Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 1321 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 256547 0
Schizophrenia and related psychoses 256548 0
Personality disorders 256549 0
Bipolar affective disorder 256550 0
Anxiety disorders 256551 0
Substance use disorders 256553 0
Condition category
Condition code
Mental Health 256718 256718 0 0
Depression
Mental Health 256719 256719 0 0
Schizophrenia
Mental Health 256720 256720 0 0
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] 255823 0
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] 257607 0
Self-reported level of distress (on a scale of 1 to 10)
Timepoint [1] 257607 0
Pre and post each occasion of use of the comfort room over a 12 month duration.
Primary outcome [2] 257608 0
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] 257608 0
Pre and post each occasion of use of the comfort room over a 12 month duration.
Secondary outcome [1] 262879 0
Rates of use of seclusion (collected / measured from the seclusion register maintined on the unit).
Timepoint [1] 262879 0
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?
No
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] 256317 0
Charities/Societies/Foundations
Name [1] 256317 0
Susan Harris Fund
Country [1] 256317 0
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] 251634 0
None
Name [1] 251634 0
Address [1] 251634 0
Country [1] 251634 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258401 0
Ethics Review Committee (Royal Prince Alfred Hospital [RPAH] Zone), Sydney South West Area Health Service
Ethics committee address [1] 258401 0
Ethics committee country [1] 258401 0
Australia
Date submitted for ethics approval [1] 258401 0
Approval date [1] 258401 0
09/10/2009
Ethics approval number [1] 258401 0
X09-0261 & HREC/09/RPAH/428

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30707 0
Address 30707 0
Country 30707 0
Phone 30707 0
Fax 30707 0
Email 30707 0
Contact person for public queries
Name 13954 0
Theresa Novak
Address 13954 0
Missenden Psychiatric Unit, Building 92, Royal Prince Alfred Hospital, Missenden Road, Camperdown, NSW, 2050
Country 13954 0
Australia
Phone 13954 0
+ 61 2 9515 5878
Fax 13954 0
+ 61 2 9515 8932
Email 13954 0
[email protected]
Contact person for scientific queries
Name 4882 0
Justin Scanlan
Address 4882 0
Level 1 Administration, Concord Centre for Mental Health, CRGH, Hospital Road, Concord, NSW, 2139
Country 4882 0
Australia
Phone 4882 0
+ 61 2 9767 8985
Fax 4882 0
+61 2 9767 8901
Email 4882 0
[email protected]

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.