ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000082000

Ethics application status

Approved

Date submitted

15/01/2010

Date registered

22/01/2010

Date last updated

11/07/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effects of implementing a comfort room in an acute mental health unit on seclusion rates and client’s level of distress.

Scientific title

Does the use of a comfort room reduce distress and reduce the use of seclusion for patients in an acute mental health inpatient unit, compared with no comfort room.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Schizophrenia and related psychoses

Personality disorders

Bipolar affective disorder

Anxiety disorders

Substance use disorders

Condition category

Condition code

Mental Health

Depression

Mental Health

Schizophrenia

Mental Health

Psychosis and personality disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The introduction and use of a "comfort room" in an acute inpatient mental health unit. Comfort rooms are specialised rooms, which have a range of comforting materials and resources in them to assist an individual who is distressed to relax and perform “self-soothing” routines (e.g., relaxation exercises, self-massage, use of weighted blankets / comfort wraps). Inpatients will have access to the room (24 hours per day) to allow them to soothe themselves at times of distress to reduce the need for other, more invasive procedures such as intramuscular medication and/or seclusion. Duration of intervention will be 12 months.

Intervention code [1]

Other interventions

Comparator / control treatment

Previous rates of seclusion prior to the introduction of the comfort room (from the 12 months prior to the introduction of the room: that is, October 2008 to September 2009).

Control group

Historical

Outcomes

Primary outcome [1]

Self-reported level of distress (on a scale of 1 to 10)

Timepoint [1]

Pre and post each occasion of use of the comfort room over a 12 month duration.

Primary outcome [2]

Observations of intensity of behaviour by staff (rated on a scale of 1 to 10; e.g., level of distress, anger, anxiety, irritibility, paranoia)

Timepoint [2]

Pre and post each occasion of use of the comfort room over a 12 month duration.

Secondary outcome [1]

Rates of use of seclusion (collected / measured from the seclusion register maintined on the unit).

Timepoint [1]

12 months prior to the introduction of the comfort room compared with the 12 months following introduction (a 6-month review will also occur).

Eligibility

Key inclusion criteria

Current inpatient of the acute mental health unit. Patients self-select to use the comfort room or are encouraged to use the room by staff members.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

No specific exclusion criteria.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients self-select to use the comfort room or are encouraged to use the room by staff members.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

20/10/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Susan Harris Fund

Address [1]

Financial Services, Concord Repatriation General Hospital, Hospital Road, Concord, NSW, 2139

Country [1]

Australia

Primary sponsor type

Hospital

Name

Area Mental Health Services, Sydney South West Area Health Service

Address

c/- Area Mental Health Services, Concord Repatriation General Hospital, Hospital Road, Concord, NSW, 2139

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Review Committee (Royal Prince Alfred Hospital [RPAH] Zone), Sydney South West Area Health Service

Ethics committee address [1]

Research Development Office, Level 3, Building 92, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW, 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/10/2009

Ethics approval number [1]

X09-0261 & HREC/09/RPAH/428

Summary

Brief summary

Comfort rooms are specialised rooms, often within an inpatient psychiatric unit, which have a range of comforting materials and resources in them to assist an individual who is distressed to relax and perform “self-soothing” routines (e.g., relaxation exercises, self-massage, use of weighted blankets / comfort wraps) Previous investigations have demonstrated the utility of comfort rooms in reducing levels of distress in clients and also in reducing the use of seclusion and restraint.

The aim of this project is to evaluate the effectiveness of the introduction of a comfort room into and acute inpatient mental health unit.  Outcomes will be measured by a number of indicators: (1) rate of utilisation of the comfort room; (2) average length of time individuals remain in the comfort room; (3) behaviours observed before and after use of the comfort room; (4) what resources were used by the individual whilst in the comfort room; and (5) rates of seclusion before and after the introduction of the comfort room. Additionally, clients will be asked to report their subjective level of distress before and after using the room.  This will be done by way of two simple questions asked by a member of nursing staff following the client leaving the comfort room: “Before you went into the comfort room, how distressed were you feeling on a scale of 1 to 10” and “Now, how distressed are you feeling, on a scale of 1 to 10”.  Asking clients to rate their level of distress prior to using the comfort room is considered inappropriate, as any such delay in accessing the comfort room is not in keeping with the philosophy of quick and early access to the comfort room to promote best self-management of distress.

It is hypothesised that the introduction of the comfort room will reduce distress experienced by clients by providing a comfortable environment and resources to self-sooth and de-stress. This hypothesis will be tested in the following ways:
(1) Does the use of the comfort room reduce the level of self-reported distress experienced by clients?
(2) Are fewer disruptive / disturbed behaviours noted in clients following the use of the comfort room?
(3) Do rates of seclusion reduce following the introduction of the comfort room?

The potential significance of this study is large. Similar projects are readily implementable (with limited capital outlay) in a range of settings across Australia and the results of this study have the potential to inform and change clinical practice in inpatient psychiatric units, leading to better outcomes for a large number of individuals across Australia. The results of this study will also add to the developing knowledge base around interventions designed to reduce the use of seclusion in Australian psychiatric inpatient units.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Theresa Novak

Address

Missenden Psychiatric Unit, Building 92, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW, 2050

Country

Australia

Phone

+ 61 2 9515 5878

Fax

+ 61 2 9515 8932

theresa.novak@email.cs.nsw.gov.au

Contact person for scientific queries

Name

Justin Scanlan

Address

Level 1 Administration, Concord Centre for Mental Health, CRGH, Hospital Road, Concord, NSW, 2139

Country

Australia

Phone

+ 61 2 9767 8985

Fax

+61 2 9767 8901

justin.scanlan@email.cs.nsw.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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Documents added manually

Documents added automatically