Interventions for reducing anxiety in women undergoing colposcopy

Abstract

Background

Prior to the development of cervical cancer abnormal cervical cells can be detected on a cervical smear. The usual practice following an abnormal cervical smear is to perform colposcopy. Colposcopy is the visualisation of the cervix using a binocular microscope. Women experience high levels of anxiety and negative emotional responses at all stages of cervical screening. High levels of anxiety before and during colposcopy can have adverse consequences, including pain and discomfort during the procedure and high loss to follow‐up rates. This review evaluates interventions designed to reduce anxiety levels during colposcopic examination.

Objectives

To compare the efficacy of various interventions aimed at reducing anxiety during colposcopic examination in women.

Search methods

We searched the Cochrane Gynaecological Cancer Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), Issue 3, 2010, MEDLINE and EMBASE up to July 2010. We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.

Selection criteria

Randomised controlled trials (RCTs) of interventions to reduce anxiety during colposcopic examination.

Data collection and analysis

Two review authors independently abstracted data and assessed risk of bias. Mean differences for anxiety levels, knowledge scores, pain, patient satisfaction and psychosexual dysfunction in women who underwent colposcopy were pooled in a random effects meta‐analyses.

Main results

We found six trials that met our inclusion criteria. These trials assessed the effectiveness of different interventions for reducing anxiety in women undergoing colposcopy for the first time.

All comparisons were restricted to single trial analyses or meta analysis of just two trials. There was evidence from a reasonably large trial (n = 220) that was at low risk of bias to suggest that music during colposcopy significantly reduced anxiety levels (MD = ‐4.80, 95% CI: ‐7.86 to ‐1.74) and pain experienced during the procedure (MD = ‐1.71, 95% CI: ‐2.37 to ‐1.05) compared to not listening to music. There was no statistically significant difference between anxiety levels prior to colposcopy in women receiving information leaflets versus no leaflets and information leaflets, video and counselling versus information leaflets and video with no counselling. However, knowledge scores were significantly higher and psychosexual dysfunction scores were significantly lower in women who received leaflets compared to those who did not so there was some sort of benefit to giving patients information leaflets. There is evidence for video colposcopy from a quasi randomised trial which assessed 81 women showing significant anxiety reduction.

Authors' conclusions

Anxiety appears to be reduced by playing music during colposcopy. Although information leaflets did not reduce anxiety levels, they did increase knowledge levels and are therefore useful in obtaining clinical consent to the colposcopic procedure. Leaflets also contributed to improved patient quality of life by reducing psychosexual dysfunction.

Plain language summary

Women can experience high levels of anxiety at all stages of screening for cervical cancer including colposcopy

Women can experience high levels of anxiety at all stages of screening for cervical cancer including colposcopy (visualisation of the cervix by using a binocular microscope). Colposcopy has been shown to be associated with high levels of anxiety, even higher than anxiety levels in women before surgery and similar to the anxiety levels in women following an abnormal screening test for fetal abnormalities. High levels of anxiety before and during colposcopy can have psychological consequences including pain, discomfort and failure to return for follow‐up. This review examined interventions aimed at reducing such anxiety. Anxiety associated with colposcopic examination appears to be reduced by a variety of interventions including playing music during colposcopy, and viewing the procedure on a TV monitor (video colposcopy).

Background

Description of the condition

Cervical cancer is a disease in which malignant cells form in the tissues of the cervix. The development of cancer of the cervix is a multi step process and can take many years. Before it does, cervical cells undergo changes and become abnormal. These abnormalities are not cancerous and are called cervical intra‐epithelial neoplasia (CIN). They are, however, associated with an increased risk of subsequent invasive cancer of the cervix. It is widely accepted that infection with Human Papilloma Virus (HPV) is associated with the development of CIN and cancer. However, not all women with HPV infection, will develop cervical cancer. Regular cervical smears aim to detect abnormal cells in the cervix and once they are detected treatment can be given and cancer can be prevented.

Cervical cancer is the second most common cancer among women up to 65 years of age and is the most frequent cause of death from gynaecological cancers worldwide. A woman's risk of developing cervical cancer by age 65 years ranges from 0.69% in developed countries to 1.38% in developing countries (GLOBOCAN 2008). In Europe, about 60% of women with cervical cancer are alive 5 years after diagnosis (EUROCARE 2003). The incidence of death from cervical cancer has fallen in England and Wales with the death rate now roughly 50% of what it was in 1988 (Peto 2004). This fall was a direct result of the NHS cervical screening programme (Luesley 2004). In the UK, where a high level of compliance with the programme has been achieved, screening may have prevented as many as 6000 deaths in the last decade (Sasieni 2000). More recently it has been estimated that up to 5000 deaths per year are likely to be prevented by screening (Peto 2004).

Description of the intervention

Following an abnormal cervical smear, colposcopy is performed to aid the identification of the transformation zone where cervical neoplasia originates (Coppleson 1968). Colposcopy is the visualization of the cervix using a stereoscopic binocular microscope of low magnification (10x to 40x) (Hacker 2004; Monaghan 1994). Colposcopy facilitates the performance of a diagnostic biopsy or treatment in the form of Large Loop Excision of the Transformation Zone (LLETZ) (Jordan 2004). It is an integral part of the cervical screening programme that aims to prevent cancer in women by detecting precursor lesions which if left untreated could lead to the development of cancer.

Women with an abnormal smear who are referred for colposcopy undergo high levels of stress and anxiety (Marteau 1990). Apart from the fear of having cancer, other concerns and anxieties stem from the uncertainty about what is going to happen and what the colposcopic procedure entails (Kavanagh 1997).

Anxiety is defined as a non‐specific, unpleasant feeling of apprehension, discomfort, and, in some cases, dread and impending doom. It is an uncomfortable emotional state associated with a perceived danger, feelings of powerlessness and prolonged tension in preparation for the expected danger/event. Since high levels of anxiety before colposcopy can have adverse consequences, including pain and discomfort during the procedure and high rate of default (failure to attend the procedure), various interventions have been used to reduce anxiety during colposcopic examination. In patients undergoing surgery studies on the role of information, training in coping strategies and emotional support have been shown to have a positive effect and improved post‐operative recovery (Contrada 1994; Johnson 1993). A variety of interventions have been tried in women undergoing colposcopy to reduce their level of anxiety. They include information booklets, leaflets, video colposcopy and educational counselling.

Why it is important to do this review

It has not been established whether any of the interventions at the time of colposcopy lead to significant reduction in anxiety levels. Therefore we completed this systematic review to determine the effectiveness of interventions used to reduce anxiety during colposcopic examination.

Objectives

1. To compare the efficacy of various interventions aimed at reducing anxiety versus placebo or no interventions in women undergoing colposcopy.
2. To compare the efficacy of one style of anxiety‐reducing intervention versus a second style of anxiety‐reducing intervention in women undergoing colposcopy.

Methods

Criteria for considering studies for this review

Types of studies

Randomised controlled trials (RCTs) looking at interventions to reduce anxiety in women undergoing colposcopy.

Types of participants

Patients of any age undergoing colposcopy for the first time.

Types of interventions

We directly compared any two of the following interventions:

• Written information e.g. information leaflets, booklets

• Educational and counselling (pre‐colposcopy sessions, telephone)

• Cognitive behavioural therapy

• Drugs

• Hypnotherapy

• Acupuncture

• Relaxation therapy

• Music

• Video colposcopy

Additionally, we considered the comparison of any of the above interventions with placebo or no intervention.

Types of outcome measures

The main outcome measures can be both patient and investigator rated.

Primary outcomes

1. Anxiety using a validated scale (e.g. Spielberg State Anxiety Inventory ‐ STAI)

Secondary outcomes

1. Quality of life (QoL) measures using a validated scale (e.g. Short Form‐36 ‐ SF 36)

2. Patient satisfaction using a validated scale

3. Pain during and after colposcopy (e.g. visual analogue scales)

4. Psychosexual scores using a validated scale (e.g. Female Sexual Function Index scores, psychosexual questionnaire ‐ PSex, sexual activity questionnaire ‐ SAQ)

Search methods for identification of studies

Papers in all languages were sought and translations carried out when necessary.

Electronic searches

See: Cochrane Gynaecological Cancer Group methods used in reviews.
The following electronic databases were searched:

• The Cochrane Gynaecological Cancer Collaborative Review Group's Trial Register

• Cochrane Central Register of Controlled Trials (CENTRAL), Issue 3 2010

• MEDLINE (from 1951 to July 2010)

• EMBASE (from 1980 to July 2010)

The Medline, Embase and Central search strategies based on terms related to the review topic are presented in Appendix 1, Appendix 2 and Appendix 3 respectively.

Databases were searched from January 1951 until 2006 in the original review and up to July 2010 in this updated version.

All relevant articles found were identified on PubMed and using the 'related articles' feature, a further search was carried out for newly published articles.

Searching other resources

Unpublished and Grey literature

Metaregister, Physicians Data Query, www.controlled-trials.com/rct, www.clinicaltrials.gov, www.cancer.gov/clinicaltrials, NHMRC Clinical Trials Register and the UKCCCR Register of Cancer Trials were searched for ongoing trials.

Published and unpublished studies were included, if they met the inclusion criteria for the review.

Reference lists and Correspondence

The citation lists of included trials were checked and experts in the field contacted to identify further reports of trials.

Data collection and analysis

Selection of studies

In the original version of the review, titles and abstracts of studies identified from the search were screened by one author to eliminate articles that were obviously not relevant to the search question (KG). The three remaining authors (KG, KD, SS) independently assessed each study according to a checklist of the selection criteria and then independently determined if the study was eligible for inclusion. Disagreements about inclusions were resolved by discussion. Further information was sought from the authors where papers contain insufficient information to make a decision about eligibility.

In the updated version of the review, all titles and abstracts retrieved by electronic searching were downloaded to the reference management database Endnote, duplicates were removed and the remaining references were examined by two review authors (AB, KG) independently. These two authors screened titles and abstracts of references identified from the search and eliminated articles that were obviously not relevant to the search question. When both authors determined that the trial was not eligible for inclusion no further action was taken. When one or both of the authors determined that the article may have been eligible for inclusion, the full text article was obtained. Each author then independently determined if these trials were eligible for inclusion. Disagreements about inclusions were resolved by discussion. Further information were sought from the authors when papers contained insufficient information to make a decision about eligibility. No attempt was made to blind reviewers to article authors or journals.

Data extraction and management

For included studies, data were abstracted as recommended in Chapter 7 of the Cochrane Handbook 2008. This included data on the following:

• Author, year of publication and journal citation (including language)

• Country, location

• Setting

• Inclusion and exclusion criteria

• Study design, methodology

• Study population

  • Total number enrolled

  • Patient characteristics

  • Age

  • How patients were identified

• Total number of intervention groups

• Intervention details

  • Type of intervention: All RCTs of measures to reduce anxiety (e.g. information booklets, leaflets, telephone counselling, music, cognitive behavioural therapy, hypnotherapy, acupuncture, drugs, relaxation therapy)

  • Description of intervention

  • Duration of intervention

  • Type of healthcare professional who provided the intervention

• Control details

  • placebo

  • No intervention

• Risk of bias in study (see below)

• Duration of follow‐up

• Outcomes – anxiety, QoL measures, patient satisfaction, pain during and after colposcopy, psychosexual scores, patient's knowledge about the procedure

• For each outcome: Outcome definition;

• Unit of measurement (if relevant);

• For scales: upper and lower limits, and whether high or low score is good;

• Results: Number of participants allocated to each intervention group;

• For each outcome of interest: Sample size; Missing participants.

Data on outcomes were extracted as below:

• For continuous outcomes (e.g. anxiety measures), we extracted the final value and standard deviation of the outcome of interest and the number of patients assessed at endpoint in each treatment arm at the end of follow‐up, in order to estimate the mean difference (if trials measured outcomes on the same scale) or standardised mean differences (if trials measured outcomes on different scales) between treatment arms and its standard error.

Where possible, all data extracted were those relevant to an intention‐to‐treat analysis, in which participants were analysed in groups to which they were assigned.

Data were abstracted independently by two review authors (AB, KG) onto a data abstraction form specially designed for the review. Differences between review authors were resolved by discussion. AB and KG extracted the data from the included trials in the original review in a way that conformed to the latest version of the Cochrane handbook. This included a thorough assessment of risk of bias (see below).

Assessment of risk of bias in included studies

The risk of bias in included RCTs was assessed using the Cochrane Collaboration's tool and the criteria specified in Chapter 8 of the Cochrane Handbook 2008. This included an assessment of:

• sequence generation

• allocation concealment

• blinding (of participants, healthcare providers and outcome assessors)

• incomplete outcome data: We coded a satisfactory level of loss to follow‐up for each outcome as:

  • Yes, if fewer than 20% of patients were lost to follow‐up and reasons for loss to follow‐up were similar in both treatment arms

  • No, if more than 20% of patients were lost to follow‐up or reasons for loss to follow‐up differed between treatment arms

  • Unclear if loss to follow‐up was not reported

• selective reporting of outcomes

• other possible sources of bias

The risk of bias tool was applied independently by two review authors (AB, KG) and differences were resolved by discussion. Results are presented in the risk of bias table and also in both a risk of bias graph and a risk of bias summary section (see Figure 1; Figure 2). Results of meta‐analyses were interpreted in light of the findings with respect to risk of bias.

1.

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

2.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Measures of treatment effect

We used the following measures of the effect of treatment:

• For continuous outcomes, we used the mean difference between treatment arms.

Dealing with missing data

We did not impute missing outcome data.

Assessment of heterogeneity

Heterogeneity between trials was assessed by visual inspection of forest plots, by estimation of the percentage heterogeneity between trials which cannot be ascribed to sampling variation (Higgins 2003), and by a formal statistical test of the significance of the heterogeneity (Deeks 2001). If there was evidence of substantial heterogeneity, the possible reasons for this were investigated and reported.

Assessment of reporting biases

Funnel plots were not computed in any of the analyses as there were an insufficient number of trials in which to draw valid conclusions.

Data synthesis

If sufficient, clinically similar studies were available, their results were pooled in meta‐analyses.

• For continuous outcomes, the mean differences between the treatment arms at the end of follow‐up were pooled when all trials measured the outcome on the same scale, otherwise standardised mean differences would have been pooled.

 Random effects models with inverse variance weighting were used for all meta‐analyses (DerSomonian 1986).

Sensitivity analysis

We planned to perform sensitivity analyses, excluding trials which did not report adequate:

• Sequence generation

• Concealment of allocation blinding of the outcome assessor.

Results

Description of studies

See Characteristics of included studies; Characteristics of excluded studies

Results of the search

The abstracts of the references identified by the search strategy were read independently by two authors (AB, KG) and articles which obviously did not meet the inclusion criteria were excluded at this stage. Nineteen articles were retrieved in full and translated into English where appropriate and up‐dated versions of relevant studies were identified. The full text screening of these 19 references excluded 13 studies for the reasons described in the table Characteristics of excluded studies. However, six completed RCTs, were identified that met our inclusion criteria and are described in the table Characteristics of included studies.

Searches of the grey literature did not identify any additional relevant studies.

Included studies

All the trials that fulfilled the inclusion criteria were published trials.

Settings

All six trials were of single‐centre design and all were based at hospital outpatient clinics. Four of the included trials were conducted in England (Byrom 2002; Freeman‐Wang 2001; Howells 1999; Marteau 1996), whereas two were conducted in Hong Kong (Chan 2003; Chan 2004) addressing two different populations.

Design

All included trials were randomised and a parallel group design was used, all investigated interventions to reduce anxiety in women having abnormal smear results requiring colposcopic examination.

Participants

A total of 1102 women with cervical abnormalities needing referral to the colposcopy clinic were randomised, of which 886 were assessed. Five trials specified that the women attended colposcopy for the first time, (Byrom 2002; Chan 2003; Chan 2004; Howells 1999; Marteau 1996), whereas the other study implied that the women were attending colposcopy for the first time (Freeman‐Wang 2001). One trial excluded pregnant women and women with severe dyskaryosis (Byrom 2002), two trials excluded pregnant women and women with mental impairment (Chan 2003; Chan 2004) and one study excluded women needing a hysterectomy as well as women with severe dyskaryosis (Howells 1999).

At baseline, the intervention and control groups were similar regarding the prognostic factors in all of the seven trials. Women undergoing colposcopic examination were balanced across the arms of the studies in terms of their demographic data.

Comparisons

Various interventions were used in order to reduce the levels of anxiety experience by women undergoing colposcopic examination and treatment.
(1) Information leaflets versus no information leaflets (Howells 1999; Marteau 1996).
(2) Information leaflets and video + counselling versus information leaflets and video + no counselling (Byrom 2002; Chan 2004).
(3) Listening to music during colposcopy versus usual care (no music), (Chan 2003).

(4) Information leaflets + information video versus Information leaflets only (active comparison), (Freeman‐Wang 2001).

Outcomes

The following outcome measures were reported in the trials:

• Anxiety levels were assessed in all seven trials, where all the trials used the State‐Trait Anxiety Inventory (STAI).

• None of the trials examined the effect of colposcopic examination on the QoL of the women.

• Patient satisfaction was assessed in none of the trials

• Pain experienced during the procedure was assessed in one trial (Chan 2003). The trial of Chan 2003 used a visual analogue scale (VAS).

• Psychosexual morbidity was assessed using psychosexual questionnaire in one study (Howells 1999).

• Women's knowledge about the colposcopic procedure was assessed in three of the trials (Byrom 2002; Chan 2004; Marteau 1996). These trials did not use standard validated knowledge questionnaires.

Anxiety

The State‐Trait Anxiety Inventory (STAI) for adults was used in all of the trials to assess women's anxiety (Spielberger 1983). This consists of 40 self reported items that measure state and trait anxiety score range from 20 to 80, with the lower scores indicating lower anxiety levels. This is a validated reliable and sensitive measure of anxiety, that has been widely used to assess anxiety in adult populations, (Marteau 1992). The fact that all of the studies used the same outcome measure for anxiety makes the meta‐analysis simpler.

Quality of Life

Despite there being a large number of outcome measures to assess QoL that are sensitive and reliable in adults e.g. SF‐36 (Brazier 1992), none were used in any of the included trials.

Knowledge

Three of the trials (Byrom 2002; Chan 2004; Marteau 1996) assessed whether the patient's knowledge of the procedure had been improved by their interventions. Each study generated their own questionnaire, the details of which were mostly unclear, so comparison between these results is difficult as different aspects of knowledge may well have been assessed by each questionnaire. For example, one of the excluded trials (Walsh 2004) assessed knowledge by asking the participants "What is your understanding of abnormal smear result?" There were three possible responses, "cancer", "pre‐cancer", "don't know". Obviously this does not assess the patient's knowledge of the colposcopic procedure just the reason for it.

Pain

The trial of Chan 2003 assessed the patient's levels of pain experienced during the colposcopic procedure. This trial used a patient completed visual analogue scale (VAS). The results of a VAS can be significantly influenced by the phrases (the anchor statements) that are used at each end of the line, e.g. no pain versus worst pain, these were the anchor phrases used by Chan 2003. From a practical perspective, the VAS is an easy to use patient centred measure of pain intensity. It is internally consistent with respect to the patient themselves, but a VAS may not be a valid tool to use within large scale clinical trials. In addition, the VAS is subject to measurement errors by the investigator, it is associated with additional administrative burdens due to the need to explain the VAS to the patient (i.e. to ensure that he/she understands that the VAS is meant to represent a continuum of pain), the need to measure the patient's rating and the need for quality assurance resources to verify that the measurement is accurate (de Jong 2005).

Patient satisfaction

None of the trials measured patient satisfaction.

Psychosexual scores

Only Howells 1999 assessed the psychosexual outcomes for the participants in their study. They used Campion's questionnaire (Campion 1988), whilst not validated this as an outcome measure this questionnaire has been used in other similar patient populations and proven to be sensitive.

Adverse events

None of the trials reported any adverse events associated with their intervention.

Duration of follow up

Due to the nature of the intervention i.e. reduction of anxiety for a single clinical event (colposcopy) long term effects were not required of the interventions. However a reduction in anxiety during the colposcopic procedure may have increased the chances of the patients re‐attending for further clinical follow‐up appointments. The duration of clinical follow up ranged between four weeks and one year in the trials.

Sample size described in each group

Sample size and power calculations were performed in four trials (Byrom 2002; Chan 2003; Chan 2004; Howells 1999). All of the trials described the number of women in the intervention and control group. Patient numbers were small generally ranging from 13 to 50 in each arm for most of the studies, but three studies had significantly larger groups of participants. There were 112 in the intervention arm and 108 in the control arm in the two trials by Chan et al. (Chan 2003; Chan 2004). The trials were conducted one year apart in the same institution, and we have checked with the authors that indeed the two trials were on two completely different group of Chinese women undergoing colposcopic examination. There were 107 in the intervention arm and 103 in the control arm in the trial of Howells 1999.

ITT analysis

ITT analysis of the results was performed in four studies (Byrom 2002; Chan 2003; Chan 2004; Howells 1999). This could have introduced bias into the remaining study's analyses. All of the studies included did compare their data statistically between the groups for at least the primary outcome measure (anxiety).

Ethics

Investigators in a trial should adhere to The International Conference on Harmonisation (ICH) guidelines on Good Clinical Practice (GCP) and to the ethical principles that have their origin in the Declaration of Helsinki. Detailed information about the proposed trial either verbal or written are required, and the requirements have been getting tighter over the years. Currently in the UK a written information leaflet is provided to research participants which details the purpose of the trial, the intervention proposed, trial procedures etc. After patients have read and understood the information provided they must then provide written consent to participate in the research project. However it is recognised that different ethical standards and procedures existed in previous times and exist currently in different countries.

Of the six trials reviewed, the principles of research consent were followed in all but one trial (Howells 1999). Most of the trials have given either written information to their participant or stated that they had provided verbal information. In the trial of Howells 1999, no information either verbal or written was given to the control groups.

Excluded studies

Nineteen studies which investigated anxiety in women having abnormal cervical smears needing colposcopic assessment were initially selected, but 12 were excluded as they did not meet the inclusion criteria. Six studies were excluded because they did not investigate an intervention to reduce anxiety (Clifton 1998; Cruickshank 2005; Johnson 1989; Kitchener 2004; Peters 1999; Philips 2002), four studies were quasi‐randomised trials (Greimel 1997; Sarkar 1993; Tomaino‐Brunner 1998; Walsh 2004) and a further study was excluded because it was not randomised (French 2004). The trial of Danhauer 2007 assessed music or guided imagery versus usual care for women undergoing colposcopy, but 32% of 170 women in the trial had received previous colposcopy. Rickert 1994 reported on two trials in one paper, but patients included adolescent females between the age of 13 to 20 years.

For further details of all the excluded studies see the Characteristics of excluded studies.

Risk of bias in included studies

Only two trials (Chan 2003; Chan 2004) were at low risk of bias as they satisfied four of the criteria that we used to assess risk of bias. Two trials (Byrom 2002; Howells 1999) were at moderate risk of bias as they satisfied three of the criteria and the trials of Freeman‐Wang 2001 and Marteau 1996 were at high risk of bias as they only satisfied one criterion (see Figure 1, Figure 2).

Of the six trials that were identified, four trials (Byrom 2002; Chan 2003; Chan 2004; Howells 1999) were adequately randomised using computer generated random numbers and which were concealed until allocation by means of opaque sealed envelops. This resulted in adequate concealment of the allocation. The method of randomisation and allocation concealment was not reported in the other two trials (Freeman‐Wang 2001; Marteau 1996).

None of the trials blinded the patients. These are trials assessing anxiety reduction interventions in women having colposcopic examination. The women would have been aware whether they had received the intervention or not, therefore they could not have been blinded. The relevant outcomes in this review are subjective and thus best rated by the patient's themselves. It is acknowledged that this could have introduced bias, but it is unavoidable because of the nature of the interventions and the outcomes. It may have been possible to blind care providers or outcome assessors but this was not reported in any of the trials examined. This could have introduced bias.

It seemed fairly certain that all of the included trials reported all the outcomes that they assessed, but it was unclear whether any other bias may have been present. At least 80% of women who were enrolled were assessed at endpoint in two trials (Chan 2003; Chan 2004), but there were substantial rates of attrition in the four remaining trials (Byrom 2002; Freeman‐Wang 2001; Howells 1999; Marteau 1996).

Effects of interventions

A total of 886 women undergoing colposcopic examination were assessed in these trials. The included trials investigated different interventions which were used primarily to reduce the levels of anxiety in women undergoing colposcopic examination and treatments. The results were as follows:

(1) Anxiety levels

(a) Information leaflets versus no information leaflets

Data were available from two trials (Howells 1999; Marteau 1996) assessing 373 participants who had been randomised to either information leaflets prior to their colposcopic examination or to no information leaflets. The smallest trial of Marteau 1996 (n=15 in the treatment group versus n=13 in the control group) showed a significant reduction in the anxiety levels in women receiving specifically designed information leaflets (MD = ‐8.70, 95% CI: ‐14.61 to ‐2.79). The larger Howells 1999 trial showed no significant reduction in anxiety (MD = 1.54, 95% CI: ‐1.71 to 4.79). Meta‐analysis of these two trials found no significant difference in anxiety levels between women receiving information leaflets and those not receiving leaflets (MD = ‐3.27, 95% CI: ‐13.29 to 6.75). The percentage of the variability in effect estimates that is due to heterogeneity rather than sampling error (chance) may represent considerable heterogeneity (I² = 89%). The heterogeneity found was likely to reflect differences in the size and character of the patient populations examined, possible differences in the contents of the information leaflets, as well as differences in the methodological quality of the different trials.

(b) Information leaflets and video plus counselling versus information leaflets and video plus no counselling

Meta‐analysis of two trials (Byrom 2002; Chan 2004), assessing 345 participants, found no statistically significant difference in anxiety levels between women who received information leaflets, video sessions and counselling and those who received just information leaflets and the video session (MD = ‐1.29, 95% CI: ‐3.80 to 1.22). The percentage of the variability in effect estimates that is due to heterogeneity rather than by chance is not important (I² = 0%).

(c) Listening to music during colposcopy versus no music

There was one trial that assessed the effect of music on anxiety levels; the trial (Chan 2003) compared 112 women who listened to music during the procedure and 108 who did not. This single trial which was at low risk of bias found that listening to music during colposcopic examination was associated with a significant reduction in anxiety levels compared to not listening to music (MD= ‐4.80 (95% CI: ‐7.86 to ‐1.74).

(d) Information leaflets plus information video versus information leaflets only

The Freeman‐Wang 2001 trial compared 48 women receiving an information leaflet in combination with information video and 45 women receiving information leaflets only. They assessed if the information video in combination with the information leaflet would lead to reduction in anxiety levels in comparison to information leaflets only. The trial demonstrated that the combination of interventions resulted in a highly significant reduction in anxiety level (MD= ‐11.50, 95% CI: ‐16.52 to ‐6.48).

(2) QOL

None of the trials reported on the effect of anxiety reduction interventions prior to a colposcopic examination on the QoL of the women.

(3) Knowledge scores

Knowledge scores were presented as the percentage of correct answers to a variety of questions used in questionnaires by the different trials presented here.

(a) Information leaflets versus no information leaflets

Marteau 1996 tried to determine if there was an increase in women's knowledge about colposcopy after reading the leaflets. They determined that there was a significantly lower knowledge score in the control group compared to the intervention group. The knowledge score in the intervention group was 8.4, and 5.8 in the control group, (MD= 2.60, 95% CI: 1.33 to 3.78).

(b) Information leaflets and video plus counselling versus information leaflets and video plus no counselling

Two trials (Byrom 2002; Chan 2004) using information leaflets and video plus counselling versus information leaflets and video with no counselling assessed women's knowledge about colposcopy. Meta‐analysis of these trials, which assessed 345 participants, found no statistically significant difference in knowledge scores between women in the two groups (MD = 0.76, 95% CI: ‐0.33 to 1.85). The percentage of the variability in effect estimates that is due to heterogeneity rather than chance may represent considerable heterogeneity (I² = 77%). The knowledge scores were lower in the control group in both trials.

Knowledge scores were not assessed in any of the other studies examining other interventions.

(4) Pain during colposcopic examination

(a) Listening to music during colposcopy versus no music

Pain reduction was assessed by Chan 2003 using a visual analogue scale (VAS). There was a significant reduction in the pain experienced during colposcopic examination in the intervention group where women listened to music compared to the control group (‐1.71 95% CI: ‐2.37 to ‐1.05).

Pain during the colposcopic procedure was not assessed in any of the other studies examining other interventions.

(5) Patient satisfaction

None of the trials reported patient satisfaction as an outcome.

(6) Psychosexual scores

Information leaflets versus no information leaflets

Only one trial addressed the psychosexual dysfunction using Campion's questionnaire (Campion 1988), experienced by women undergoing colposcopic examination after an abnormal cervical smear result (Howells 1999). They addressed sexual spontaneous interest, comparing the rates of spontaneous interest in the intervention and control group. The results have shown that women receiving leaflets had significantly less psychosexual dysfunction (more spontaneous interest) when compared with women in the control group. The psychosexual score was 2.29 for the intervention group and 3.48 for the control group (MD= ‐0.56, 95% CI: ‐0.60 to ‐0.52).

Discussion

Summary of main results

Colposcopy has been associated with high levels of anxiety, even higher than anxiety levels in women before surgery (Johnson 1980; Marteau 1990), and similar to the anxiety levels in women following an abnormal serum screening for fetal abnormalities (Marteau 1988). High levels of anxiety before and during colposcopy can have adverse psychological consequences, including impairment of mood, daily activities, sleep and sexual interest in women with abnormal smears compared with controls (Lerman 1991). The high levels of anxiety could result in an increase in pain and discomfort experienced during the procedure and also high rate of loss to follow‐up (Lerman 1991). The high anxiety levels and psychological stress may also result in a decreased ability to recall and act on advice, which can make women less likely to comply with the information they are given (Sorg 1992). This review has evaluated the possible effectiveness of different interventions used to reduce the levels of anxiety experienced by women undergoing colposcopic examination. We found evidence that playing music during colposcopy reduces anxiety levels and pain experienced during the procedure compared to not listening to music. We also found that watching an information video in addition to receiving an information leaflet reduces anxiety levels compared to receiving leaflets only. There was no statistically significant difference between anxiety levels prior to colposcopy in women receiving information leaflets versus no leaflets and information leaflets, video and counselling versus information leaflets and video with no counselling. However, knowledge scores were significantly higher and psychosexual dysfunction scores were significantly lower in women who received leaflets compared to those who did not so there was some sort of benefit to giving patients information leaflets.

Overall completeness and applicability of evidence

• There was insufficient evidence to support or refute the use of;

  • information leaflets compared to no information leaflets to increase the level of knowledge

  • counselling compared to no counselling to reduce anxiety as this was only reported in a quasi‐RCT which was excluded from the review.

  • video colposcopy compared to no video colposcopy to reduce anxiety as it was only reported in a small trial that included adolescent females that was excluded from the review.

  • information using graphs and verbal information plus information video versus information only when sought, to reduce anxiety, improve knowledge and patient satisfaction

  • information leaflets plus information video versus information leaflets only to reduce anxiety

• Large well designed RCTs are needed to demonstrate the efficacy and effectiveness of anxiety reduction techniques in women undergoing colposcopy.

The validity of a systematic review is influenced by the validity of its component studies. This review is limited in its ability to reach meaningful conclusion on the effectiveness of some interventions because some trials suffered from small numbers, poor methodological quality and in most cases moderate or high risk of bias.

This review has determined that there is evidence to suggest that an effective method of reducing anxiety and pain during colposcopy is to play music. This is a very simple and cheap intervention, the clinic could ask patients to bring along their own music, and if needed their own music media players (CD or MP3 player).

Information sheets have a number of aims, anxiety reduction being only one of them. Patients need to be fully informed before they give consent to clinical procedures so that they understand the benefits and any potential risks associated with them. Providing written material allows the patients to digest the information at their own pace and therefore be more likely to comprehend and retain the information required. Overall this review suggests that written information sheets do not reduce anxiety levels, although they may reduce psychosexual dysfunction and improve knowledge scores.

A number of the trials in this review examined whether providing information in a number of formats e.g. with leaflets and video, or with additional support e.g. with counselling is most effective. However all of these trials were relatively small and methodologically flawed and so no definitive answer can be derived from the evidence presented. Logically it can be suggested that information provided in more than one format e.g. with video and information leaflets, may be more easily understood. However the addition of a counsellor has the potential to be very costly and at present the evidence does not support the use of counsellors, although more evidence is probably needed.

Colposcopy is associated with high levels of anxiety, therefore anxiety reduction is an important aspect of providing good care for women having colposcopic examination. High levels of anxiety are associated with psychological morbidity and can lead to higher rates of loss to follow up. This review has shown in one adequately powered trial (Chan 2003) that the simple intervention of playing music during the colposcopic procedure reduces anxiety and pain.

Quality of the evidence

Overall the methodological quality of the trials and the standard of the reporting was poor. All six trials were published after the CONSORT guidelines were published (Begg 1996), when trial methodology and reporting was more formalised, so this finding is disappointing.

Of the six trials included in this review only four trials used adequate methods of randomisation and concealment of allocation (Byrom 2002; Chan 2003; Chan 2004; Howells 1999), whereas the remaining trials did not report their methods (Freeman‐Wang 2001; Marteau 1996). We excluded quasi‐randomised trials as they had the potential to introduce significant selection bias into the study (Chalmers 1983; Moher 1998; Schulz 1995).

Patient numbers ranged from very small (n = 13) in each arm to adequate (n = 112), although the numbers of participants in most trials was small. There were 220 participants in both Chan trials (Chan 2003; Chan 2004) and 210 in the trial of Howells 1999 which was deemed adequate, but generally the number of patients in each of the trials was not satisfactory, especially as many of the comparisons were based on single trial analyses.

All of the trials measured anxiety using the STAI. Despite the association between pain and anxiety only one trial (Chan 2003) measured pain. None of the included trials assessed QoL, and only one trial (Howells 1999) measured psychosexual scores. Three trials measured knowledge and no trial measured patient satisfaction, except for some of the excluded quasi‐RCTs.

Six RCTs assessing 886 participants were found that compared the efficacy of various interventions aimed at reducing anxiety versus no interventions or that compared the efficacy of one style of anxiety‐reducing intervention versus a second style of anxiety‐reducing intervention in women undergoing colposcopy. These trials varied significantly in the quality of their methodology and their risk of bias.

The methods used to reduce anxiety prior to and during colposcopy in these trials varied considerably. There does not appear to be a consensus in the field as to what method to reduce anxiety is most appropriate to treat women undergoing colposcopy.

The use of information leaflets compared to no information leaflets appears to not reduce anxiety levels in women undergoing colposcopy. However it does appear that this intervention reduces psychosexual dysfunction and increases women's knowledge scores.

Listening to music during colposcopy compared to no music showed a significant reduction in the levels of anxiety and pain experienced.

The addition of a counselling component to an intervention that already included information leaflets and a video demonstrated no significant effect on anxiety levels nor improvement in the knowledge scores.

Potential biases in the review process

A comprehensive search was performed, including a thorough search of the grey literature and all studies were sifted and data extracted by three review authors independently. In the update of the review we restricted the included studies to RCTs as they provide the strongest level of evidence available. Hence we have attempted to reduce bias in the review process.

The greatest threat to the validity of the review is likely to be the possibility of publication bias i.e. studies that did not find the treatment to have been effective may not have been published. We were unable to assess this possibility as we found only three included trials.

Agreements and disagreements with other studies or reviews

The Quasi RCT of Sarkar 1993 adopted a parallel group design. Women with an even hospital number were assigned to pre‐colposcopy counselling (intervention group) and women with an odd hospital number assigned to no counselling (control group). In this trial, 59 women aged between 16 and 49 years with abnormal smears attending colposcopy for the first time were included in a hospital outpatient refuelling questionnaire setting. STAI questionnaire and standardised anxiety and depression scales were measured before the intervention and after colposcopy. This study did not show a statistically significant reduction in anxiety levels in those that received counselling. This study had very small numbers in the intervention (n = 29) and control groups (n = 30). Counselling was not examined in any of the included trials in the review.

The authors of one trial (Danhauer 2007) hypothesised that music or guided imagery versus usual care would result in less anxiety and perceived pain for colposcopy patients. 170 colposcopy patients were randomised to music, guided imagery, or usual care after completing a baseline questionnaire. All patients completed a post‐procedure questionnaire. Study participants had a mean age of 28.4 years (SD = 9.6; range 18 to 60) and formed a racially diverse group. Education and income levels were low. No between‐group differences were found for post‐procedure anxiety or pain rating. The trial was at moderate risk of bias. Study participants were randomised using simple randomisation with an equal probability to 1 of the 3 study groups; this was operationalised by having each participant select a random assignment slip. A research assistant was responsible for assembling study forms/materials and data entry, but it was unclear as to whether they were blinded. Mind‐body interventions had no statistically significant impact on reported anxiety, perceived pain, or satisfaction with care, even for those who anticipated the most pain or started with high anxiety.

The Quasi RCT of Walsh 2004 used parallel group design. Every second patient was assigned to intervention group. 81 women aged between 20 and 40 years of age, with abnormal smears attending colposcopy for the first time were included in the trial. The 81 women were divided into two sub‐groups, 43 in a laser colposcopy group and 38 in a colposcopy review (normal re‐check) group. The intervention was a video colposcopy where the participant was able to observe a monitor presenting real time images of the cervix during procedure. Anxiety was assessed using STAI, knowledge assessed using semi‐structured interview and pain was assessed by asking the women how severe was the pain before and after interventions. Anxiety levels were checked after video colposcopy in both groups. In the colposcopy review group there was 20 women in the intervention group and 18 in the control group. The trial assessed the effect of viewing the colposcopy through video (video colposcopy) on the levels of anxiety in women. It showed that video colposcopy was associated with reduction in anxiety levels (MD = ‐10.08,95% CI ‐15.40 to ‐4.76; P < 0.001). In the laser group there were 22 participants in the intervention group and 21 in the control group. The mean anxiety level was significantly reduced in the video group compared to the group that did not see the video (MD = ‐8.43, 95% CI: ‐12.24 to ‐4.62 P < 0.01). Walsh 2004 also assessed pain experienced by women undergoing colposcopic examination as a secondary outcome. The mean pain score in the video group was significantly lower than in the group that did not see the video (MD = ‐1.02,95% CI ‐1.47 to ‐0.57, P<0.01). Pain during the colposcopic procedure was not assessed in any of the included studies examining other interventions. The trial also assessed patient satisfaction of their experience of treatment in the colposcopy clinic. They did not show any significant difference between the two groups. This study used a poor method of randomisation and concealment of allocation, therefore overall there was insufficient evidence to support or refute the use of video colposcopy to reduce anxiety in women undergoing colposcopy.

The quasi‐RCT of Tomaino‐Brunner 1998used a parallel group design. Randomisation was based on the week of scheduled appointment so concealment of allocation was not possible. The trial included 103 women attending colposcopy for the first time. Information leaflets were given to women in the intervention group one week before colposcopy. The control group did not receive an information leaflet. patients completed STAI and knowledge questionnaires before and after the intervention. Drop‐out rates were similar in the intervention and control groups. We identified three studies that examined this type of intervention. The smallest study which was included in this review (n = 28) (Marteau 1996) showed significant reductions in anxiety levels, they also showed that using a simple information booklet is associated with reduced anxiety. This may suggest that the content of the information leaflets/ booklet is important in anxiety reduction. In addition two larger studies (Howells 1999;Tomaino‐Brunner 1998) did not show statistically significant reductions in anxiety levels. Given the methodological flaws of these studies and the small number of patients examined, we are unable to support or refute that information leaflets reduce anxiety levels.

Greimel 1997 was a quasi‐RCT trial which randomised according to date of birth of the patients. 147 women with cervical abnormalities attending colposcopy clinic for the first time were included. Women with previous diagnosis of smear abnormalities and women who have had hysterectomy were excluded. The trial included three intervention groups which compared information given verbally without teaching aids, information given verbally and in graph form and verbal information with information video of colposcopy. There was also a control group where women were given information only on request. Anxiety was measured using STAI, patient satisfaction was assessed using the Likert scale and knowledge was assessed with semi‐structured interviews. Outcomes were measured just prior to the intervention and immediately after the colposcopy. The trial compared 35 women having verbal information, information using visual aids and video information versus 35 women in the control group which were given information only when they sought it. The mean reduction in the level of anxiety was not significant. . The trial assessed the knowledge in the women in the intervention group (counselling) compared to the control group. There was significantly lower knowledge scores in the control group compared to the intervention group. The knowledge score in the intervention group was 10.6 and 8.50 in the control group (MD = 2.1, 95% CI: 0.92 to 3.28, P < 0.01). Knowledge scores were not assessed in any of the other studies examining other interventions. Greimel 1997 also assessed patient satisfaction. In their study satisfaction scores were significantly improved in the intervention group compared to the control group (MD = 14.10, 95% CI 10.50 to 17.70, P < 0.01).

Authors' conclusions

Implications for practice.

• Playing music during the colposcopic procedure is a simple intervention that could help to reduce the woman's anxiety and pain.

• Information leaflets are important for informed consent procedures and may reduce psychosexual dysfunction.

• Counselling may not be too useful as when given in addition to information provided in written and video formats it does not reduce anxiety nor improve knowledge. More trials are needed to adequately assess the impact of counselling.

Implications for research.

• The methods used to reduce anxiety prior to and during colposcopy used in these trials varied considerably. There does not appear to be a consensus in the field as to what method to reduce anxiety is most appropriate to treat women undergoing colposcopy. It would be useful to conduct a survey so as to identify current practice and also obtain clinicians views on best practice. This would then inform future research to evaluate the efficacy of such interventions.

• Although music was shown to be effective in reducing anxiety and pain, it would be useful to repeat these findings in a second RCT that included other outcomes such as QoL, health economics evaluation, attendance at follow‐up clinics, patient satisfaction and psychosexual scores. RCTs comparing music alone versus music in conjunction with information leaflets and videos are recommended.

• Well designed RCTs are needed to determine whether counselling is beneficial in reducing anxiety prior to colposcopy.

• Better evaluation of how women are given the information they require before they undergo colposcopic procedures, what information is required, what information is retained, and the impact of this information on outcomes such as anxiety, pain, QoL and psychosexual scores.

• This review has highlighted many methodological shortcomings which have a bearing on the conduct of future trials of interventions to reduce anxiety in women undergoing colposcopy.

What's new

Date	Event	Description
5 January 2022	Amended	No longer for update as any future update will require the development of a new protocol reflecting current Cochrane methodological criteria.

History

Protocol first published: Issue 2, 2006
Review first published: Issue 3, 2007

Date	Event	Description
11 February 2015	Amended	Contact details updated.
27 March 2014	Amended	Contact details updated.
3 November 2011	New citation required but conclusions have not changed	New author added.
3 November 2011	New search has been performed	New search conducted and new author added.
20 May 2007	New citation required and conclusions have changed	Substantive amendment

Appendices

Appendix 1. Medline search strategy

Updated Medline search strategy 2006 to July week 4 2010

1. Colposcopy/

2. colposcop*.mp.

3. precolposcop*.mp.

4. pre‐colposcop*.mp.

5. 1 or 2 or 3 or 4

6. Anxiety/

7. (anxiet* or anxious*).mp.

8. nervous*.mp.

9. concern*.mp.

10. worr*.mp.

11. fear*.mp.

12. apprehens*.mp.

13. 6 or 7 or 8 or 9 or 10 or 11 or 12

14. 5 and 13

15. limit 14 to yr="2006 ‐ 2010"

key:

mp=title, original title, abstract, name of substance word, subject heading word, unique identifier

Appendix 2. Embase search strategy

Updated Embase search strategy 2006 to 2010 week 31

1. colposcopy/

2. colposcop*.mp.

3. precolposcop*.mp.

4. pre‐colposcop*.mp.

5. 1 or 2 or 3 or 4

6. ANXIETY/

7. (anxiet* or anxious*).mp.

8. nervous*.mp.

9. concern*.mp.

10. worr*.mp.

11. fear*.mp.

12. apprehens*.mp.

13. 6 or 7 or 8 or 9 or 10 or 11 or 12

14. 5 and 13

15. limit 14 to yr="2006 ‐ 2010"

key:

mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer

Appendix 3. Central search strategy

Updated CENTRAL search strategy, Issue 3 2010  (2006‐2010)

1. MeSH descriptor Colposcopy explode all trees

2. colposcop*

3. precolposcop*

4. pre‐colposcop*

5. (#1 OR #2 OR #3 OR #4)

6. MeSH descriptor Anxiety explode all trees

7. anxiet* or anxious*

8. nervous*

9. concern*

10. worr*

11. fear*

12. apprehens*

13. (#6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12)

14. (#5 AND #13)

15. (#14), from 2006 to 2010

Data and analyses

Comparison 1. Information leaflets versus no information leaflets.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Anxiety levels (STAI)	2	228	Mean Difference (IV, Random, 95% CI)	‐3.28 [‐13.29, 6.74]
1.2 Knowledge scores	1		Mean Difference (IV, Random, 95% CI)	Subtotals only
1.3 Psychosexual dysfunction	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1. Analysis.

Comparison 1: Information leaflets versus no information leaflets, Outcome 1: Anxiety levels (STAI)

1.2. Analysis.

Comparison 1: Information leaflets versus no information leaflets, Outcome 2: Knowledge scores

1.3. Analysis.

Comparison 1: Information leaflets versus no information leaflets, Outcome 3: Psychosexual dysfunction

Comparison 2. Information leaflets and video + counselling vs. information leaflets and video + no counselling.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Anxiety levels (STAI)	2	345	Mean Difference (IV, Random, 95% CI)	‐1.29 [‐3.80, 1.22]
2.2 Knowledge scores	2	345	Mean Difference (IV, Random, 95% CI)	0.76 [‐0.33, 1.85]

2.1. Analysis.

Comparison 2: Information leaflets and video + counselling vs. information leaflets and video + no counselling, Outcome 1: Anxiety levels (STAI)

2.2. Analysis.

Comparison 2: Information leaflets and video + counselling vs. information leaflets and video + no counselling, Outcome 2: Knowledge scores

Comparison 3. Music during colposcopy versus no music.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Anxiety levels (STAI)	1		Mean Difference (IV, Random, 95% CI)	Subtotals only
3.2 Pain experienced during procedure (VAS)	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1. Analysis.

Comparison 3: Music during colposcopy versus no music, Outcome 1: Anxiety levels (STAI)

3.2. Analysis.

Comparison 3: Music during colposcopy versus no music, Outcome 2: Pain experienced during procedure (VAS)

Comparison 4. Information leaflets + information video vs. Information leaflets only.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Anxiety levels	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

4.1. Analysis.

Comparison 4: Information leaflets + information video vs. Information leaflets only, Outcome 1: Anxiety levels

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Byrom 2002.

Study characteristics
Methods	Randomised, parallel group design.
Participants	196 women (aged between 20 to 60 yrs.) referred for colposcopy for the first time with moderate dyskaryosis or less were randomised. Women with severe dyskaryosis and pregnant women were excluded. 147 women agreed to take part in the study. Analysis was done on intention to treat. All women received a locally produced information leaflet. At the clinic before colposcopic examination, women were counselled by a colposcopy nurse.
Interventions	All women received locally produced information leaflet and counselling by colposcopy nurse. Intervention group received an additional counselling session that lasted 60‐90 minutes. These sessions were held in the evening and were led by an experienced colposcopic nurse who had training in counselling. The sessions were group sessions they lasted for 60‐90 minutes during which information video about colposcopy was shown.
Outcomes	Anxiety was measured using STAI, General health questionnaire, Abnormal smears questionnaire, Cervical screening questionnaire Measures were taken 4 weeks before appointment, immediately prior to colposcopy and 6 weeks post colposcopy.
Notes	Follow up: six weeks.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Women eligible for the study were initially randomised into two groups by the clinic secretary using a computer‐generated random numbers series".
Allocation concealment (selection bias)	Low risk	"Women ... were initially randomised ... using a computer‐generated random numbers series contained within closed opaque envelopes".
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	% analysed: 100/196 (51%) were assessed at stage one, 125/196 (64%) at stage two and just 59/196 (30%) were assessed at stage 3 of the intervention.
Selective reporting (reporting bias)	Low risk	There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive.
Other bias	Unclear risk	Insufficient information to assess whether an additional risk of bias exists.

Chan 2003.

Study characteristics
Methods	Randomised, parallel group design. Analysis of the results was not done on an intention‐to‐treat basis.
Participants	220 women with smear abnormality attending colposcopy clinic for the first time were randomised. Women with mental impairment and pregnant women were excluded.
Interventions	Women's favourite music played through speakers during colposcopic examination. For the control group no music was played.
Outcomes	Anxiety was measured using STAI, and knowledge was measured using questionnaire immediately post colposcopy. Pain was assessed using visual analogue scale (VAS). Outcomes were measure just prior to the colposcopy and immediately afterwards.
Notes	Drop out rates were similar in the intervention and control groups.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Subjects were randomly assigned ... using a computer‐generated random number series".
Allocation concealment (selection bias)	Low risk	"Computer‐generated random number series contained within closed opaque envelopes".
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	% analysed: 220/220 (100%)
Selective reporting (reporting bias)	Low risk	There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive.
Other bias	Unclear risk	Insufficient information to assess whether an additional risk of bias exists.

Chan 2004.

Study characteristics
Methods	Randomised, parallel group design. Analysis of the results was not done on an intention‐to‐treat basis.
Participants	220 women with mild to moderate dyskaryosis on smear attending colposcopy clinic for the first time were randomised. Women with mental impairment were excluded. Follow‐up for 1 year.
Interventions	Locally produced information leaflet followed by watching information video given to both groups. Intervention group received counselling further explanation and discussion by experienced colposcopy nurse.
Outcomes	Anxiety was measured using STAI, and knowledge of the procedure using a questionnaire. Outcomes were measure just prior to the intervention and immediately after the colposcopy.
Notes	One year follow up clinical data. Drop out rates were similar in the intervention and control groups.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Eligible subjects were randomly assigned ... using a computer‐generated random number series".
Allocation concealment (selection bias)	Low risk	"Eligible subjects were randomly assigned ... using a computer‐generated random number series contained within closed opaque envelopes".
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	Low risk	% analysed: 220/220 (100%)
Selective reporting (reporting bias)	Low risk	There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive.
Other bias	Unclear risk	Insufficient information to assess whether an additional risk of bias exists.

Freeman‐Wang 2001.

Study characteristics
Methods	RCT, Parallel design. Single centre study. Analysis of the results was not on an intention‐to‐treat basis.
Participants	132 women with moderate to severe dyskaryosis attending colposcopy clinic for the first time were randomised.
Interventions	All women received information leaflet. Intervention group received information leaflet and an information video that lasted for 7 minutes.
Outcomes	Anxiety was measured using STAI at first attendance and after intervention.
Notes	Loss to follow‐up, 16 in the intervention group and 23 in the control group. Information video costs were 1.50 sterling pound per woman.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"All new referrals ... were randomly allocated to receive either the explanatory video or the standard information". The method of sequence generation was not reported.
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	% analysed: 93/132 (70%)
Selective reporting (reporting bias)	Low risk	There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive.
Other bias	Unclear risk	Insufficient information to assess whether an additional risk of bias exists.

Howells 1999.

Study characteristics
Methods	Randomised, parallel group design. Results not analysed on an intention‐to‐treat basis.
Participants	210 women, with no previous colposcopy and cytological abnormality no greater than moderate dyskaryosis were randomised. 6 months follow‐up.
Interventions	Those agreeing to take part were interviewed before the routine pre‐colposcopy counselling by two authors (T.I, P.D) who were unaware whether they received information leaflets. Intervention group: received information leaflet Control group: received no leaflets.
Outcomes	Each patient completed STAI and modified psychosexual questionnaire. Anxiety was measured using STAI and psychosexual questionnaire. Outcomes were measured just prior to the intervention and just after the colposcopy procedure.
Notes	Follow‐up for 6 months.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Initially 210 consecutive patients were assigned to one of two groups by the clinic manager using a computer derived random number series".
Allocation concealment (selection bias)	Low risk	"Patients were assigned ... using a computer derived random number series contained within closed opaque envelopes".
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	% analysed: 200/210 (95%) were assessed at first visit and 143/210 (68%) were assessed at second visit.
Selective reporting (reporting bias)	Low risk	There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive.
Other bias	Unclear risk	Insufficient information to assess whether an additional risk of bias exists.

Marteau 1996.

Study characteristics
Methods	Randomised, parallel group design. Results not analysed on an intention‐to‐treat basis.
Participants	124 women with mild to severe cervical abnormalities attending colposcopy clinic for the first time were randomised.
Interventions	Control group: Group 1 (N=13): standard appointment letter Intervention groups: Group 2 (N= 21): "Your visit to the Royal Free Hospital" booklet, with information about procedure and instructions on dealing with colposcopy with behavioural, physical strategies and details about likely outcomes. Group 3 (N=15): WHRRIC booklet "An abnormal smear what does it mean?", details about aetiology of abnormal smear and likely outcomes. Group 4 (N=15): RFH booklet and the WHRRIC booklet
Outcomes	Anxiety was measured using STAI, knowledge assessed using questionnaire. Outcomes were measured just prior to the intervention and after the colposcopy.
Notes	Drop out rates were similar in the intervention and control groups.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"A total of 124 women ... were randomly allocated to one of four groups". The method of sequence generation was not reported.
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	% analysed: 28/62 (45%)
Selective reporting (reporting bias)	Low risk	There was no reason to suspect that outcomes had been selectively reported and they appear to be comprehensive.
Other bias	Unclear risk	Insufficient information to assess whether an additional risk of bias exists.

Characteristics of excluded studies [ordered by study ID]

Study	Reason for exclusion
Clifton 1998	Not on interventions to reduce anxiety.
Cruickshank 2005	Randomised, double blind parallel group design. Computer randomisation numbers generated. Block allocation 396 women with CIN attending colposcopy clinic for loop excision biopsy. However this trial was NOT on intervention to reduce anxiety.
Danhauer 2007	RCT comparing music or guided imagery versus usual care for women undergoing colposcopy. However, 32% of 170 women in the trial had received previous colposcopy.
French 2004	This was not a randomised controlled trial
Greimel 1997	Quasi‐randomised trial which included 147 women with cervical abnormalities attending colposcopy clinic for the first time. Women with previous diagnosis of smear abnormalities and women who had hysterectomy were excluded. The trial compared information given verbally without teaching aids, information given verbally and in graph form, verbal information with information video of colposcopy and women who were given information only if they asked for it (control group).
Johnson 1989	Not an interventions to reduce anxiety.
Kitchener 2004	Not an interventions to reduce anxiety. The control group had a smear at their GP practice.
Peters 1999	This study did not investigate an intervention to reduce anxiety.
Philips 2002	Not treatment for anxiety
Rickert 1994	Two studies (randomised) reported in one paper, but patients included adolescent females between the age of 13‐20 years, so a substantial number would have been under the age of 18 years. The anxiety scales were self reported and no validated scale such as STAI was used.
Sarkar 1993	Quasi‐randomised trial comparing counselling with no counselling at a colposcopy clinic. The primary objectives of this trial were to assess the emotional well‐being of women with a positive smear.
Tomaino‐Brunner 1998	Quasi‐randomised trial which included 103 women attending colposcopy for the first time. The trial compared information leaflets (given to women in intervention group one week before colposcopy) with no information leaflet.
Walsh 2004	Quasi‐randomised trial which included 81 women between 20 and 40 years of age, with abnormal smears attending colposcopy for the first time. The trial compared video colposcopy where the participant was able to observe a monitor presenting real time images of the cervix during procedure with no video colposcopy.

Differences between protocol and review

Quasi‐RCTs were included in the original version of the review but were subsequently removed when the review was updated. The methods section was also adapted in accordance to the latest version of the Cochrane handbook.

Contributions of authors

In the original protocol and review:

Khadra Galaal and Shubha Sangal provided clinical expertise and helped design the protocol. Khadra Galaal was the primary author of the protocol and the review. Khadra Galaal and Katherine Dean completed the review. A Lopes provided clinical expertise and helped in the analysis, discussion and interpretation of the review findings. Katherine Deane provided systematic review methodological expertise and advice at all stages.

In the updated version of the review:

Khadra Galaal provided clinical expertise, sifted the updated searches, completed data extraction and revised the clinical sections of the review in accordance with RevMan 5. Maha Al‐Khaduri reviewed the papers and assisted in writing the updated version of the review. Andrew Bryant revised the methods section of the review in accordance with the latest version of the handbook, sifted the updated searches, completed data extraction and revised the methodological and statistical sections of the review.

Sources of support

Internal sources

• Northern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Gateshead, UK

External sources

• Department of Health, UK

  NHS Cochrane Collaboration programme Grant Scheme CPG‐506

Declarations of interest

None known.

Edited (no change to conclusions)