected length of stay >/= 1 week; Adult patients, 18 years or older.  EXCLUSION CRITERIA: Substance abuse disorder; unable to see/or hear; psychotic; under 18 years old; cannot understand English; mentally retarded; disorientated; multiple trauma injuries.	AUDIOVISUAL GROUP: "Muralvision" (Muralvision Studios, Inc., Eugene, Ore.)‐ on a bedside television, video programmes composed of scenic beauty (ocean, desert, forest, flowers, waterfalls, and wildlife) with accompanying music.  CONTROL GROUP: Standard care.    Participants were exposed to their treatment group on 10 occasions during dressing change.	PAIN: Measured via the McGill Pain Questionnaire, with the Pain Rating Index and Present Pain Intensity scales.  ANXIETY: Measured via the STAI.    Outcomes were measured within 2 minutes at the end of each dressing change. Outcomes are reported as the overall means and standard errors for the 10 dressing changes.	For data extraction in the review, change scores from baseline were calculated and associated estimated standard deviations, using the F statistics provided.

Study ID	Methods	Participants	Interventions	Outcomes	Notes
Edge 2003	RCT; 4 parallel groups.	DESCRIPTION: 39 in‐patients (10 post‐operative for cardiac surgery, 29 undergoing cardiac observations) in a cardiac care unit in Florida, USA.  NUMBERS: Beige = 13, Purple = 10, Green = 9, Orange = 7.  AGE: 26 to 89 years old.  GENDER (male/female): 20/19.  ETHNICITY: not described.  INCLUSION CRITERIA: Admitted to unit between February and March 2003.  EXCLUSION CRITERIA: Colour blind; non‐English speaking; not able to understand or confused.	BEIGE: Walls remained original colour of beige (similar to Sherwin Williams colour SW6658) in four rooms.  PURPLE: Wall at foot of bed painted purple (SW6556) in two rooms.  GREEN: Wall at foot of bed painted green (SW6451) in two rooms.  ORANGE: Wall at foot of bed painted orange (SW6346) in two rooms.    Otherwise rooms were of same decor and intervention colours were co‐ordinated with colours already present in the rooms (e.g. on bed curtains). Artwork was removed from the rooms. Rooms were double occupancy with western outlook. Curtains were combination of orange, yellow, green, blue, and purple. Laminate countertops were green, and floors were orange and green. Furniture was neutral shades of white, grey, or beech wood.	ANXIETY: Measured via STAI on day of discharge (after 2 to 5 days in hospital). Presented as mean (SD). No significant differences reported.  LENGTH OF STAY: Extracted from patient notes by researcher (days). No SDs presented. No significant differences reported.  PAIN MEDICATION REQUESTS: Extracted from patient notes by researcher. Presented as number of patients making requests and number of requests made (no SDs presented), subgrouped by first day, middle days, and final day. No significant differences reported.	Partients in this study were not approached for informed consent until Day 3 of the study.

Study ID	Methods	Participants	Interventions	Outcomes	Notes
Augustin 1996	CCT; 2 parallel groups;  Allocated by alternation;  Blinding: NOT DONE;  Unit of allocation same as unit of analysis: DONE;  Power calculation: NOT DONE;  Outcomes obtained for >80% of patients: UNCLEAR;  Groups similar at baseline: DONE;  Protection against contamination: UNCLEAR;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 42 pre‐operative patients scheduled for ambulatory surgery in a Midwestern city hospital, USA.  NUMBERS: 21 patients per group.  AGE, mean (range): 47 (18‐73) years old.  GENDER (Male/Female): 25/17  ETHNICITY: All Caucasian.  INCLUSION CRITERIA: Any patient scheduled for ambulatory surgery who is over 15 years old.  EXCLUSION CRITERIA: Cognitive disability/delay; scheduled for cataract removal; hearing impairment; received a pre‐operative sedative; received colon preparation; lack sufficient time to participate.	MUSIC GROUP: Choice of 20 tapes (classical, environmental, new age, country‐western, general easy listening), played via headphones whilst resting in recliner chairs. Intervention lasted 15‐30 minutes depending on how long patient had left before surgery.  CONTROL GROUP: Standard care‐ not offered music. Activities were not monitored, friends and family may have been present, rooms contained magazines and a television.	PHYSIOLOGICAL MEASURES: measured using "standard noninvasive technology" before and after the intervention period.  RR (non‐significant):  Music group = 15.10 (2.28)  Control group = 16.00 (1.75)  BP (Non‐significant):  Music group: Systolic = 126.00 (15.47), Diastolic = 78.90 (12.54).  Control group: Systolic = 130.50 (17.14), Diastolic = 83.90 (9.45).  HR (Mean difference = ‐5.90, 95% CI = ‐11.56, ‐0.24):  Music group = 67.20 (8.87)  Control group = 73.10 (9.83).  ANXIETY: State anxiety measured using the STAI before and after intervention period. Non‐significant:  Music group = 35.38 (9.44)  Control group = 33.42 (9.62)
Binek 2003	CCT; 2 parallel groups;  Allocated by alternation;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: DONE;  Power calculation: UNCLEAR;  Outcomes obtained for >80% of participants: UNCLEAR;  Groups similar at baseline: demographics‐ DONE;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 301 outpatients and inpatients undergoing colonoscopy or esophagogastroduodenoscopy (EGD) in Switzerland.  NUMBERS: Music group = 151, Control group = 150.  AGE, mean: 59 years old.  GENDER (male/female): 173/128.  ETHNICITY: not described.  INCLUSION CRITERIA: not described.  EXCLUSION CRITERIA: Inability to answer questions due to severe illness, impaired consciousness, impaired hearing, and emergency interventions.	MUSIC GROUP: Patients could choose between "light" and "classical" music which was played in the background during the examination.  CONTROL GROUP: Standard care.	GENERAL EVALUATION: Not extracted for review.  PAIN SENSATION: Measured via 100mm VAS. No significant difference.  Music group: Mean (SD) = 7.66 (2.40),  Control group: Mean (SD) = 7.86 (2.45).  TOLERANCE OF PROCEDURE: Not extracted for review.  ROOM AMBIENCE: Not extracted for review.  SEDATION: Amount of midazolam and pethidine received was recorded, no significance difference between groups.  Pethidine:  Music group = 36.07 (18.88)  Control group = 37.10 (18.18)  Midazolam:  Music group = 3.01 (1.46)  Control group = 2.76 (1.37)	Paper reports outcomes as medians. Authors provided means and standard deviations on request for purposes of review.
Brunges 2003	CCT; 2 parallel groups;  Allocation method: UNCLEAR;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: UNCLEAR;  Unit of allocation same as unit of analysis: UNCLEAR;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: UNCLEAR;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 44 pre‐operative in‐patients in the holding area before total joint replacement, in Florida, USA.  NUMBERS: Graph depicts 22 patients in the music group and 21 patients in the control group (one person missing).  AGE, range: 39‐81 years old.  GENDER (male/female): 23/21  ETHNICITY: not described.  INCLUSION CRITERIA: not described.  EXCLUSION CRITERIA: not described.	MUSIC GROUP: Listened to music via headphones for a minimum of 30 minutes in the pre‐operative holding area. Music consisted of music‐enhanced nature sounds (sea, thunder, rainstorms, wind, and waterfalls).  CONTROL GROUP: Standard care.	The paper provides descriptive statistics only.  EPINEPHRINE: Sampled via indwelling catheter lines. Results given as a range:  Music group = 5‐10 mcg  Control group = 8‐32 mcg  LENGTH OF STAY: Presented in a bar chart. Means and SDs derived from the bar chart (NB. Two participants in the control group stayed for > 7 days, to calculate the mean and SD for this group, it was assumed these participants stayed for 7 days, thus providing a conservative estimate of the mean and SD):  Music group (n = 22) = 4.14 (0.83) days  Control group (n = 21) = 4.76 (1.18) days  A t‐test on this derived data provides a P value of 0.052 (95% CI = ‐1.25 to 0.01).
Dubois 1995	CCT; 2 parallel groups;  Allocated by medical record number (odd numbers were assigned to music, even numbers assigned to control);  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: DONE;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: DONE;  Groups similar at baseline: demographics‐ DONE;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: DONE (3 patients refused music).	DESCRIPTION: 49 out‐patients undergoing bronchoscopy, USA.  NUMBERS: Music group = 21, Control group = 28.  AGE, mean (SD): Music group = 56 (14), Control group = 54 (17) years old.  GENDER (male/female): Music group = 12/9, Control group = 16/12.  ETHNICITY: not described.  INCLUSION CRITERIA: Bronchoscopy patients; understand English.  EXCLUSION CRITERIA: none stated.	MUSIC GROUP: Played new wave music 'Reflections of Passion' by Yanni, via headphones for the duration of bronchoscopy procedure.  CONTROL GROUP: Standard care.	PHYSIOLOGICAL: Methods of obtaining data unclear. There were no significant differences between groups on any of the physiological parameters.  Oxygen saturation:  Music group = 92 (5)  Control group = 93 (3)  HR:  Music group = 104 (19)  Control group = 101 (22)  BP:  Music group: systolic BP = 154 (27), diastolic BP = 89 (13)  Control group: systolic BP = 152 (24), diastolic BP = 95 (24)  COMFORT: Measured via 'Borg Scale', validity unclear.  MEDICATION INTAKE: Amount of midazolam consumed did not differ between groups.  Music group = 2.81 (1.58) mg  Control group = 3.19 (2.12) mg.
Dzhuraeva 1989	CCT; 2 parallel groups;  Method of allocation: UNCLEAR;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: UNCLEAR;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: UNCLEAR;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 158 inpatients with cardiovascular and respiratory illnesses participating in a therapeutic exercise programme, in the Republic of Uzbekistan.  NUMBERS: unclear how many patients per group. There were 69 cardiovascular patients, and 89 respiratory patients included in the study.  AGE: 30‐55 years old.  GENDER: not described.  ETHNICITY: not described.  INCLUSION CRITERIA: not described.  EXCLUSION CRITERIA: not described.	MUSIC GROUP: Were played classical and pop music during the two week exercise programme.  CONTROL GROUP: Were not played music during the exercise programme.    The exercise programme was tailored to the physical and functional readiness of the participants, with the same protocol applied to both the music and control groups. Respiratory patients received additional training on breathing when stationary and during exercise.	PULSE: Assessed increase in pulse rate during exercise in the first and second weeks of the exercise programme. Method of data collection unclear. In week one, the music group worked harder, as demonstrated by increased pulse.  Cardiovascular patients:  Music group = 50.3 (2.89); Control group = 33.1 (1.54)  Respiratory patients:  Music group = 58.1 (1.66); Control group = 47.2 (1.93)  In week two, the clinical groups showed more similar patterns, and the music group had adapted better to the exercise.  Cardiovascular patients:  Music group = 30.3 (4.12); Control group = 40.5 (3.07)  Respiratory patients:  Music group = 34.1 (2.23); Control group = 43.2 (2.86)  OBSERVATIONS: Complaints, sweating, skin colour, respiration, co‐ordination. Details unclear.  Cardiovascular patients adapted better to the exercise in week one with music, as compared to respiratory patients who showed greater unpleasant reactions, disruptive breathing patterns, and sweating. By the second week of exercise, respiratory patients in the music group were demonstrating better adaptation to exercise than controls.	Authors conclude that cardiovascular patients should use music from the 1st week of exercise, and respiratory patients should use music from the 2nd week of exercise for better adaptation.
Evans 1994	CCT; 2 parallel groups;  Allocated systematically (3 to music group then 1 to control group);  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Power calculation: NOT DONE;  Outcomes obtained for > 80% of participants: DONE;  Groups similar at baseline: Trait anxiety ‐ DONE, other characteristics‐ UNCLEAR;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 24 pre‐operative day surgery patients waiting for surgery under general anaesthesia, in Texas, USA.  NUMBERS: Music group = 18, Control group = 6.  AGE, mean (SD): Music group = 52.67 (11.74), Control group = 43.50 (7.56) years old.  GENDER (male/female): Music group = 8/10, Control group = 1/5.  ETHNICITY: not described.  INCLUSION CRITERIA: Read and speak English; Scheduled for endoscopic cholecystectomy, herniorrhaphy, or appendectomy under general anaesthesia.  EXCLUSION CRITERIA: none described.	MUSIC GROUP: Choice of "easy listening" music selections recorded by the medical staff played via headphones for 20 minutes pre‐operatively.  CONTROL GROUP: Standard care.    Both groups were encouraged to close their eyes or cover them with a cloth.	ANXIETY: Measured via the STAI and a VAS. There was no significant difference between groups on either measure. STAI:  Music group = 33.2  Control group = 34.0  BP: Method of measurement UNCLEAR. There was no significant difference between groups:  Music group: Systolic BP = 125.6 (13.2), Diastolic = 79.8 (12.6)  Control group: Systolic BP = 128.5 (22.7), Diastolic = 74.5 (8.0)  PULSE: Method of measurement UNCLEAR. There was no significant difference between groups:  Music group = 75 (12.8)  Control group = 78 (6.9)
Guétin 2005	CCT; 2 parallel groups;  Allocated by month of admission;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: NOT DONE;  Power calculation: DONE;  Outcomes obtained for >80% of participants: DONE;  Groups similar at baseline: DONE;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: DONE (3 from music group, 2 from control group).	DESCRIPTION: 65 in‐patients undergoing rehabilitation (physiotherapy, balneotherapy, re‐education, and physical exercise) for lower back pain, France.  NUMBERS: Music group = 33, Control group = 32.  AGE: not described.  GENDER (male/female): Music group = 16/17, Control group = 16/16.  ETHNICITY (French/European/African): Music group = 28/2/3, Control group = 28/2/2.  INCLUSION CRITERIA: 30‐70 years old; speak and read French; not cognitively impaired; diagnosis of lower back pain for > 6 months.  EXCLUSION CRITERIA: deafness; epilepsy around auditory stimuli; infectious/inflammatory back pain.	MUSIC GROUP: Music provided for first 4 days of 12 day hospitalisation. Music played for 20 minutes in the afternoon after physical therapy via headphones in a silent room. Patients were given a choice of music, with each choice arranged to have progressive relaxation with re‐awakening period at the end.  CONTROL GROUP: Received physical therapy alone, with no music sessions.	PAIN: Measured via VAS at baseline, day 5, and day 12, plus immediately pre and post therapy sessions. Day 5 outcomes did not significantly differ between groups:  Music group = 3.7 (2.7), Control group = 4.0 (2.0).  DEPRESSION/ANXIETY: Measured via the Hospital Anxiety and Depression (HAD) scale (scores from 0‐21 with higher scores indicating more depression/anxiety). Paper reports the music group had significantly reduced scores from baseline to Day 5 on depression and anxiety when compared to the control group:  Depressoin (change score):  Music group = ‐2.1 (3.0), Control group = 0.6 (2.4)  Anxiety (change score):  Music group = ‐3.5 (3.7), Control group = 2.5 (9.4)  FUNCTIONAL ABILITY: Measure with the Oswestry index (scores from 0‐50 with higher scores indicating more disability). Paper reports that music group had significantly reduced scores from baseline to Day 5 when compared to the control group:  Music group = ‐11.8 (17.8), Control group = ‐2.5 (9.4)
Hamel 2001	CCT; 2 parallel groups;  Allocated via alternation;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: DONE;  Power calculation: DONE;  Outcomes obtained for > 80% of participants: NOT DONE;  Groups similar at baseline: gender‐ DONE, outcomes ‐ NOT DONE;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: DONE (36 left prior to completing the STAI, 2 disliked music, 2 did not want to retake STAI).	DESCRIPTION: 101 in‐patients and out‐patients waiting for cardiac catheterizations in a cardiac telemetry unit, USA.  NUMBERS: Music group = 51, Control group = 50.  AGE, range: 43‐74.  GENDER (male/female): Music group = 34/17, Control group = 29/21.  ETHNICITY: not described.  INCLUSION CRITERIA: Orientated to person, place and time; read and speak English; free of hearing deficit.  EXCLUSION CRITERIA: none stated.	MUSIC GROUP: Listened to 20 minutes of 'Trance‐Zendance' by Halpern. Played via headphones prior to cardiac catheterization.  CONTROL GROUP: Standard care.	ANXIETY: Measured via STAI pre‐ and post‐ 20‐minute intervention period. There was a significant difference in anxiety scores in favour of the music group:  Music group = 37.84 (9.82)  Control group = 44.34 (10.99)  HR: Measured manually by counting heart beats from the radial artery or automatically with a Marquette Component Monitor. There were no significant differences between groups on HR:  Music group = 64.43 (12.00)  Control group = 67.56 (19.43)  BP: Measured via an automatic noninvasive oscillometric cuff, or using a sphygmomanometer auscultating over brachial artery. Paper reports a significant increase in systolic BP in the control group from baseline. There was not a significant difference between groups post‐treatment.  Music group: Systolic BP = 133.53 (19.79), Diastolic BP = 72.78 (10.91)  Control group: Systolic BP = 139.72 (21.61), Diastolic BP = 75.52 (11.94)
Haun 2001	CCT; 2 parallel groups;  Allocated via alternation;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: DONE;  Power calculation: NOT DONE;  Outcomes obtained for >80% of participants: UNCLEAR;  Groups similar at baseline: demographics ‐ DONE, outcomes ‐ UNCLEAR;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 20 pre‐operative patients scheduled for breast biopsy in a holding area in Kentucky, USA.  NUMBERS: 10 patients in each group.  AGE, mean (SD): Music group = 39.7 (13.2), Control group = 37.2 (12.7) years old.  GENDER: 100% female.  ETHNICITY: not described.  INCLUSION CRITERIA: none described.  EXCLUSION CRITERIA: Hearing impairment; history of cancer surgery; hypertension; cardiac disease; pulmonary disease; on medication for any of the above conditions; excluded by attending surgeon.	MUSIC GROUP: Choice from selection of "new age" music listened to via headphones for 20 minutes pre‐operatively. No other music types were offered and patients' preferences were not solicited.  CONTROL GROUP: Standard care.    Family members encouraged to be with both groups once nursing staff had completed all necessary pre‐operative care.	ANXIETY: Measured via the STAI pre‐ and post‐ 20‐minute study period.  Significant difference found in favour of music group:  Music group = 32.8 (7.0)  Control group = 46.6 (9.3)  PHYSIOLOGICAL: BP and HR measured via Spacelab monitor immediately pre‐ and post‐ 20‐minute study period. RR measured via experimenter observation. No differences observed between groups for BP and HR. A significant difference was observed in favour of music group for RR.  BP:  Music group: Systolic BP = 118.0 (14.3), Diastolic BP = 69.0 (10.4)  Control group: Systolic BP = 121.7 (15.9), Diastolic BP = 71.2 (10.6)  HR:  Music group = 77.4 (16.0); Control group = 79.7 (13.6)  RR:  Music group = 16.4 (2.1); Control group = 18.4 (2.1)
Heiser 1997	CCT; 2 parallel groups;  Patients matched for gender and age;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Power calculation: NOT DONE;  Outcomes obtained for >80% of participants: NOT DONE;  Groups similar at baseline: Gender and age‐ DONE, outcome measures‐ UNCLEAR;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: DONE for 15 patients (anaesthesia care providers unable to adhere to the intraoperative anaesthesia study protocol for 6 patients, 8 patients had incomplete data, 1 patient who had denied alcohol abuse preoperatively admitted this postoperatively). A further 9 patients were not included in analysis, presumably due to matched pairing, although this is UNCLEAR.	DESCRIPTION: 34 in‐patients undergoing elective lumbar microdiscectomy procedures consented to participate (although only 10 analysed), Kentucky, USA.  NUMBERS: Music group = 5 patients analysed, Control group = 5 patients analysed.  AGE, mean (range): Original 34 participants = 38 (23‐59) years old.  GENDER (male/female): 21/13.  ETHNICITY: not described.  INCLUSION CRITERIA: ASA status I‐II; scheduled for elective lumbar microdiscectomy procedures.  EXCLUSION CRITERIA: History of substance abuse; psychological disorders; > 40% over ideal body weight; had incurred lumbar spine injuries with other traumatic injuries; history of chronic pain.	MUSIC GROUP: Participants had a choice of 3 cassettes (country, instrumental, classical), with music 60‐80 bpm, played via headphones at a volume pre‐selected by participants. Music began 30 minutes before the end of the surgery and continued without interruption for one hour in PACU.  CONTROL GROUP: Also selected preferred music and checked sound level pre‐operatively, but were not played any music during surgery or in the PACU.	No data reported in paper. The paper reports there were no differences between the two groups on any of the outcome measures.    ANALGESICS: Amount of IV morphine sulfate administered.  PAIN and ANXIETY: Measured via VAS.
Kaempf 1989	CCT; 2 parallel groups;  Allocation by alternative weeks;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: NOT DONE;  Power calculation: NOT DONE;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: UNCLEAR;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 33 out‐patients awaiting arthroscopic procedures in Philadelphia, USA.  NUMBERS: UNCLEAR, paper states that recruitment continued until there were at least 15 patients in each group.  AGE: not described.  GENDER: not described.  ETHNICITY: not described.  INCLUSION CRITERIA: 18 years or older; understand written and verbal instructions.  EXCLUSION CRITERIA: received sedation prior to arriving in the holding area.	MUSIC GROUP: 20 minutes of classical music (tape 3 of Music Rx, developed by Bonny), played via audiocassette played placed 1 foot away during the waiting period.  CONTROL GROUP: Standard care.	BP: Measured via a Dinamap monitor before and after the 20 minute study period. There were no significant differences between the groups. Standard deviations are not provided.  Music group: Systolic BP = 122.3 mm Hg, Diastolic BP = 73.1 mm Hg.  Control group: Systolic BP = 124.6 mm Hg, Diastolic BP = 74.7 mm Hg.  RR: Method of measurement unclear. There was a significant difference in favour of the music group (P = 0.047). No standard deviations provided.  Music group = 15.2  Control group = 19.0  ANXIETY: Measured via STAI before and after intervention period. There was no significant difference between the groups. No standard deviations provided.  Music group = 32.7  Control group = 35.8
Lee 2004b	CCT; 2 parallel groups;  Allocation by day of procedure;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: NOT DONE;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: Physiological measures (DONE), STAI (NOT DONE).  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 113 pre‐operative day patients undergoing cytoscopy, cauterisation, or endoscopy, in China (Hong Kong).NUMBERS: Music group = 58, Control group = 55.AGE, mean (SD): Music group = 50.0 (15.5), Control group = 51.9 (14.4) years old.GENDER (male/female): Music group = 31/27, Control group = 27/28.ETHNICITY: not described.INCLUSION CRITERIA: 18 years or older; undertaking noninvasive day procedures with regional or local anaesthetic.EXCLUSION CRITERIA: Cognitive disability; hearing impairment; received preoperative sedatives; received a colon preparation; pre‐existing co‐morbid illness; did not have sufficient time to participate.	MUSIC GROUP: Choice of eastern and western style easy listening music and Chinese pop music (10 CDs and 10 mini‐discs) played via headphones in reclining chairs for 20‐40 minutes pre‐operatively.CONTROL GROUP: Undertook usual pre‐procedural relaxing activities (e.g. reading, watching TV) in the waiting room.	STATE ANXIETY: Measured via STAI pre‐ and post‐intervention period. Only the music group had a significant drop in anxiety. Post‐intervention scores:Music group = 42.5 (5.7) Control group = 46.4 (6.5) PHYSIOLOGICAL OUTCOMES: Measured via "standard non‐invasive instruments" pre‐ and post‐intervention period. There were no significant differences between groups.BP scores: Music group: Systolic BP = 124.2 (21.1), Diastolic BP = 70.0 (10.8) Control group: Systolic BP = 129.4 (25.6), Diastolic BP = 72.0 (11.1) PULSE scores: Music group = 71.1 (10.4) Control group = 70.1 (8.6) RR:Music group = 16.6 (1.0) Control group = 16.7 (1.0)
Metera 1975a	CCT; 2 groups (non‐parallel), intervention group was cross‐over (2 types of music played in same order for all participants), control group may have been recruited post‐hoc (UNCLEAR).  Allocation method: Participants appear to have been recruited to intervention group first, and control participants recruited after‐ UNCLEAR.  Blinding of group allocation: NOT DONE  Blinded assessment of outcomes: UNCLEAR if automated;  Power calculation: UNCLEAR;  Outcomes obtained for >80% of participants: UNCLEAR;  Groups similar at baseline: UNCLEAR;  Protection against contamination: NOT DONE‐ cross‐over in music group. DONE for control group.  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 45 patients with disease of the lungs or chest being treated at the Department of Chest Surgery in Zakopane, Poland.  NUMBERS: Music group = 30, Control group = 15.  AGE, mean (range): Music group = 34 (19‐62) years old, Control group not described.  GENDER (male/female): Music group = 25/5, Control group not described.  ETHNICITY: not described.  INCLUSION CRITERIA: not described.  EXCLUSION CRITERIA: not described.	MUSIC GROUP: Cross‐over study. Music was played via headphones. Patients were played Debussy's 3rd part of Bergamasque Suite (Clair de Lune) on the piano (soothing music), and then Bartok's Wonderful Mandarin (nerve racking/exciting music). First, there was a 3‐minute rest in the recumbent position then, before, in between, and after each musical piece was a 3‐minute pause.  CONTROL GROUP: Received no music.  No specific treatment/surgery was being given to any participants during the experiment.	Parameters were measured at 5 time points in the music group: 1) Following 3‐min rest; 2) Following soothing music; 3) Following 3‐min pause; 4) Following exciting music; 5) Following 3‐min pause. Parameters were measured at 4‐time points in the control group (to follow same time scale as the music group)‐ a final 5th measurement was not taken for the control group.  Paper states "No statistically significant differences were found in any of these parameters between the experimental and the control group".  RESPIRATORY RATE: No significant differences within the music group.  TIDAL VOLUME: Within the music group there was significant differences between the 1st and 2nd measurements (639 ml and 527 ml) only.  MINUTE VENTILATION: Within the music group there was a significant difference (P <0.1) [sic] between the 1st and 2nd measurements (11l and 8.9l). Measurements during exciting music showed a rise in MV almost to the initial value (4th measurement = 10.6l).  MINUTE OXYGEN CONSUMPTION: Within the music group there was a significant decrease between the 1st and 2nd measurements (315 ml and 282 ml). There was an increase of 60 ml during the exciting music (significance unclear).  BASAL METABOLIC RATE: Within the music group there was a significant decrease between the 1st and 2nd measurements (42% and 24 %). Exciting music increased BMR to 53.5% ("significant even at P < 0.1" [sic]).  HEART RATE: No significant differences within the music group.	Data not sufficient for extraction. No SDs reported. Paper reports significance as P < 0.1.  Data for control group reported in line graphs only.
Metera 1975b	CCT; 2 groups (non‐parallel), intervention group was cross‐over (2 types of music played in same order for all participants), control group may have been recruited post‐hoc (UNCLEAR).  Allocation method: Participants appear to have been recruited to intervention group first, and control participants recruited after‐ UNCLEAR.  Blinding of group allocation: NOT DONE  Blinded assessment of outcomes: UNCLEAR if automated;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: UNCLEAR;  Protection against contamination: NOT DONE‐ cross‐over in music group. DONE for control group.  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 45 patients with disease of the lungs or chest being treated at the Department of Chest Surgery in Zakopane, Poland.  NUMBERS: Music group = 30, Control group = 15.  AGE, mean: Music group = 34 years old, Control group not described.  GENDER (male/female): Music group = 25/5, Control group not described.  ETHNICITY: not described.  INCLUSION CRITERIA: not described.  EXCLUSION CRITERIA: not described.	MUSIC GROUP: Cross‐over study. Music was played via headphones. Patients were played Debussy's 3rd part of Bergamasque Suite (Clair de Lune) on the piano (soothing music), and then Bartok's finale of the Wonderful Mandarin (nerve racking/exciting music). First there was a 3‐minute rest in the recumbent position, then a 3‐minute pause before the first musical piece. After the first piece of music, there was a 4‐minute pause before the second musical piece was played.  CONTROL GROUP: Received no music.  No specific treatment/surgery was being given to the patients during the experiment.	Parameters of airway resistance were measured at three time points in both groups: 1) Following 3‐min rest; 2) Following relaxing music; 3) Following exciting music.    AIRWAY RESISTANCE:  Tests were carried out using a Godart Pulmotest. The maximum forced one‐second expiration curve, maximum mid‐expiratory flow rate, first phase of forced expiratory volume, and the inspiration/expiration time ratio, were analysed.    There were no significant differences between the control and music group.    There were no significant differences between conditions within the music group.	Data not sufficient for extraction.    Appears to be same participants in Metera 1975a (mean age and gender distribution of music group is the same).
Mok 2003	CCT; 2 parallel groups;  Allocated by alternation (weeks)  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: Physiological outcomes (DONE‐ automated), C‐STAI (NOT DONE);  Unit of allocation same as unit of analysis: NOT DONE;  Power calculation: DONE;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: DONE;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 80 patients undergoing minor surgery in a day‐surgery ward in China.  NUMBERS: 40 patients per group.  AGE, range: 18‐70.  GENDER, (male/female): Music group = 7/33, Control group = 8/32.  ETHNICITY: not described.  INCLUSION CRITERIA: 18 years or older; consenting; comprehend written and oral instruction.  EXCLUSION CRITERIA: hearing impairment; received preoperative sedative; cardiac disease; history of hypertension.	MUSIC GROUP: Choice of 3 types of music with slow rhythms: classical music (concertos and sonatas), contemporary popular music (e.g. "The heart will go on"), Chinese popular music (e.g. "Night plane"). Music had 45 minutes running time and played via headphones for duration of surgery.  CONTROL GROUP: Standard care.	ANXIETY: measured via C‐STAI post‐surgery. Patients were asked to fill out the questionnaire by thinking retrospectively over procedure.  Mean difference = ‐25.40, 95% CI = ‐29.28, ‐21.52  Music group = 31.83 (4.97)  Control group = 57.23 (11.50)    PHYSIOLOGICAL MEASURES: HR and BP measured via an automated portable HR monitor. Music group had 3 intra‐operative readings taken and the paper reports the mean scores, the control group readings taken post‐operatively only. Data not suitable for comparison.
Moss 1987	CCT; 2 parallel groups;  Allocation method UNCLEAR ("groups were divided by gender and chosen by convenience");  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: DONE;  Power calculation: NOT DONE;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: DONE;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 17 day‐patients undergoing arthroscopic surgery, USA.  NUMBERS: Music group = 9, Control group = 8 patients.  AGE: 20‐40 years old.  GENDER: not described.  ETHNICITY: not described.  INCLUSION CRITERIA: admitted for scheduled arthroscopic surgery under general anaesthesia.  EXCLUSION CRITERIA: none stated.	MUSIC GROUP: Choice of 4 musical tapes (classical tapes from 'Music Rx', Bonny; popular tapes from 'Music Rx'; New Age tape by Steven Halpern called "Dawn"; easy listening selections assembled by investigator). Music played via headset and auto‐reverse cassette player. From administration of pre‐operative medication to PACU. Participants were told to restart the music if they desired after their return to the ambulatory surgery unit.  CONTROL GROUP: standard care.	ANXIETY: state anxiety measured via STAI approximately 2 hours post‐operatively. Non‐significant.  Music group = 32.60 (8.73)  Control group = 29.80 (8.73)	SDs are estimated from the t‐value.
Schuster 1985	CCT; 2 parallel groups;  Allocation method: UNCLEAR;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: UNCLEAR if data collection procedure automated.  Unit of allocation same as unit of analysis: UNCLEAR;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: NOT DONE: BP.  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 63 patients undergoing dialysis, Florida, USA.  NUMBERS: Music group = 31, Control group = 32.  AGE (range): 22‐81 years old.  GENDER (male/female): 24/39.  ETHNICITY: not described.  INCLUSION CRITERIA: not described.  EXCLUSION CRITERIA: not described.	MUSIC GROUP: Choice of classical, pop, rock, jazz, country/western, gospel, easy listening, swing, and bluegrass played via headphones during dialysis treatment. Music was played for 1 hour beginning 30 minutes after the onset of dialysis treatment, there then was an hour of no music, followed by another hour of music.  CONTROL GROUP: Standard care.	BP: Measured after each hour of dialysis treatment. BP was recorded daily from each patient's chart for a 2‐week baseline period and a 3‐week treatment period. The two groups did not significantly differ on systolic and diastolic BP readings for onset through final readings during the treatment period.  NURSE RATINGS: Not validated.  ATTITUDE SURVEY: Not validated.	Data not sufficient for extraction.
Staricoff 2003b	CCT; 2 parallel groups;  Allocation method: UNCLEAR;  Blinding of group allocation: UNCLEAR (this is one of a series of studies. It states at beginning of document that blinding was carried out where possible but unclear where or how this was achieved).  Blinded assessment of outcomes: UNCLEAR;  Unit of allocation same as unit analysis: UNCLEAR;  Power calculation: NOT DONE;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: UNCLEAR;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 88 pregnant women attending a high‐risk antenatal clinic, London, UK.  NUMBERS: Music group = 54, Control group = 34.  AGE: not described.  GENDER: 100% female.  ETHNICITY: not described.  INCLUSION CRITERIA: not described.  EXCLUSION CRITERIA: not described.	MUSIC GROUP: One or two musicians playing in one corner of the waiting room with the chairs arranged in a semi‐circle around them. Harp, clarinet, or guitar were preferred, violin and cello not welcomed. Does not explain in depth what was played.  CONTROL GROUP: No live music.	BP: Obtained by the clinician (method unclear) at the beginning of the consultation (after the waiting room experience). There was no significant difference between the groups.  Systolic BP:  Live music (n = 54), mean (SD) = 115 (13)  Control group (n = 34) mean (SD) = 118 (16)  Diastolic BP:  Live music = 70 (11)  Control group = 72 (11)	This is one of a series of studies. Two more studies were conducted in the antenatal clinic that do not need inclusion criteria for the review due to the study design (before and after).
Szeto 1999	CCT; 2 parallel groups;  Allocation method UNCLEAR ("a quasi‐experimental design was used");  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: DONE;  Power calculation: NOT DONE;  Outcomes obtained for > 80% of participants: NOT DONE;  Groups similar at baseline: DONE;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: DONE (3 control participants could not compete procedure as sent for their operation).	DESCRIPTION: 9 in‐patients waiting for elective surgery in a theatre holding area, China.  NUMBERS: Music group = 6, Control group = 3.  AGE, mean (range): 58 (21‐89).  GENDER: not described.  ETHNICITY: 100% Chinese  INCLUSION CRITERIA: 18 years or older; understand written and verbal instructions; no hearing impairment; not received any pre‐medication sedation; consented to participate.  EXCLUSION CRITERIA: none described.	MUSIC GROUP: Choice of: slow rhythmical songs; Chinese slow rhythmical music; Western slow rhythmical music. Played via headphones for 20 minutes pre‐operatively.  CONTROL GROUP: Standard care.	BP: Measured via a calibrated Dinamap BP monitor before and after 20 minute study period. No significant differences between groups.  Music group (N = 6): Systolic BP = 143.83 (31.25), Diastolic BP = 80.83 (9.07).  Control group (N = 3): Systolic BP = 144.00 (16.09), Diastolic BP = 75.33 (7.02).  ANXIETY: Measured via C‐STAI pre‐ and post‐treatment. Paper reports a significant difference (Wilcoxon Signed‐Rank test) in favour of the music group after the 20 minute study period.  Music group (N = 6) = 33.33 (6.38)  Control group (N = 3) = 46.33 (4.73)  TENSION: Measured via the Subjective Unit of Tension Scale (a NRS) pre‐ and post‐treatment. No significant differences between groups.  Music group (N=6) = 1.67 (1.63)  Control group (N=3) = 3.00 (2.00)
Tanabe 2001	CCT; 3 parallel groups;  Allocation method: alternation;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: DONE;  Power calculation: DONE;  Outcomes obtained for > 80% of participants: DONE;  Groups similar at baseline: Pain‐ DONE, demographics‐ UNCLEAR;  Protection against contamination: NOT DONE;  Description of withdrawals and drop‐outs: DONE (75 exclusions detailed).	DESCRIPTION: 76 patients presenting to an emergency department with minor musculoskeletal trauma, in Midwest USA.  NUMBERS: Music group = 24, Standard Care = 28, Ibuprofen = 24 (excluded from review).  AGE mean (SD): 41 (17.54) years old.  GENDER: not described.  ETHNICITY: not described.  INCLUSION CRITERIA: 18 years or older; chief complaint of minor extremity trauma distal to and including the knee or elbow.  EXCLUSION CRITERIA: analgesics administered prior to arrival; injury occurred more than 24 hours earlier; pain rating 3 or less; unable to speak English; unable to use pain scales; lacerations; sensitivity to cold; Raynaud's phenomenon; rheumatoid arthritis to the affected joint.	MUSIC GROUP: Provided with a Walkman tape player and choice of music (classical, country, rock, pop, and jazz), or were allowed to listen to the radio if they preferred. Patients also received standard care.  STANDARD CARE: Consisted of ide, elevation, and immobilization of the affected extremity.  IBUPROFEN: Excluded from review.	PAIN: Pain intensity measured at 0, 30, and 60 minutes via 10‐point NRS. There was no statistical differences between groups at any time interval. All groups showed significant improvement from baseline.  Mean pain ratings:  Music group: 0 min = 6.46; 30 min = 5.75; 60 min = 5.83  Standard care: 0 min = 6.57, 30 min = 5.61; 60 min = 5.57    SATISFACTION: Measured via VRS and a non‐validated yes/no question. There were no differences between groups on either measure.	No SDs provided.
Tse 2005	CCT; 2 parallel groups;  Allocation method: Mondays = experimental group, Thursdays = control group.  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: NOT DONE;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: DONE;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 57 post‐operative in‐patients who have undergone elective nasal surgery.  NUMBERS: Music group = 27, Control group = 30.  AGE, mean (SD): Music group = 39.2 (14.4), Control group = 40.6 (14.5).  GENDER (male/female): Music group = 11/16, Control group = 13/17.  ETHNICITY: 100% Chinese.  INCLUSION CRITERIA: scheduled for functional endoscopic sinus surgery or turbinectomy.  EXCLUSION CRITERIA: History of mental disturbance; had undergone previous major surgery; opioid dependent; hearing problem; history of hypertension.	MUSIC GROUP: Choice of Chinese and Western various music types and patients encouraged to bring music of their own choice. Listened for 30 minutes on four occasions: post‐operatively (T1), again 4 hours later (T2), on the first post‐operative day at 8am (T3) and again at noon (T4).  CONTROL GROUP: Standard care.	PAIN: Measured via VRS at baseline and after each intervention session. Music group gave significantly lower pain ratings at all four time points. T4 data:  Music group = 1.04 (0.28)  Control group = 4.07 (0.33).  SYSTOLIC BP: Measurement method unclear. Significant differences at all four time points in favour of music group. T4 data:  Music group = 113.67 (11.28) mm Hg  Control group = 132.37 (18.68) mm Hg  HR: Measurement method unclear. Significant differences at all four time points in favour of music group. T4 data:  Music group = 74.52 (5.99) bpm  Control group = 81.57 (7.61) bpm  PAIN MEDICATION: Number of paracetamol tablets taken, and dose of diclofenac sodium was recorded four hours after surgery and at 8am on the first post‐operative day. Significant differences were found in favour of the music group at both time points for paracetamol intake, and at the first time point only for diclofenac sodium intake. 8am on first post‐operative day data:  Music group: Paracetamol intake = 2.15 (2.41) tablets, Diclofenac Sodium = 0.04 (0.19).  Control group: Paracetamol intake = 5.43 (2.00), Diclofenac Sodium = 0.20 (0.41).
Williamson 1992	CCT; 2 parallel groups;  Method of allocation: alternation;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: DONE;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: demographics‐ DONE;  Protection against contamination: DONE;  Description of withdrawals and dropouts: DONE (4 patients refused to listen to ocean sounds after first night).	DESCRIPTION: 60 post‐operative in‐patients after coronary artery bypass graft in a progressive care area, USA.  NUMBERS: 30 patients per group.  AGE, mean (SD): Sounds = 58.6 (7.72), Control group = 58.3 (9.31) years old.  GENDER (male/female): Sounds = 21/9, Control group = 24/6.  ETHNICITY: not described.  INCLUSION CRITERIA: presenting for elective coronary artery bypass graft surgery; 21‐69 years old; were not retained in the ICU for longer than 3 days after surgery; did not have to return to surgery; were not placed on the intra‐aortic balloon pump; did not receive any surgery other than bypass grafting.  EXCLUSION CRITERIA: Documented sleep disorder; were having repeat coronary artery bypass graft surgery; taking tricyclic antidepressants regularly within 1 month of surgery; could not hear sounds played softly at bedside; experimental group participants did not complete 3 nights of listening to ocean sounds; chest pleural tube in place beyond the 2nd night post‐transfer to progressive care unit.	SOUNDS GROUP: Marsona Sound Conditioner (providing white noise in the form of rain, ocean waves, or a waterfall). 56/60 patients chose ocean sounds. Sounds were played at the bedside throughout the night (switched on between 20.30 and 21.00 hours). Sounds played for 3 nights.  CONTROL GROUP: No sounds.	SLEEP: Pre‐test evaluated for patients on their usual sleep at home, data collected on admission, prior to surgery. Assessed on the fourth day post‐transfer for the quality of sleep the previous night. Measured via the Richards‐Campbell Sleep Questionnaire, which includes VAS for sleep depth, latency to sleep onset, awakening, return to sleep, quality of sleep, and a total sleep score. No SDs reported.  The sound group reported significantly deeper sleep than controls:  Sound group: Pre‐test = 49, Post‐test = 56  Control group: Pre‐test = 66, Post‐test = 35  There was no significant difference between groups in falling asleep:  Sound group: Pre‐test = 68, Post‐test = 71  Control group: Pre‐test = 62, Post‐test = 60  The sounds group reported being awake significantly less in the night:  Sound group: Pre‐test = 68, Post‐test = 65  Control group: Pre‐test = 69, Post‐test = 51  The sounds group returned to sleep significantly faster than controls:  Sound group: Pre‐test = 63, Post‐test = 68  Control group: Pre‐test = 61, Post‐test = 51  The sounds group reported significantly better quality of sleep than controls:  Sounds group: Pre‐test = 71, Post‐test = 69  Control group: Pre‐test = 67, Post‐test = 46  The total sleep score was significantly better in the sound group:  Sounds group: Pre‐test = 64, Post‐test = 66  Control group: Pre‐test = 65, Post‐test = 48
Wolowicka 1989	CCT; 2 parallel groups;  Allocation method: UNCLEAR;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: UNCLEAR;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: UNCLEAR;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 50 patients undergoing surgery with local anaesthetic, Poland.  NUMBERS: Music group = 30, Control group = 20.  AGE: not described.  GENDER: not described.  ETHNICITY: not described.  INCLUSION CRITERIA: none described.  EXCLUSION CRITERIA: none described.	MUSIC GROUP: Played music before during and after surgery. Patients chose music from a selection of instrumental tapes (music was soft, bright, avoiding high‐pitched sounds, classical).  CONTROL GROUP: Standard care.	ANXIETY: Measured via STAI the day before and directly after surgery in the recovery room.  Music group: pre‐surgery = 38, post‐surgery = 36.  Control group: pre‐surgery = 46, post‐surgery = 43.  On the second and third day after surgery anxiety was lower in the music group. No statistical analyses reported.	Data not in sufficient detail for extraction.
Yamanaka 2003	CCT; 2 parallel groups;  Allocation method: Day of week;  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: NOT DONE;  Unit of allocation same as unit of analysis: NOT DONE;  Power calculation: UNCLEAR;  Outcomes obtained for > 80% of participants: UNCLEAR;  Groups similar at baseline: UNCLEAR;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: NOT DONE.	DESCRIPTION: 57 in‐patients undergoing surgery with local anaesthetic, Japan.  NUMBER: Music group = 34, Control group = 23.  AGE, mean (range): Music group = 45.3 (18‐75), Control group = 38.2 (15‐79) years old.  GENDER (male/female): Music group = 12/22, Control group = 6/17.  ETHNICITY: not described.  INCLUSION CRITERIA: Consenting participants during the period May to July.  EXCLUSION CRITERIA: none described.	MUSIC GROUP: Were played a set piece (by Elgar) from when they entered the theatre to the end of surgery.  CONTROL GROUP: Standard care.	ANXIETY: Measured via STAI before and after surgery. Participants were requested to think back to how they felt during surgery in the post‐treatment questionnaire.    Authors group findings into those who demonstrated a reduction in anxiety (from pre to post), those who showed no change, and those who showed an increase in anxiety. They then used Chi‐square to assess the differences between music and control groups. This analysis showed no difference between groups.
Yung 2002	CCT; 3 parallel groups;  Allocation method: UNCLEAR, paper states it was a quasi‐experimental design.  Blinding of group allocation: NOT DONE;  Blinded assessment of outcomes: Anxiety‐ NOT DONE, BP and HR‐ automated;  Unit of allocation same as unit of analysis: DONE;  Power calculation: NOT DONE;  Outcomes obtained for > 80% of participants: DONE;  Groups similar at baseline: DONE;  Protection against contamination: DONE;  Description of withdrawals and drop‐outs: DONE (description of 12 exclusions and no withdrawals).	DESCRIPTION: 30 pre‐operative patients waiting for transurethral resection of the prostate, in a theatre holding area, Hong Kong, China.  NUMBERS: 10 patients in each group.  AGE, mean (SD): Music group = 65.2 (10.15), Control group = 70.9 (6.49).  GENDER: 100% male.  ETHNICITY: 100% Chinese.  INCLUSION CRITERIA: Comprehend oral and written instructions.  EXCLUSION CRITERIA: Cardiac disease; history of hypertension; received pre‐operative sedation.	MUSIC GROUP: 20 minutes of slow rhythm soft music played pre‐operatively via headphones. Choice of three tapes that had been judged by a panel of 3 musicians (slow rhythm songs, Chinese slow rhythm music, Western slow rhythm music). No nurse presence.  CONTROL GROUP: No nurse or music present.  NURSE PRESENCE: Excluded from review.	PHYSIOLOGICAL: BP and HR recorded on an automated BP monitor (Dinamap 1846‐SX) before and after 20 minute study period. Paper reports no significant differences between groups (Kruskal‐Wallis test)  BP:  Music group: Systolic BP = 126.5 (18.03), Diastolic BP = 73.9 (10.83)  Control group: Systolic BP = 138.8 (19.61), Diastolic BP = 81.0 (10.71)  HR:  Music group = 72.2 (12.32)  Control group = 79.3 (11.26)  ANXIETY: Measured via the C‐STAI before and after 20 minute study period. Paper reports no significant differences between groups (Kruskal‐Wallis test):  Music group = 37.6 (7.41)  Control group = 37.7 (7.27)

Study ID	Methods	Participants	Interventions	Outcomes
Donald 2000	RCT; 2 x 2 design (2 x flooring, 2 x therapy).	DESCRIPTION: 54 in‐patients in an elderly care rehabilitation ward, in England.  NUMBERS: Linoleum floor = 26, Carpeted floor = 28.  AGE, mean: Linoleum floor = 82.75, Carpeted floor = 83.20  GENDER (male/female): Linoleum floor = 8/18, Carpeted floor = 2/26.  ETHNICITY: not described.  INCLUSION CRITERIA: All patients admitted for rehabilitation.  EXCLUSION CRITERIA: none described.	LINOLEUM FLOOR: Patient admitted to one of two four‐bed bays with latex vinyl square tile flooring.  CARPETED FLOOR: Patient admitted to one of two four‐bed bays with hospital‐duty flotex (Flotex® 200). This carpet was chosen because it has no pile facilitating bacterial build‐up; it also reduces the movement of equipment satisfactorily when the brakes are applied, but still enables easy wheeling of beds, chairs and commodes.    Patients were also allocated to either routine physiotherapy or additional exercises (stratified by flooring type). Outcomes relating to these groups are excluded from the review.	NUMBER OF FALLERS: obtained from the accident report forms.  NUMBER OF FALLS: obtained from the accident report forms.  INDEPENDENCE: obtained from the Barthel index.  LENGTH OF STAY: not enough data for extraction, no difference reported between groups.
Willmott 1986	RCT, cross‐over design, 2 conditions.	DESCRIPTION: 58 elderly hospital patients in England.  NUMBERS: 58 patients (cross‐over)  AGE: mean = 76.05 years old.  GENDER: not described.  ETHNICITY: not described.  INCLUSION CRITERIA: not described.  EXCLUSION CRITERIA: not described.	CARPETED CORRIDOR: Each patient walked along the corridor towards a staff member standing 15 m ahead. Chalk marks were drawn at an interval of 10 m.  REFLECTIVE VINYL TILED CORRIDOR: Each patient walked along the corridor towards a staff member standing 15 m ahead. Chalk marks were drawn at an interval of 10 m.	GAIT SPEED and STEP LENGTH: The number of steps taken was counted from the time the patient crossed the first chalk line until the distal line was crossed by the leading forefoot, and elapsed time was measured by a stopwatch.    Patient specific differences not reported. Study reports significant differences on both outcomes in favour of the carpeted floor.    Gait speed (m/s):  Carpet = 0.48 (0.19), Vinyl = 0.40 (0.17)    Step length (cm):  Carpet = 33.72 (12.01), Vinyl = 29.50 (12.32)

Study ID	Reason for exclusion
Berg 2001	Participants (students)
Hagerman 2005	Study design

Study ID	Reason for exclusion
Anderson 1982	Paediatric hospital
Buemi 1995	Study design; outcomes
Cheek 1971	Qualitative
Hewawasam 1996	Study design
Hussian 1987	Study design
Skoutelis 1993	Study design
Thorne 1963	Qualitative evaluation

Study ID	Reason for exclusion
Baldwin 1985	Outcomes and policy changes
Beldon 2002	Other systematic review in this area (Cullum 2008)
Cooper 1998	Other systematic review in this area (Cullum 2008)
Davies 1980	Study design
Dubbs 2003	Not a research study
Gray 2000	Other systematic review in this area (Cullum 2008)
Grindley 1996	Other systematic review in this area (Cullum 2008)
Hanger 1999	Study design
Holahan 1972	Test (not clinical) situation, policy change
Larsson 1991	Study design
Mayer 1991	Study design‐ inappropriate data
Nixon 2006	Other systematic review in this area (Cullum 2008)
Okada 1986	Not health‐related outcomes
Peterson 1977	Outcomes (validity and relevance)
Pring 1998	Other systematic review in this area (Cullum 2008)
Schott 1999	Policy change
Sommer 1958	Study design
Sherertz 1985	Intervention
Williams 1962	Policy changes with cleaning of blankets

Study ID	Reason for exclusion
Aaron 1996	No intervention‐ observational study
Baker 1987	No intervention
Baker 1992	No intervention
Baker 1993a	No intervention
Baker 1993b	Review article
Bame 1995	Study design
Biley 1994	Review article
Buemi 1995	Study design; outcomes
Falk 1973	No intervention
Gabor 2003	No intervention in patients
Gast 1989	Study design
Grumet 1994	Discussion article
Haddock 1994	Study design
Harrison 1989	Study design
Haslam 1970	Study design
Hilton 1976	Study design
Hilton 1985	No intervention
Kam 1994	Review article
Lamont 1975	No intervention
Lan‐Ping 2000	Policy confound
Moore 1998	Policy change
Pimentel‐Souza 1996	Study design (cross‐sectional, no intervention)
Yinnon 1992	Study design

Study ID	Reason for exclusion
Beauchemin 1996	Retrospective study
Beauchemin 1998a	Duplicate of Beauchemin 1998b
Beauchemin 1998b	Retrospective study
Benedetti 2001	Retrospective study
Diffey 1988	Study design
Fox 1986	Study design
Harrison 1989	Study design
Kolanowski 1990	Setting
Rosenthal 1985	Intervention
Satlin 1992	Intervention
Sheperd 2001	Study design
Van Someren 1997	Setting; Study design
Veitch 2001	Literature review

Study ID	Reason for exclusion
Gaffney 1986	Setting; study design
Nelson Negley 1990	Setting; outcomes
Tideiksaar 1993	Intervention

Study ID	Reason for exclusion
Ansari 1969	Study design
Hashiguchi 2005	Study design
Morris 1970	Study design
Plourde 1997	Intervention‐ temperature of equipment not ambient room temperature
Wyon 1968	Staff outcomes

Study ID	Reason for exclusion
Butler 1993	Setting
Carpman 1983	Study design
Dickinson 1995	Setting
Mayer 1991	Study design‐ inappropriate data
Passini 1998	No intervention; comparison with healthy controls
Watanabe 1997	Not health‐related outcomes; conversation confounding
Weisman 1981	Setting
Wright 1993	Participants not patients

Study ID	Reason for exclusion
Keep 1980	Study design
Verderber 1983	Study design, validity of outcomes
Wilson 1972	Study design‐ retrospective

Study ID	Reason for exclusion
Alvermann 1979	Descriptive article
Anthony Williams	Descriptive article
Bame 1993	Study design
Barker 2005	Descriptive article
Berlet 1979	No intervention
Birdsong 1990	No intervention
Christenfeld 1989	CBA‐ Control sites and 'before' sites not clearly defined
Connell 1996	Review article
Coulson 1997	Setting
Counsell 2000	Policy confound
Covinsky 1998	Policy confound
Davidson 1971	Study design
Dennis 1988	Descriptive article
Devlin 1992	Study design
Donchin 2002	Review article
Dracup 1988	Review article
Freeman 1987	Study design
Greenberg 1992	Descriptive article
Gurr 1997	Descriptive case study
Hahn 1995	Study design
Harvey 1998	Review article
Harwood 1992	Study design
Holahan 1973	Outcomes
Holahan 1976	Outcomes
Hyde 1989	Qualitative; setting
Ingham 1997	Setting
Jastremski 1998	Literature review
Kovach 1997	Setting
Laitinen 1994	Intervention
Lawson 2000	Study design (same study as Lawson 2003)
Lawson 2002	Study design (same study as Lawson 2003)
Lawson 2003	Study design (before‐and‐after no contemporaneous control)
Lawton 1970	Study design
Leather 2003	Study design (before‐and‐after no contemporaneous control)
Liebowitz 1979	Study design
Martin 1998	Policy confound
McLaughlin 1976	Qualitative study
McGonagle 2002	Study design
McNaughton 2005	Study design
Meyer 1994	No intervention
Middelboe 2001	Confounding
Noskin 2001	Literature review
Notelovitz 1978	Study design
Oberle 1990	Study design
Okamoto 2002	Study design
Olsen 1984	Outcomes; unclear study design
Palmer 1998	Policy confound
Pattison 1996	Confounding staffing differences
Rubin 1998	Literature review
Rudy 1995	Intervention (care delivery systems)
Shirani 1986	Study design
Smith 1974	Follow‐up study (Smylie 1971, Davidson 1971); study design
Smylie 1971	Study design
Stahler 1984	Study design (gender differences)
Swan 2003	Study design
Tyerman 1980	Unclear intervention/control
Vietri 2004	Study design
Walker 1989	Qualitative interviews
Weber 1996	Overview article
Whitehead 1984	Study design
Winkel 1986	Descriptive case studies

PERMALINK

Sensory environment on health‐related outcomes of hospital patients

Amy Drahota

Derek Ward

Heather Mackenzie

Rebecca Stores

Bernie Higgins

Diane Gal

Taraneh P Dean

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Background

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Types of outcome measures

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

1.

Data extraction and management

Assessment of risk of bias in included studies

Data synthesis

Subgroup analysis and investigation of heterogeneity

Results

Description of studies

Studies awaiting assessment

Risk of bias in included studies

2.

Effects of interventions

Providing positive distracters

Aromas

Description of studies on aromas:

1. Aromas: Characteristics of included studies.

2. Aromas: Characteristics of excluded studies.

Risk of bias in included studies on aromas:

Findings from studies on aromas:

Anxiety

Other outcomes

Findings from non‐randomised studies:

Art

Description of studies on art:

3. Art: Characteristics of excluded studies.

Audiovisual distractions

Description of studies on audiovisual distractions:

4. Audiovisual: Characteristics of included studies.

5. Audiovisual: Characteristics of excluded studies.

Risk of bias in included studies on audiovisual distractions:

Findings from studies on audiovisual distraction versus audio distraction (music):

Anxiety

1.1. Analysis.

Exploring the heterogeneity of studies on anxiety:

Pain

1.2. Analysis.

Exploring the heterogeneity of studies on pain:

Heart rate

Studies with insufficient data for extraction:

Blood pressure

Studies with insufficient data for extraction:

Other outcomes

Findings from studies on audiovisual distraction versus scheduled rest:

Anxiety

Pain

Heart rate

Studies with insufficient data for extraction:

Date	Event	Description
20 October 2008	Amended	Converted to new review format.
30 November 2004	New citation required and conclusions have changed	Substantive amendment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Anxiety	2	87	Std. Mean Difference (IV, Random, 95% CI)	‐0.24 [‐1.05, 0.56]
2 Pain	2		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected
2.1 Endoscopic procedural pain	1		Std. Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 post‐operative pain	1		Std. Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Anxiety	10		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
1.1 Pre‐procedural anxiety	4	361	Std. Mean Difference (IV, Random, 95% CI)	‐0.82 [‐1.03, ‐0.60]
1.2 Procedural anxiety	3	183	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.47, 0.23]
1.3 Post‐operative anxiety	3	220	Std. Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.52, 0.44]
1.4 ICU anxiety	1	64	Std. Mean Difference (IV, Random, 95% CI)	0.17 [‐0.32, 0.66]
2 Heart rate	8	543	Mean Difference (IV, Random, 95% CI)	0.40 [‐1.02, 1.82]
3 Blood pressure	8		Mean Difference (IV, Random, 95% CI)	Subtotals only
3.1 Systolic	7	533	Mean Difference (IV, Random, 95% CI)	‐0.40 [‐2.48, 1.67]
3.2 Diastolic	6	478	Mean Difference (IV, Random, 95% CI)	‐0.35 [‐2.08, 1.39]
3.3 Arterial	1	30	Mean Difference (IV, Random, 95% CI)	4.0 [‐5.33, 13.33]
4 Respiration rate: with choice of outcomes	2		Mean Difference (IV, Random, 95% CI)	Subtotals only
4.1 Post‐operative period for Ikonomidou 2004 and final scores (both studies)	2	119	Mean Difference (IV, Random, 95% CI)	‐1.72 [‐1.00, ‐0.44]
4.2 Post‐operative period for Ikonomidou 2004 and change score for Lee 2005	2	119	Mean Difference (IV, Random, 95% CI)	‐2.48 [‐3.85, ‐1.11]
4.3 Pre‐operative period for Ikonomidou 2004 and final scores (both studies)	2	119	Mean Difference (IV, Random, 95% CI)	‐0.92 [‐1.92, 0.09]
4.4 Pre‐operative period for Ikonomidou 2004 and change scores for Lee 2005	2	119	Mean Difference (IV, Random, 95% CI)	‐2.09 [‐4.51, 0.34]
5 Skin conductance	2		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected
6 Stress hormones	3		Std. Mean Difference (IV, Random, 95% CI)	Subtotals only
6.1 Cortisol	3	216	Std. Mean Difference (IV, Random, 95% CI)	‐0.32 [‐0.73, 0.09]
6.2 Epinephrine	2	123	Std. Mean Difference (IV, Random, 95% CI)	‐0.02 [‐0.38, 0.33]
6.3 Norepinephrine	2	123	Std. Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.44, 0.27]
6.4 Adrenocorticotropic hormone (ACTH)	1	30	Std. Mean Difference (IV, Random, 95% CI)	‐0.44 [‐1.17, 0.28]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Anxiety	29	1812	Std. Mean Difference (IV, Random, 95% CI)	‐0.55 [‐0.74, ‐0.36]
1.1 Pre‐procedural anxiety	9	744	Std. Mean Difference (IV, Random, 95% CI)	‐0.37 [‐0.62, ‐0.12]
1.2 Procedural anxiety	15	865	Std. Mean Difference (IV, Random, 95% CI)	‐0.69 [‐1.02, ‐0.36]
1.3 ICU/post‐operative anxiety	5	203	Std. Mean Difference (IV, Random, 95% CI)	‐0.58 [‐1.01, ‐0.15]
2 Heart rate	21	1653	Mean Difference (IV, Random, 95% CI)	‐2.72 [‐4.70, ‐0.74]
3 Blood pressure	20		Mean Difference (IV, Random, 95% CI)	Subtotals only
3.1 Systolic	18	1437	Mean Difference (IV, Random, 95% CI)	‐1.76 [‐5.09, 1.56]
3.2 Diastolic	17	1407	Mean Difference (IV, Random, 95% CI)	‐0.97 [‐2.58, 0.63]
3.3 Arterial	2	186	Mean Difference (IV, Random, 95% CI)	‐9.86 [‐12.06, ‐7.65]
4 Respiration rate	9		Mean Difference (IV, Random, 95% CI)	Totals not selected
5 Sedation requirements (anxiolytics)	3		Mean Difference (IV, Random, 95% CI)	Totals not selected
5.1 Midazolam (aka: Versed, Hypnovel, Dormicum, Dormonid), mg	3		Mean Difference (IV, Random, 95% CI)	0.0 [0.0, 0.0]
6 Peripheral skin temperature	4	298	Std. Mean Difference (IV, Random, 95% CI)	0.15 [‐0.08, 0.37]
7 Oxygen saturation	3	150	Mean Difference (IV, Random, 95% CI)	‐0.71 [‐1.75, 0.32]
8 Mood state	2	170	Mean Difference (IV, Random, 95% CI)	‐1.18 [‐2.17, ‐0.19]
9 Satisfaction	2	174	Std. Mean Difference (IV, Random, 95% CI)	0.46 [0.16, 0.76]
10 Length of stay / Examination time	2	153	Mean Difference (IV, Random, 95% CI)	‐6.00 [‐10.72, ‐1.28]

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Heart rate	2	144	Mean Difference (IV, Random, 95% CI)	4.67 [‐0.76, 10.10]
2 Blood pressure	2		Mean Difference (IV, Random, 95% CI)	Subtotals only
2.1 Systolic	2	144	Mean Difference (IV, Random, 95% CI)	‐1.80 [‐8.59, 5.00]
2.2 Diastolic	2	144	Mean Difference (IV, Random, 95% CI)	0.99 [‐7.60, 9.58]

Methods
Participants
Interventions
Outcomes
Notes	See Table 8
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	‘‘Patients were sequentially selected from the patient rosters of two ophthalmic surgeons. [...] On each day data collection surgeons were randomly assigned to have their patients in the experimental or control group.’’ Method of randomisation not stated.
Allocation concealment (selection bias)	High risk	"Office assistants were unaware of the study prepared patient rosters. On each day data collection surgeons were randomly assigned to have their patients in the experimental or control group. Patients were then approached in the waiting room and asked to participate in the study." Patients approached after allocation.
Blinding (performance bias and detection bias)   Subjective outcomes	High risk	Not extracted for review (validity of measurement scales unclear).
Blinding (performance bias and detection bias)   Objective outcomes	Low risk	Automated measurement of physiological data via Propaq Monitor.
Incomplete outcome data (attrition bias)   All outcomes	Unclear risk	Withdrawals and drop‐outs not described. Physiological outcomes reported for all included patients.
Selective reporting (reporting bias)	Unclear risk	Unknown if selective outcome reporting.
Protection from contamination?	Low risk	Music allocated on an individual basis via headphones.

Methods
Participants	All patients 18 years and older with a diagnosis of cancer undergoing a BMBx in the Johns Hopkins Oncology Center will be screened for enrolment in the study. Based on power calculation, it was planned to enrol 40 patients in each group (total n = 120) to compensate for study withdrawal and missing data.
Interventions	All participants will have pain managed by the physicians responsible for their clinical care as dictated by those physicians. Participants assigned to Nature Sights and Sounds will have Bedscapes fabric panels depicting a scene of a mountain stream placed by the procedure table at a location where it will be visible throughout the procedure. An accompanying audiotape of complementary nature sounds will be played on portable tape players through headphones or speakers. They will be instructed to listen to the tape and look at the nature scene as frequently and for as long as they desire. The standard care group will have pain managed according to current oncology centre protocols but will not be allowed to use the distraction interventions. The Music/Photo group will be played a tape of typical city sounds and will have a poster of a city skyline placed by the procedure table. The city skyline poster will be similar in size to the Bedscapes mural. The skyline image is a daytime photograph without water, trees or other nature elements. The participants will be asked to listen to the music and view the picture during the procedure.
Outcomes	Pain; Profile of Mood States; Brief Symptom Index 18; Salivary cortisol; HR; BP; RR; overall satisfaction with care. Adverse events will be monitored.
Notes	Details obtained from ClinicalTrials.gov Final report not yet obtained.

Trial name or title	The HIP‐HOP Flooring Study: Helping Injury Prevention in Hospitalised Older People
Methods	Pilot cluster randomised controlled trial.
Participants	8 elderly care wards in England (each ward has one bay, the 'study area', included in the study of 4 to 8 beds in size).
Interventions	8.3mm thick floor covering (Omnisports EXCEL) versus standard floor covering
Outcomes	Fall‐related injuries; Falls; Adverse events; Cost‐effectiveness; User views; Slip resistance and shock absorbency of floor.
Starting date	April 2010
Contact information	amy.drahota@port.ac.uk
Notes