Abstract
Background
Seclusion and restraint are interventions used in the treatment and management of disruptive and violent behaviours in psychiatry. The use of seclusion varies widely across institutions. The literature does offer numerous suggestions for interventions to reduce or prevent aggression.
Objectives
1. To estimate the effects of seclusion and restraint compared to the alternatives for those with serious mental illnesses. 2. To estimate the effects of strategies to prevent seclusion and restraint in those with serious mental illnesses.
Search methods
Electronic searches of The Cochrane Controlled Trials Register (Issue 1, 1999) and The Cochrane Schizophrenia Group's Register (January 1999) were supplemented with additional searches of Biological Abstracts (1989‐1999), CINAHL (1982‐1999), EMbase (1980‐1999), MEDLINE (1966‐1999), MEDIC (1979‐1999), PsycLIT (1974‐1999), Sociofile (1974‐1999), SPRI & SWEMED (1982‐1999), Social Sciences Citation Index (1996‐1999), and WILP (1983‐1999). In addition, trials were sought by hand searching the reference lists of all identified studies and conference abstracts and contacting the first author of each relevant study.
We updated this search 10 May 2012 and added the results to the awaiting classification section of the review.
Selection criteria
Randomised controlled trials were included if they focused on the use (i) of restraint or seclusion; or (ii) of strategies designed to reduce the need for restraint or seclusion in the treatment of serious mental illness.
Data collection and analysis
Studies were reliably selected, quality rated and data extracted. For dichotomous data relative risks (RR) with 95% confidence intervals (CI) were estimated. Normal continuous data were summated using the weighted mean difference (WMD).
Main results
1. Effect of seclusion and restraint The search strategy yielded 2155 citations. Of these, the full articles for 35 studies were obtained. No studies met minimum inclusion criteria and no data were synthesised. Most of the 24 excluded studies focused upon the restraint of elderly, confused people and preventing them from wandering or falling.
2. Prevention of seclusion and restraint Work ongoing.
3. Update search 2012: the 2 new citations in the awaiting classification section of the review may alter the results and conclusions of the review once assessed.
Authors' conclusions
No controlled studies exist that evaluate the value of seclusion or restraint in those with serious mental illness. There are reports of serious adverse effects for these techniques in qualitative reviews. Alternative ways of dealing with unwanted or harmful behaviours need to be developed. Continuing use of seclusion or restraint must therefore be questioned from within well‐designed and reported randomised trials that are generalisable to routine practice.
Keywords: Humans; Patient Isolation; Restraint, Physical; Antipsychotic Agents; Antipsychotic Agents/therapeutic use; Mental Disorders; Mental Disorders/drug therapy; Mental Disorders/therapy
Plain language summary
Seclusion and restraint for people with serious mental illnesses
Synopsis pending.
Background
Seclusion and restraint are interventions used in the treatment and management of disruptive and violent behaviours in psychiatry (APA 1985). Seclusion is the placement and retention of an inpatient in a bare room for containing a clinical situation that may result in a state of emergency. Restraint involves measures designed to confine a patient's bodily movements (Gutheil 1995). Seclusion and restraint are suggested to prevent injury and reduce agitation, but the use of seclusion and restraint can have substantial deleterious physical and more often psychological effects on both the patient and the staff (Fisher 1994). It is claimed that seclusion and restraint reduce agitation and prevent injury (Gerlock 1983).
The theoretical foundations of seclusion, much debated in the literature, are based on whether it is a valid therapeutic intervention in itself, merely a method of containment of a psychiatric emergency or a form of punishment (Mason 1993). The reviewers know of no literature discussing differences between seclusion and restraint. The effect of these interventions on the frequency of aggressive incidents is not known (Nijman 1997).
The use of seclusion varies widely across institutions from 0 to 66% (Brown 1992). In a single group of state psychiatric hospitals, all operating the same policies and procedures, considerable variation in the rates of seclusion and restraint were found (Way 1990). Hospitals with high use had a rate more than three times greater than hospitals with low usage. The rate of seclusion and restraint in the 23 hospitals ranged from 0.4 to 9.4% of patients. Only some of the differences between hospitals could be explained by patient characteristics and a large 'facility effect' was found (Way 1990). The least restrictive principle is inconsistently used, and creative alternatives to confinement are not always employed (Aschen 1995). There are only very few studies that calculate the relative risk of seclusion and restraint in different populations (Höyer 1994) and the characteristics of secluded or restraint patients also differ widely from one study to another (Swett 1994, Walsh 1995). In addition, there are reports of patients treated effectively with no use or very little use of restraint and seclusion in many psychiatric settings (Ray 1995).
In some follow‐up studies, despite political changes and changes in the size and mission of hospitals, rates of seclusion and restraint have not changed (Crenshaw 1997, Salib 1998). This has been used as evidence to show that seclusion of some disturbed patients will inevitably continue to be used. Further it has been suggested that when a patient cannot co‐operate and is at a risk of being dangerous to himself or others seclusion may be the safest and most dignified intervention, especially if there are concerns arising from the patient's medical or psychiatric history (Farnham 1997). Yet, few other forms of treatment which are applied to patients with various psychiatric diagnoses are so lacking in basic information about their proper use and efficacy (Angold 1989).
Violent incidents in psychiatric settings are frequent, serious, underreported and may be an increasing problem (Shah 1991). They do not happen at random and warning signs often exist. These signs may, however, be difficult to identify and interpret (Owen 1998). Three means of controlling violence are verbal de‐escalation, medication and/or physical restraint (Tardiff 1992). The literature does offer numerous suggestions for aggression‐reducing and preventing interventions. These include for instance suggestions for medication, staff training programs, approaches developed to de‐escalate threatening situations, behavioral modifications methods and others (Chow 1996, Essock 1996, McDonnell 1996, Whittington 1996, Kalogjera 1989, Phillips 1995). Relatively little is known about the effects of these interventions on the frequency of aggressive incidents (Nijman 1997).
Objectives
1. To estimate the effects of seclusion and restraint measured against 'standard care or other alternative interventions for treating people who are violent or a serious danger to themselves or others. It was also proposed to identify any effects of the different techniques for staff. 2. To estimate the effects of strategies used to prevent the use of seclusion and restraint of mentally ill people.
Methods
Criteria for considering studies for this review
Types of studies
1. Effects of seclusion and restraint All relevant randomised controlled trials of seclusion and restraint.
2. Prevention of seclusion and restraint All relevant randomised controlled trials of strategies used to reduce the need for seclusion or restraint.
Types of participants
1. Effects of seclusion and restraint People with serious or chronic mental illness. People with dementia, or people who were likely to be suffering from dementia or cognitive impairment caused by illness other than psychotic disorders, were, where possible, excluded from this part of the review. Trials primarily focusing on restraining older people to prevent them from wandering were also excluded.
2. Prevention of seclusion and restraint Anybody who is the focus of a strategy with the primary focus of prevention of seclusion and restraint. As such strategies may not be patient focused, the following participants are included: (i) staff; (ii) organisations; (iii) people with serious or chronic mental illness. Interventions that aim to reduce the use of seclusion or restraint in the treatment of those whose main problems are learning difficulties, dementia, or drug and alcohol abuse were excluded.
Types of interventions
1. Effects of seclusion and restraint measured against 'standard care' or other alternative interventions a. Seclusion: containment of the patient alone in a room or other enclosed area from which the patient has no means of freely leaving the area. This does not include the use of locked wards. b. Restraint: restricting the patient's ability to move by using different devices designed for this purpose or holding the patient down by physical force. c. Standard care: care delivered under current custom and practice of the unit where the interventions were being compared, not including seclusion or restraint.
2. Prevention of seclusion and restraint a. Educational strategies; b. behavioural strategies; c. any alternative response to seclusion or restraint; d. changes in policy; e. medication; f. administrative measures; or g. standard care: defined as care delivered under current custom and practice of the unit where the interventions were being compared.
Types of outcome measures
Outcomes were grouped according to time periods: immediate (up to one week), short term (from one week to less than one month), medium term (1‐6 months) and long term (more than six months).
Primary outcomes
Effects of seclusion and restraint The outcome measures used in each trial were all described.
The primary outcomes of interest were: 1. Mental state 1.1 Clinically significant change as defined in individual studies 1.2 Continuous measures of mental state.
2. Behaviour 2.1 Violent or aggressive behaviour
3. Adverse effects 3.1 Physical adverse effects 3.2 Death, suicide or by other causes 3.3 Psychological adverse effects
4. Medication 4.1 Use of antipsychotic medication 4.2 Parental administration 4.3 Use of minor tranquilizers 4.4 Parental administration
5. Hospitalization 5.1 Length of hospital stay 5.2 Changes in hospital status
6. Satisfaction with care 6.1 Patient satisfaction 6.2 Carer satisfaction
7. Economic outcomes
Restraint and seclusion are primarily interventions used in response to an urgent need. Outcomes were grouped according to time periods: short term (less than one hour), medium term (1‐12 hours) and long term (more than 12 hours).
Prevention of seclusion and restraint The outcome measures used in each trial were described.
The primary outcomes of interest were: 1. Changes in levels of seclusion and restraint.
Secondary outcomes
The secondary outcomes of interest were
1. Changes in symptoms 1.1. Violent or aggressive behaviour 1.2. Psychiatric symptoms
2. Adverse effects 2.1. Physical adverse effects 2.1.1. Death, by suicide or other causes 2.2. Psychological adverse effects
3. Medication 3.1. Use of antipsychotic medication 3.1.1. Parental administration 3.2. Use of minor tranquilizers 3.2.1. Parental administration
4. Hospitalization 4.1. Length of hospital stay 4.2. Changes in hospital status
5. Satisfaction with care 5.1. Patient satisfaction 5.2. Carer satisfaction
6. Economic outcomes
Search methods for identification of studies
Electronic searches
1. Electronic searching In a first phase relevant randomised trials were identified by searching the following two electronic databases: 1.1 The Cochrane Controlled Trials Register (Issue 1, 1999) was searched using the phrase:
COERCION or COERCIVE* or COMPULSOR* or INVOLUNTA* or RESTRAI* or SECLU* or ((IMMOBILI* or ISOLATION) and (PSYCH* or SCHIZO* or AGGRESSI* or MENTAL* or MENTAL‐DISORDERS*:ME)) or COERCION*:ME or COMMITMENT‐OF‐MENTALLY‐ILL*:ME or RESTRAINT‐PHYSICAL*:ME or (PATIENT‐ISOLATION*:ME not BACTERIAL‐INFECTIONS‐OR‐MYCOSES*:ME).
1.2 Cochrane Schizophrenia Group's Register (January 1999) was searched using the phrase:
COERCION or COERCIVE* or COMPULSOR* or IMMOBILI* or INVOLUNTA* or ISOLATION or RESTRAI* or SECLU*
1.3 Biological Abstracts (January 1989 to May 1998) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCION or COERCIVE* or COMPULSOR* or INVOLUNTA* or RESTRAI* or SECLU* or (IMMOBILI* or ISOLATION))]
1.4 CINAHL (1982 to August 1998) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCI* or COMPULS* or INVOLUNTA* or RESTRAI* or SECLU* or ((CONTAIN* or LOCK* or PADDED near1 ROOM) and (PSYCH*)) or (TIME near1 OUT) or ((SOCIAL near1 CONTROL) and (FORMAL or INFORMAL)))]
1.5 EMbase (January 1980 to November 1998) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCI* or COMPULS* or INVOLUNTA* or SECLU* or RESTRAI* or explode "INVOLUNTARY‐COMMITMENT"/ all subheadings or ((CONTAIN* or LOCK* or PADDED) near1 ROOM) or (PATIENT near1 ISOLATION) or (PIN near1 DOWN) or (TIME near1 OUT) or ((SOCIAL near1 CONTROL) and (FORMAL or INFORMAL)) or explode "INVOLUNTARY‐COMMITMENT"/ all subheadings)]
1.6 MEDLINE (January 1966 to May 1998) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCI* or COMPULSOR* or (INVOLUNTA* not MOVEMENT) or SECLU* or (RESTRAI* not ANIMAL) or explode COERCION(MeSH)/all subheadings or explode COMMITMENT‐OF‐MENTALLY‐ILL(MeSH)/all subheadings or (explode RESTRAINT‐PHYSICAL(MeSH)/all subheadings and HUMAN(MeSH)) or explode PATIENT‐ISOLATION(MeSH)/all subheadings or ((CONTAIN* or LOCK* or PADDED) near1 ROOM) or ((SOCIAL near1 CONTROL) and (FORMAL or INFORMAL)) or ((PATIENT near1 ISOLATION) and (MENTAL or PSYCH* or AGGRESSI* or SCHIZO*)))]
1.7 MEDIC, a Finnish medical database (1979 to May 1998) was searched with the phrase:
(CLINICAL TRIALS or RANDOMIS or KONTROLLOI or SATUNNAISTET or VERTAIL or HOITOKO) and (ERIST or PAKKO or LEPOSI or COERCION or COMMITMENT or ISOLATION or RESTRAINT)
1.8 PsycLIT (January 1974 to December 1997) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (SECLU* or "PATIENT‐SECLUSION" or (RESTRAI* not DIET) or "PHYSICAL‐RESTRAINT" or COERCI* or COMPULSOR* or (INVOLUNTA* not MOVEMENT) or "INVOLUNTARY‐TREATMENT" or IMMOBILI* or (PATIENT* near1 SECLU*) or "COMMITMENT OF MENTALLY ILL" or PATIENT‐ISOLATION)]
1.9 Sociofile (1974 to December 1997) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (SECLU* or RESTRAI* or COERCI* or COMPULSO* or INVOLUNTA* or IMMOBILI*or(PATIENT* and ISOLAT*))]
1.10 SPRI (a Swedish database for health technology assessment and research and development) and SWEMED (a medical database covering Sweden and Norway) (1982 to May 1998).
(CLINICAL TRIALS(MeSH) or RANDOMIS or KONTROLLGRUPP or KONTROLLERAD or BEHANDLINGSSTUDIE) and (TVÅNG or TVANG or RUMSRESTRIKTION or FRIHETSBERÖVANDE or *BÄLTE* or ISOLERING* or COERCION or COMMITMENT or ISOLATION or RESTRAINT)
1.11 Social Sciences Citation Index (SSCI) (January 1996 to July 1998) was searched using the phrase:
(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*) and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and (SECLU* or RESTRAI* or COERCIVE* or COERCION* or COMPULSOR* or INVOLUNTA* or IMMOBILI* or PATIENT‐ISOLATION)
1.12 WILP (Wilson Index to Legal Periodicals) (1983 to May 1998) was searched with the phrase:
COERCIVE* or COERCION or COMPULSOR* or INVOLUNTA* or RESTRAI* or SECLU* or (IMMOBILI* and (PSYCH* or SCHIZO* or AGGRESSI* or MENTAL*)) or (PATIENT and ISOLATION)
Prevention of seclusion and restraint
2. Electronic searching In a first phase relevant randomised trials were identified by searching the following two electronic databases:
2.1 THE COCHRANE LIBRARY CENTRAL Issue 4, 1999, was searched using the phrase:
[explode ("Aggression"/ all subheadings) or (explode "Violence"/ all subheadings) or ("Dangerous‐Behavior") or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.2 COCHRANE SCHIZOPHRENIA GROUP'S REGISTER (October 1999) was searched using the phrase:
[violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) and (behav* or action* or conduct*))]
Conference abstracts were sought from within the Cochrane Schizophrenia Groups Register. After the trials were selected and the review was ongoing, other databases were investigated:
2.3 BIOLOGICAL ABSTRACTS/RRM (January 1989 to August 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.4 CINAHL (1982 to August 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [(explode "Aggression"/ all topical subheadings/ all age subheadings) or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.5 EMBASE (January 1980 to August 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [(explode "Aggression"/ all subheadings) or (explode "Violence"/ all subheadings) or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.6 MEDLINE (January 1966 to May 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [(explode "Aggression"/ all subheadings) or (explode "Violence"/ all subheadings) or ("Dangerous‐Behavior") or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.7 PSYCLIT (January 1974 to May 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [(explode "Aggression") or (explode "Violence") or ("Dangerousness‐in DE") or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.8 SOCIOFILE (1974 to May 1999) was searched using the phrase used to identify articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*) and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and (AGGRESSI* or VIOLEN* or AGITA* or ((DANGER* or BIZARRE*) and BEHAV*)
2.9 Social Sciences Citation Index (SSCI) (Jan 1996 to Jul 1999) was searched using the phrase used to identify articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase: (RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*) and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and (AGGRESSI* or VIOLEN* or AGITA* or ((DANGER* or BIZARRE*) and BEHAV*)
3. Cochrane Schizophrenia Group’s Trials Register (May 2012) We updated this search 10 May 2012. The Trials Search Co‐ordinator searched the Cochrane Schizophrenia Group’s Trials Register. The Cochrane Schizophrenia Group’s Trials Register is compiled by systematic searches of major databases, handsearches and conference proceedings (see group module).
Trials identified through the searching activities are each assigned to awaiting classification of relevant review titles.
Searching other resources
1. Reference searching The references of all identified studies were also inspected for more trials. Science Citation Index (SCI) and Social Sciences Citation Index (SSCI) (1974 to May 1999) was used to trace papers that had cited included trials. These reports were inspected in order to identify further trials. SciSearch and Social SciSearch (1974 to May 1998) were to be used to trace papers that had cited included trials. These reports were to be inspected in order to identify further trials.
2. Personal contact The first author of each included study was contacted for information regarding unpublished trials.
Data collection and analysis
[For definitions of terms used in this, and other sections, please refer to The Cochrane Library Glossary.]
1. Selection of trials for the review The title and abstract of each reference identified by the search was inspected independently by both reviewers to assess its relevance. Where disagreement between the two reviewers occurred, the full article was obtained. Relevance was again assessed independently by both reviewers. Again, where disagreement occurred this was resolved by discussion and when this was not possible, further information was sought. These trials were added to the list of those awaiting assessment pending acquisition of further information.
2. Assessment of the methodological quality of the included trials. The criteria included in the Cochrane Collaboration Handbook (Mulrow 1999) was used to assess the quality of the trials. It is based on the evidence of a strong relationship between the potential for bias in results and the concealment of allocation and is defined as below: A. Low risk of bias (adequate allocation concealment); B. Moderate risk of bias (some doubt about the results); C. High risk of bias (inadequate allocation concealment). Trials were included if they met the criteria A or B on this quality criteria. The Jadad Scale (Jadad 1996) was used to give a second quality rating to the relevant trials.
3. Data collection Data from selected trials were independently extracted by both reviewers. When disputes arose, resolution was attempted by discussion. When this was not possible and further information was necessary to resolve the disagreement, the decisions documented and where necessary, the authors of the studies were contacted for clarification. Justification for excluding references from the review was documented.
4. Data synthesis 4.1 Incomplete data. With the exception of the outcome of leaving the study early, trial outcomes were not included if more than 40% of people were not reported in the final analysis.
4.2 Dichotomous ‐ yes/no ‐ data. As long as over 60% of people completed the study, everyone allocated to the intervention was counted, whether they completed the follow up or not. It was assumed that those who dropped out had the negative outcome, with the exception of death.
Relative risk (RR) and 95% confidence interval (CI) were calculated. If outcomes were heterogeneous calculations were based on the random effects model, as it takes into account any differences between studies. If outcomes were homogeneous, a fixed effects model was applied. Data were inspected to see if analysis using a Mantel Haenszel odds ratio made any substantive difference. Where possible, number needed to treat (NNT) was estimated from the weighted pooled relative risk estimate.
4.3 Continuous data. 4.3.1 Rating scales: A wide range of instruments are available to measure mental health outcomes. These instruments vary in quality and many are not valid, or even ad hoc. For outcome instruments minimum standards were set. They were that the psychometric properties of the instrument should have been described in a peer‐reviewed journal. 4.3.2 Normal data: Mental health continuous data is often not 'normally' distributed. To avoid the pitfall of applying parametric tests to non‐parametric data the following standards were applied to all data before inclusion: i. standard deviations and means were reported in the paper or were obtainable from the authors; ii. if the data were scale‐derived, or finite measures from, for example 0‐100, the standard deviation was multiplied by two. If the result was less than the mean (as otherwise the mean was unlikely to be an appropriate measure of the centre of the distribution (Altman 1996) data were included in meta‐analysis and presented in graphical form. Data not meeting these standards were reported in the 'Other data types' of the 'Results' section if they had been analysed with appropriate non‐parametric tests.
5. Heterogeneity Heterogeneity in the results of the trials was assessed both by inspection of graphical presentations and by calculating a chi‐square test of heterogeneity. If heterogeneity was present any underlying explanation was sought. The reviewers undertook a sensitivity analysis to the presence or absence of these data. All data from studies that have been selected were presented.
6. Addressing publication bias Data from all identified and selected trials were entered into a funnel graph (trial effect versus trial size) in an attempt to investigate the likelihood of overt publication bias.
7. Tables and figures Where possible data were entered into RevMan in such a way that the area to the left of the line of no effect indicates a favourable outcome for the intervention of interest.
Results
Description of studies
1. Effects of seclusion and restraint
Excluded studies All 24 identified studies were excluded. For the full description of why these studies were not included, please see the Excluded studies table. Most did not meet minimum inclusion criteria for their methods, participants or interventions of interest. Most focused upon the restraint of elderly and confused people and on preventing wandering or falling.
Ten studies focused on restraining elderly people with either organic problems or physical ill health. Another was a preliminary report of a trial of room design to aid confused, physically ill people and a further two, investigating the value of restraining elderly confused people, did not use a control.
Four trials did not focus on interventions of interest ‐ either adequate medication or psychosocial environments. A single randomised experiment focused on staff attitudes to using electric shocks of people before and after watching a video of a violent person and another investigated the value of different restraint techniques on healthy volunteers. One randomised trial of a single person investigated the value of different protective clothing on a 13‐year‐old adolescent with profound learning difficulties, and finally, four were surveys.
2. Prevention of seclusion and restraint Work underway.
3. Studies awaiting classification There are 2 studies awaiting classification (Bergk 2011; ISRCTN49454276).
Risk of bias in included studies
1. Effects of seclusion and restraint No trials were able to be included.
2. Prevention of seclusion and restraint Work underway.
Effects of interventions
1. Effects of seclusion and restraint
Search The search strategy yielded 2155 citations. The Cochrane Controlled Trials Register yielded 1018 citations, the Cochrane Schizophrenia Group's Register 126, Biological Abstracts 207, CINAHL 48, EMbase 360, MEDIC zero, MEDLINE 123, PsycLIT 215, Sociofile 27, SPRI & SWEMED one, SSCI 70 and WILP zero. Of these, the full articles for 35 studies were obtained. These same articles came up in several databases (The Cochrane Library CENTRAL, MEDLINE, CINAHL and PsycLIT). From these citations, 18 studies for potential inclusion were identified. No relevant additional studies were found by searching the references of excluded studies.
Lack of data No studies using restraint or seclusion as an intervention measure in the treatment of psychiatric emergencies were found, but four studies had seclusion or restraint as an outcome. Not one paper fulfilled the pre‐stated criteria of the reviewers. As has been discussed above, most studies focused on restraining elderly people with psycho‐organic problems or physical ill health in order to prevent them from falling or wandering. There is a surprising and shocking lack of published trials assessing the effects of secluding or restraining people with schizophrenia or similar psychotic illnesses.
2. Prevention of seclusion and restraint Work underway.
Discussion
The reviewers acknowledge the very great difficulty of carrying out controlled trials in people with challenging behaviours. Nevertheless, the complete lack of trial‐derived evidence regarding the effects of seclusion and restraint is surprising given the invasiveness of the intervention and its continued use over time. This dearth may highlight a belief that they are such effective, satisfactory interventions that there is not the need for evaluation in randomised trials. Counter to this is that certain researchers, not satisfied with the effects or nature of seclusion and restraint, have attempted to find creative alternatives (Nijman 1997).
Randomising different techniques of seclusion and restraint, or comparing the former to alternatives, may be thought to be controversial. Conversely, continuing to use a poorly investigated set of 'invasive' treatments on very significant numbers of people (Way 1990) may seem equally questionable.
Three studies were found that reported an improvement in control of aggression with adequate medication (Chow 1996, Essock 1996, Sommerness 1957). Another trial used a psychosocial programme to reduce the number of episodes of seclusion (Gudeman 1981). These trials are not included in the review of effects of seclusion and restraint as they were not the primary interventions of interest. These will be included in the amended review, including also interventions aimed at reducing need for seclusion and restraint in those with serious mental illness.
Authors' conclusions
Implications for practice.
In the absence of any controlled trials in those with serious mental illness, no recommendation can be made about the effectiveness, benefit or harmfulness of seclusion or restraint. In view of data from non‐randomised studies, use should be minimised for ethical reasons. The use of seclusion or restraint should only be continued in the context of simple, pragmatic randomised trials given the marked variation between institutions and reports of harm in qualitative reviews.
No controlled studies to support the continued use of seclusion or restraint in clinical practice were found. As there are reports of serious adverse effects reported in qualitative reviews (Fisher 1994), randomised controlled trials are needed to test the benefits and harms of seclusion and restraint. Attempts must be made to find alternative methods of dealing with unwanted behaviours.
For those with serious mental illness and their relatives No evidence exists to support or refute the use of these interventions. Although seclusion and restraint techniques are undoubtedly unpleasant, as strategies for preventing assault to others or harm to oneself, these containing treatments may still be both practical and safe. On the other hand, the use of seclusion and restraint could lead to greater morbidity and mortality than alternative drug or non‐drug approaches. Those with serious mental illness and their relatives could well pre‐specify which technique they would find preferable should their mental state or behaviour seriously deteriorate.
For practitioners In the absence of any relevant controlled trials, no trial‐based recommendations can be made about the effects of seclusion or restraint. In view of data from non‐randomised studies, use should be minimised for ethical reasons (Fisher 1994). It is arguable that, except for extreme circumstances, the use of seclusion or restraint should only be continued in the context of simple, pragmatic randomised trials.
Implications for research.
Seclusion and restraint are used in the hope of preventing injury and reducing agitation, but qualitative studies have reported substantial deleterious physical, and, more often, psychological effects on both patients and staff (Fisher 1994). Randomised studies are urgently needed. These could compare seclusion and restraint and other interventions such as adequate medication, alternative environments, psychosocial interventions or staff education. Randomised trials should be well planned, executed and reported. Randomising people recognisable in routine practice to generalisable interventions, and measuring simple, clinically relevant outcomes would greatly increase the value of these trials.
What's new
| Date | Event | Description |
|---|---|---|
| 10 May 2012 | Amended | Update search of Cochrane Schizophrenia Group's Trial Register (see Search methods for identification of studies), 2 studies (Bergk 2011; ISRCTN49454276) added to awaiting classifciation. |
History
Protocol first published: Issue 3, 1998 Review first published: Issue 2, 1999
| Date | Event | Description |
|---|---|---|
| 31 October 2008 | Amended | Converted to new review format. |
Notes
Cochrane Schizophrenia Group internal peer review complete (see Module). External peer review scheduled.
Acknowledgements
The reviewers would like to thank Kristian Wahlbeck for his editorial comments.
Appendices
Appendix 1. Previous searches
1. Electronic searching In a first phase relevant randomised trials were identified by searching the following two electronic databases: 1.1 The Cochrane Controlled Trials Register (Issue 1, 1999) was searched using the phrase:
COERCION or COERCIVE* or COMPULSOR* or INVOLUNTA* or RESTRAI* or SECLU* or ((IMMOBILI* or ISOLATION) and (PSYCH* or SCHIZO* or AGGRESSI* or MENTAL* or MENTAL‐DISORDERS*:ME)) or COERCION*:ME or COMMITMENT‐OF‐MENTALLY‐ILL*:ME or RESTRAINT‐PHYSICAL*:ME or (PATIENT‐ISOLATION*:ME not BACTERIAL‐INFECTIONS‐OR‐MYCOSES*:ME).
1.2 Cochrane Schizophrenia Group's Register (January 1999) was searched using the phrase:
COERCION or COERCIVE* or COMPULSOR* or IMMOBILI* or INVOLUNTA* or ISOLATION or RESTRAI* or SECLU*
1.3 Biological Abstracts (January 1989 to May 1998) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCION or COERCIVE* or COMPULSOR* or INVOLUNTA* or RESTRAI* or SECLU* or (IMMOBILI* or ISOLATION))]
1.4 CINAHL (1982 to August 1998) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCI* or COMPULS* or INVOLUNTA* or RESTRAI* or SECLU* or ((CONTAIN* or LOCK* or PADDED near1 ROOM) and (PSYCH*)) or (TIME near1 OUT) or ((SOCIAL near1 CONTROL) and (FORMAL or INFORMAL)))]
1.5 EMbase (January 1980 to November 1998) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCI* or COMPULS* or INVOLUNTA* or SECLU* or RESTRAI* or explode "INVOLUNTARY‐COMMITMENT"/ all subheadings or ((CONTAIN* or LOCK* or PADDED) near1 ROOM) or (PATIENT near1 ISOLATION) or (PIN near1 DOWN) or (TIME near1 OUT) or ((SOCIAL near1 CONTROL) and (FORMAL or INFORMAL)) or explode "INVOLUNTARY‐COMMITMENT"/ all subheadings)]
1.6 MEDLINE (January 1966 to May 1998) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (COERCI* or COMPULSOR* or (INVOLUNTA* not MOVEMENT) or SECLU* or (RESTRAI* not ANIMAL) or explode COERCION(MeSH)/all subheadings or explode COMMITMENT‐OF‐MENTALLY‐ILL(MeSH)/all subheadings or (explode RESTRAINT‐PHYSICAL(MeSH)/all subheadings and HUMAN(MeSH)) or explode PATIENT‐ISOLATION(MeSH)/all subheadings or ((CONTAIN* or LOCK* or PADDED) near1 ROOM) or ((SOCIAL near1 CONTROL) and (FORMAL or INFORMAL)) or ((PATIENT near1 ISOLATION) and (MENTAL or PSYCH* or AGGRESSI* or SCHIZO*)))]
1.7 MEDIC, a Finnish medical database (1979 to May 1998) was searched with the phrase:
(CLINICAL TRIALS or RANDOMIS or KONTROLLOI or SATUNNAISTET or VERTAIL or HOITOKO) and (ERIST or PAKKO or LEPOSI or COERCION or COMMITMENT or ISOLATION or RESTRAINT)
1.8 PsycLIT (January 1974 to December 1997) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (SECLU* or "PATIENT‐SECLUSION" or (RESTRAI* not DIET) or "PHYSICAL‐RESTRAINT" or COERCI* or COMPULSOR* or (INVOLUNTA* not MOVEMENT) or "INVOLUNTARY‐TREATMENT" or IMMOBILI* or (PATIENT* near1 SECLU*) or "COMMITMENT OF MENTALLY ILL" or PATIENT‐ISOLATION)]
1.9 Sociofile (1974 to December 1997) was searched using the Cochrane Schizophrenia Group's phrase for both randomised controlled trials and schizophrenia (see Group search strategy) combined with the phrase:
[and (SECLU* or RESTRAI* or COERCI* or COMPULSO* or INVOLUNTA* or IMMOBILI*or(PATIENT* and ISOLAT*))]
1.10 SPRI (a Swedish database for health technology assessment and research and development) and SWEMED (a medical database covering Sweden and Norway) (1982 to May 1998).
(CLINICAL TRIALS(MeSH) or RANDOMIS or KONTROLLGRUPP or KONTROLLERAD or BEHANDLINGSSTUDIE) and (TVÅNG or TVANG or RUMSRESTRIKTION or FRIHETSBERÖVANDE or *BÄLTE* or ISOLERING* or COERCION or COMMITMENT or ISOLATION or RESTRAINT)
1.11 Social Sciences Citation Index (SSCI) (January 1996 to July 1998) was searched using the phrase:
(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*) and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and (SECLU* or RESTRAI* or COERCIVE* or COERCION* or COMPULSOR* or INVOLUNTA* or IMMOBILI* or PATIENT‐ISOLATION)
1.12 WILP (Wilson Index to Legal Periodicals) (1983 to May 1998) was searched with the phrase:
COERCIVE* or COERCION or COMPULSOR* or INVOLUNTA* or RESTRAI* or SECLU* or (IMMOBILI* and (PSYCH* or SCHIZO* or AGGRESSI* or MENTAL*)) or (PATIENT and ISOLATION)
Prevention of seclusion and restraint
2. Electronic searching In a first phase relevant randomised trials were identified by searching the following two electronic databases:
2.1 THE COCHRANE LIBRARY CENTRAL Issue 4, 1999, was searched using the phrase:
[explode ("Aggression"/ all subheadings) or (explode "Violence"/ all subheadings) or ("Dangerous‐Behavior") or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.2 COCHRANE SCHIZOPHRENIA GROUP'S REGISTER (October 1999) was searched using the phrase:
[violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) and (behav* or action* or conduct*))]
Conference abstracts were sought from within the Cochrane Schizophrenia Groups Register. After the trials were selected and the review was ongoing, other databases were investigated:
2.3 BIOLOGICAL ABSTRACTS/RRM (January 1989 to August 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.4 CINAHL (1982 to August 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [(explode "Aggression"/ all topical subheadings/ all age subheadings) or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.5 EMBASE (January 1980 to August 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [(explode "Aggression"/ all subheadings) or (explode "Violence"/ all subheadings) or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.6 MEDLINE (January 1966 to May 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [(explode "Aggression"/ all subheadings) or (explode "Violence"/ all subheadings) or ("Dangerous‐Behavior") or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.7 PSYCLIT (January 1974 to May 1999) was searched using the both phrases used to identify randomised controlled trials and articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
AND [(explode "Aggression") or (explode "Violence") or ("Dangerousness‐in DE") or violen* or aggressi* or attack* or assault* or agita* or ((danger* or bizarre) near (behav* or action* or conduct*))]
2.8 SOCIOFILE (1974 to May 1999) was searched using the phrase used to identify articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase:
(RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*) and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and (AGGRESSI* or VIOLEN* or AGITA* or ((DANGER* or BIZARRE*) and BEHAV*)
2.9 Social Sciences Citation Index (SSCI) (Jan 1996 to Jul 1999) was searched using the phrase used to identify articles relating to schizophrenia as published in the Cochrane Schizophrenia Group's search strategy combined with the phrase: (RANDOMI* or ((SINGL* or DOUBL* or TREBL* or TRIPL*) and (BLIND* or MASK*)) or CROSSOVER or TRIAL) and (AGGRESSI* or VIOLEN* or AGITA* or ((DANGER* or BIZARRE*) and BEHAV*)
Characteristics of studies
Characteristics of excluded studies [ordered by study ID]
| Study | Reason for exclusion |
|---|---|
| Alessi 1995 | Alllocation: randomised. Participants: elderly (mean age 85 years), mainly problems of urinary incontinence or physically restrained to prevent wandering or falls. Interventions: physical exercise every two hours versus once a day. |
| Buckley 1997 | Allocation: not randomised. Intervention: risperidone. |
| Clark 1995 | Allocation: randomised. Participants: >65 yrs, confused, diagnosis of acute physical illness. Interventions: Dayroom care versus usual care. |
| Cole 1994 | Allocation: randomised. Participants: aged over 75 with delirium (DSM III). Interventions: consultation with geriatric internist and follow up by liaison nurse versus standard medical care. |
| Collard 1985 | Allocation: randomised. Participants: mean age >77 years, primarily with physical illness. Interventions: care in geriatric intensive care unit versus traditional ward. |
| Evans 1997 | Allocation: randomised elderly care homes. Participants: Age over 80, cognitively impaired. Interventions: restraint education versus restraint education and consultation versus no education or consultation. |
| Foxx 1996 | Allocation: randomised. Participants: staff associated with programs serving persons with developmental disabilities. Intervention: video of a violent person versus no video. |
| Frank 1996 | Allocation: not randomised, review article. |
| Gaebler 1994 | Allocation: not randomised, survey of incidence of restraint in the elderly. |
| Glazer 1998 | Allocation: not randomised, survey of aggressive incidents in trials of clozapine. |
| Janelli 1997 | Allocation: not randomised, case control. Participants: elderly people restrained to prevent falls or wandering Intervention: music through headphones versus no music. |
| Lewis 1996 | Allocation: randomised. Participants: people with severe and profound mental retardation. Interventions: clomipramine versus placebo. |
| Moretz 1995 | Allocation: unclear, preliminary report. Participants: over 70 years old, mentally impaired. Intervention: restraint free room, no obvious control. |
| Nijman 1997 | Allocation: not randomised.
Participants: those admitted to a locked unit.
Interventions: protocol for talking to participants who were displaying aggressive behaviour, discussing treatment goals, explaining why the ward door was locked, providing a shedule of staff mettings, and clarifying the procedure for making an appointment with the psychiatrist. This was the one of the few studies that made a comprehensive attempt to try and find alternative psychosocial treatments to seclusion or restraint. |
| Phillips 1995 | Allocation: randomised. Participants: self‐selected male mental health staff. Interventions: didactic training of staff versus didactic training and physical skills versus no training. |
| Roeggla 1997 | Allocation: randomised, cross‐over trial. Participants: healthy male volunteers. Interventions: prone versus upright hobble restraint. |
| Rovner 1996 | Allocation: randomised. Participants: mean age > 81 years, dementia. Interventions: a dementia care program versus usual care. |
| Schnelle 1992 | Allocation: randomised. Participants: mean age 84 years, severely impaired physically and cognitively. Interventions: coloured pads used to indicate the patient had been released from restraint every two hours versus no pads. |
| Schnelle 1996 | Allocation: randomised. Participants: mean age 84 years, participants needed to know their own name or be able to name one of two objects (pen or comb) to be included. Intervention: walking or whell‐chair movement and rowing exercise versus usual care. |
| Silverman 1984 | Allocation: randomised, crossover, N of 1. Participants: one 13 year old profoudly retarded person. Interventions: padded helmet versus padded helmet and padded slippers versus no protective clothing. |
| Stoudemire 1996 | Allocation: not randomised, review. |
| Thapa 1996 | Allocation: not randomised, prevalence survey of injurious falls, prospective cohort study. |
| Thomas 1992 | Allocation: randomised. Participants: violent patients, admitted to emergency department, physically ill mostly with trauma. Interventions: IM haloperidol or droperidol versus IV haloperidol or droperidol. |
| Tutunjian 1963 | Allocation: not randomised, case series. Participants: psychotic female patients. Intervention: peperacetazine, no control. |
| Weinrich 1995 | Allocation: not randomised, review of managing agitation. |
Characteristics of studies awaiting assessment [ordered by study ID]
Bergk 2011.
| Methods | |
| Participants | |
| Interventions | |
| Outcomes | |
| Notes | To be assessed. |
ISRCTN49454276.
| Methods | |
| Participants | |
| Interventions | |
| Outcomes | |
| Notes | To be assessed. |
Contributions of authors
Eila Sailas ‐ initiated the review, prepared protocol, undertook searches, selected and acquired studies, produced report.
Mark Fenton ‐ prepared protocol, undertook searches, selected and acquired studies, produced report.
Sources of support
Internal sources
Department of Psychiatry, University of Helsinki, Finland.
Cochrane Schizophrneia Group, UK.
External sources
Wilhelm and Else Stockmann Foundation, Finland.
STAKES/FinOHTA, Finland.
Declarations of interest
The reviewers believe that seclusion and restraint can be used to excess and that the least restrictive principle is often not sought.
Edited (no change to conclusions)
References
References to studies excluded from this review
Alessi 1995 {published data only}
- Alessi CA, Schnelle JF, MacRae PG, Ouslander JG, Al Samarrai N, Simmons SF, Traub S. Does physical activity improve sleep in impaired nursing home residents?. Journal of the American Geriatric Society 1995;43:1098‐102. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Buckley 1997 {published data only}
- Buckley PF, Ibrahim ZY, Singer B, Orr B, Donenwirth K, Brar PS. Aggression and schizophrenia: efficacy of risperidone. Journal of the American Academy of Psychiatry and the Law 1997;25(2):173‐81. [MEDLINE: ] [PubMed] [Google Scholar]
Clark 1995 {published data only}
- Clark LR, Fraaza V, Schroeder S, Maddens ME. Alternative nursing environments: do they affect hospital outcomes?. Journal of Gerontological Nursing 1995;21:32‐8. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Cole 1994 {published data only}
- Cole MG, Primeau FJ, Bailey RF, Bonnycastle MJ, Masciarelli F, Engelsmann F, Pepin MJ, Ducic D. Systematic intervention for elderly inpatients with delirium: a randomized trial. Canadian Medical Association Journal 1994;151(7):965‐70. [MEDLINE: ] [PMC free article] [PubMed] [Google Scholar]
Collard 1985 {published data only}
- Collard AF, Bachman SS, Beatrice DF. Acute care delivery for the geriatric patient: an innovative approach. QRB Quality Review Bulletin 1985;11:180‐5. [MEDLINE: ] [PubMed] [Google Scholar]
Evans 1997 {published data only}
- Capezuti E, Evans L, Strumpf N, Maislin G. Physical restraint use and falls in nursing home residents. Journal of the American Geriatrics Society 1996;44(6):627‐33. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
- Capezuti E, Strumpf NE, Evans LK, Grisso JA, Maislin G. The relationship between physical restraint removal and falls and injuries among nursing home residents. Journals of Gerontology 1998;53(Series A ‐ Biological Sciences and Medical Sciences):47‐52. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
- Evans LK, Strumpf NE, Allen‐Taylor SL, Capezuti E, Maislin G, Jacobsen B. A clinical trial to reduce restraints in nursing homes. Journal of the American Geriatrics Society 1997;45(6):675‐81. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
- Kolanowski A, Hurwitz S, Taylor LA, Evans L, Strumpf N. Contextual factors associated with disturbing behaviors in institutionalized elders. Nursing Research 1994;43(2):73‐9. [MEDLINE: ] [PubMed] [Google Scholar]
- Patterson JE, Strumpf NE, Evans LK. Nursing consultation to reduce restraints in a nursing home. Clinical Nurse Specialist 1995;9(4):231‐5. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
- Siegler EL, Capezuti E, Maislin G, Baumgarten M, Evans L, Strumpf N. Effects of a restraint reduction intervention and OBRA '87 regulations on psychoactive drug use in nursing homes. Journal of the American Geriatrics Society 1997;45(7):791‐6. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Foxx 1996 {published data only}
- Foxx RM, McHenry IWC, Bremer BA. The effects of a video vignette on increasing treatment acceptability. Behavioral Interventions 1996;11:131‐40. [Google Scholar]
Frank 1996 {published data only}
- Frank C, Hodgetts G, Puxty J. Safety and efficacy of physical restraints for the elderly. Review of the evidence. Canadian Family Physician 1996;42:2402‐9. [MEDLINE: ] [PMC free article] [PubMed] [Google Scholar]
Gaebler 1994 {published data only}
- Gaebler S. Just who do we restrain?. Australian Nursing Journal 1994;2(1):39‐41. [MEDLINE: ] [PubMed] [Google Scholar]
Glazer 1998 {published data only}
- Glazer WM, Dickson RA. Clozapine reduces violence and persistent aggression in schizophrenia. Journal of Clinical Psychiatry 1998;59(Suppl 3):8‐14. [MEDLINE: ] [PubMed] [Google Scholar]
Janelli 1997 {published data only}
- Janelli LM, Kanski GW. Music intervention with physically restrained patients. Rehabilitation Nursing 1997;22(1):14‐9. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Lewis 1996 {published data only}
- Lewis MH, Bodfish JW, Powell SB, Parker DE, Golden RN. Clomipramine treatment for self‐injurious‐behavior of individuals with mental retardation ‐ a double‐blind comparison with placebo. American Journal on Mental Retardation 1996;100(6):654‐65. [MEDLINE: ] [PubMed] [Google Scholar]
Moretz 1995 {published data only}
- Moretz C, Dommel A, Deluca K. Untied: a safe alternative to restraints. Medsurg Nursing 1995;4(2):128‐32. [MEDLINE: ] [PubMed] [Google Scholar]
Nijman 1997 {published data only}
- Nijman HL, Merckelbach HL, Allertz WF, a Campo JM. Prevention of aggressive incidents on a closed psychiatric ward. Psychiatric Services 1997;48(5):694‐8. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Phillips 1995 {published data only}
- Phillips D, Rudestam KE. Effect of nonviolent self‐defense training on male psychiatric staff members' aggression and fear. Psychiatric Services 1995;46(2):164‐8. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Roeggla 1997 {published data only}
- Roeggla M, Wagner A, Muellner M, Bur A, Roeggla H, Hirschl MM, Laggner AN, Roeggla G. Cardiorespiratory consequences to hobble restraint. Wiener Klinische Wochenschrift 1997;109(10):359‐61. [MEDLINE: ] [PubMed] [Google Scholar]
Rovner 1996 {published data only}
- Rovner BW, Steele CD, Shmuely Y, Folstein MF. A randomized trial of dementia care in nursing homes. Journal of the American Geriatrics Society 1996;44(1):7‐13. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Schnelle 1992 {published data only}
- Schnelle JF, Newman DR, White M, Volner TR, Burnett J, Cronqvist A, Ory M. Reducing and managing restraints in long‐term‐care facilities. Journal of the American Geriatrics Society 1992;40(4):381‐5. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Schnelle 1996 {published data only}
- Schnelle JF, MacRae PG, Giacobassi K, MacRae HS, Simmons SF, Ouslander JG. Exercise with physically restrained nursing home residents: maximizing benefits of restraint reduction. Journal of the American Geriatrics Society 1996;44(5):507‐12. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Silverman 1984 {published data only}
- Silverman K, Watanabe K, Marshall AM, Baer DM. Reducing self‐injury and corresponding self‐restraint through the strategic use of protective clothing. Journal of Applied Behavior Analysis 1984;17(4):545‐52. [MEDLINE: ] [DOI] [PMC free article] [PubMed] [Google Scholar]
Stoudemire 1996 {published data only}
- Stoudemire A, Smith DA. OBRA regulations and the use of psychotropic drugs in long term care facilities ‐ impact and implications for geropsychiatric care. General Hospital Psychiatry 1996;18(2):77‐94. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Thapa 1996 {published data only}
- Thapa PB, Brockman KG, Gideon P, Fought RL, Ray WA. Injurious falls in nonambulatory nursing home residents ‐ a comparative study of circumstances, incidence, and risk factors. Journal of the American Geriatrics Society 1996;44(3):273‐8. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Thomas 1992 {published data only}
- Thomas H Jr, Schwartz E, Petrilli R. Droperidol versus haloperidol for chemical restraint of agitated and combative patients. Annals of Emergency Medicine 1992;21(4):407‐13. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Tutunjian 1963 {published data only}
- Tutunjian K, Guido JA. A new piperidine phenothiazine (pereracetazine) in chronic psychotic patients. American Journal of Psychiatry 1963;119:776‐7. [DOI] [PubMed] [Google Scholar]
Weinrich 1995 {published data only}
- Weinrich S, Egbert C, Eleazer GP, Haddock KS. Agitation: measurement, management, and intervention research. Archives of Psychiatric Nursing 1995;9(5):251‐60. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
References to studies awaiting assessment
Bergk 2011 {published data only}
- Bergk J, Einsiedler B, Flammer E, Steinert T. A randomized controlled comparison of seclusion and mechanical restraint in inpatient settings. Psychiatric Services 2011;62(11):1310‐7. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
ISRCTN49454276 {published data only}
- Huf G, Coutinho ES, Adams CE. Physical restraints versus seclusion room for management of people with acute aggression or agitation due to psychotic illness (trec‐save): A randomized trial. Psychological Medicine 2012 Mar 12 [Epub ahead of print]. [DOI: 10.1017/S0033291712000372; MEDLINE: ] [DOI] [PubMed]
- Huf G, Coutinho ES, Ferreira MA, Ferreira S, Mello F, Adams CE. Trec‐save: A randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people: Study protocol for a randomised controlled trial. Trials 2011;12(1):180. [MEDLINE: ] [DOI] [PMC free article] [PubMed] [Google Scholar]
- Huf G, Coutinho ESF. TREC‐SAVE1.A randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people. Data on file. [DOI] [PMC free article] [PubMed]
- ISRCTN49454276. Trec‐save: A trial for aggressive or violent seriously mentally ill people. http://www.controlled‐trials.com 2011. [DOI] [PMC free article] [PubMed]
Additional references
Altman 1996
- Altman DG, Bland JM. Detecing skewness from summary information. BMJ 1996;313:1200. [MEDLINE: ; SR020600] [DOI] [PMC free article] [PubMed] [Google Scholar]
Angold 1989
- Angold A. Seclusion. British Journal of Psychiatry 1989;154:437‐44. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
APA 1985
- American Psychiatric Association. Seclusion and restraint: the psychiatric uses. Task Force Report 22. Washington, DC: American Psychiatric Association, 1985. [Google Scholar]
Aschen 1995
- Aschen SR. Restraints: does position make a difference?. Issues in Mental Health Nursing 1995;16(1):87‐92. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Brown 1992
- Brown JS, Tooke SK. On the seclusion of psychiatric patients. Social Science and Medicine 1992;35(5):711‐21. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Chow 1996
- Chow E, Desai H, Bury AS, Roy R, Bassett AS, Collins EJ. The effects of clozapine on aggression: a randomized‐controlled study. 149th Annual Meeting of the American Psychiatric Association. May 4‐9, 1996.
Crenshaw 1997
- Crenshaw WB, Cain KA, Francis PS. An updated national survey on seclusion and restraint. Psychiatric Services 1997;48(3):395‐7. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Essock 1996
- Essock SM, Hargreaves WA, Covell NH, Goethe J. Clozapine's effectiveness for patients in state hospitals: results from a randomized trial. Psychopharmacology Bulletin 1996;32(4):683‐97. [MEDLINE: ] [PubMed] [Google Scholar]
Farnham 1997
- Farnham 1997. Acute excited states and sudden death. BMJ 1997;315(7116):1107‐8. [MEDLINE: ] [DOI] [PMC free article] [PubMed] [Google Scholar]
Fisher 1994
- Fisher WA. Restraint and seclusion: a review of the literature. American Journal of Psychiatry 1994;151(11):1584‐91. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Gerlock 1983
- Gerlock A, Solomon HC. Factors associated with the seclusion of psychiatric patients. Perspectives in Psychiatric Care 1983;21(2):46‐53. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Gudeman 1981
- Gudeman JE, Dickey B, Rood L, Hellman S, Grinspoon L. Alternative to the back ward: the quarterway house. Hospital and Community Psychiatry 1981;32(5):330‐4. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Gutheil 1995
- Gutheil TG. Legal issues in psychiatry. In: Kaplan HI, Sadock BJ editor(s). Comprehensive textbook of psychiatry. Sixth. Baltimore: Williams & Wilkins, 1995:2747‐66. [Google Scholar]
Höyer 1994
- Höyer G, Drange H. Changes in the use of compulsory measures in Norwegian psychiatric institutions [Utviklingen av tvangsmidlebruk i norske psykiatriske institusjoner]. Tidsskrift for Norske Laegeforening 1994;114(5):585‐8. [MEDLINE: ] [PubMed] [Google Scholar]
Jadad 1996
- Jadad A, Moore A, Carroll D, Jenkinson C, Reynolds DJM, Gavanagh DJ, McQuay HJ. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled Clinical Trials 1996;17(1):1‐12. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Kalogjera 1989
- Kalogjera IJ, Ashok B, Watson WN, Meyer AD. Impact of therapeutic management on use of seclusion and restraint with disruptive adolescent inpatients. Hospital and Community Psychiatry 1989;40(3):280‐5. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Mason 1993
- Mason T. Seclusion theory reviewed ‐ a benevolent or malevolent intervention?. Medicine, Science and the Law 1993;33(2):95‐102. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
McDonnell 1996
- McDonnell A, Reeves S. Phasing out seclusion through staff training and support. Nursing Times 1996;32(92):43‐4. [MEDLINE: ] [PubMed] [Google Scholar]
Mulrow 1999
- Mulrow CD, Oxman AD. Cochrane Collaboration Handbook [updated March 1999]. The Cochrane Library [database on disk and CDROM]. The Cochrane Collaboration. [Google Scholar]
Owen 1998
- Owen C, Tarantello C, Jones M, Tennnant C. Violence and aggression in psychiatric units. Psychiatric Services 1998;49(11):1452‐7. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Phillips 1995
- Phillips D, Rudestam KE. Effect of nonviolent self‐defense training on male psychiatrioc staff members' aggression and fear. Psychiatric Services 1995;46(2):164‐8. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Ray 1995
- Ray NK, Rappaport ME. Use of restraint and seclusion in psychiatric settings in New York State. Psychiatric Services 1995;46:1032‐7. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Salib 1998
- Salib E, Ahmed AG, Cope M. Practise of seclusion: a five‐year retrospective review in North Cheshire. Medicine, Science and the Law 1998;38(4):321‐7. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Shah 1991
- Shah AK, Fineberg NA, James DV. Violence among psychiatric inpatients. Acta Psychiatrica Scandinavica 1991;84(4):305‐9. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Sommerness 1957
- Sommerness MD, Lucero RJ, Hamlon JS, Mahowald AM. Chlorpromazine: a controlled study with highly disturbed patients. Diseases of the Nervous System 1957;18:16‐20. [PubMed] [Google Scholar]
Swett 1994
- Swett C. Inpatient seclusion: description and causes. Bulletin of American Academy of Psychiatry and Law 1994;22:421‐30. [MEDLINE: ] [PubMed] [Google Scholar]
Tardiff 1992
- Tardiff K. The current state of psychiatry in the treatment of violent patients. Archives of General Psychiatry 1992;49(6):493‐9. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Walsh 1995
- Walsh E, Randell B. Seclusion and restraint: what do we need to know?. Journal of Child and Adolescent Psychiatric Nursing 1995;8(1):28‐40. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Way 1990
- Way BB, Banks SM. Use of seclusion and restraint in public psychiatric hospitals: patient characteristics and facility effects. Hospital and Community Psychiatry 1990;41(1):75‐81. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]
Whittington 1996
- Whittington R. An evaluation of staff training in psychological techniques for the management of patient aggression. Journal of Clinical Nursing 1996;5(4):257‐61. [MEDLINE: ] [DOI] [PubMed] [Google Scholar]