Condition category
Mental and Behavioural Disorders
Date applied
14/12/2010
Date assigned
04/03/2011
Last edited
28/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gisele Huf

ORCID ID

Contact details

Av Brasil 4365 Manguinhos
Rio de Janeiro
21040-900
Brazil
gisele.huf@incqs.fiocruz.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled trial comparing mechanical restraints with seclusion for aggressive mentally ill people in emergency psychiatric hospitals

Acronym

TREC-SAVE

Study hypothesis

The trial aims to test the hypothesis that one procedure (seclusion or restraints) is more effective and/or more safe for the management of agitated and violent people in emergency psychiatric hospitals.

Ethics approval

Ethics Committee from Philippe Pinel Institute in Rio de Janeiro approved on the 24th February 2010 (ref: 56/2010)

Study design

Single-centre randomised open controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Aggressive/violent mental illness

Intervention

1. Use of four point physical restraint (cotton bands) and policy of close recording of mental state, behaviour, wellbeing, in addition to standard use of medication.
2. Use of secure seclusion room and policy of close recording of mental state, behaviour, wellbeing, in addition to standard use of medication.

In the case of Instituto Philippe Pinel secure seclusion involves a locked room with minimal bedding but airy and with good day light though barred windows with no frame or glass open to the nursing station or passing patients.

The total duration of each intervention is exactly the primary outcome, but follow-up in each arm will last by two weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Time to release from restraints or seclusion

Secondary outcome measures

1. Safe resolution of episode, measured 24 hours after the beginning of the episode
2. Time in restriction, measured 24 hours after the beginning of the episode
3. Further episode, measured 24 hours after the beginning of the episode
4. Need to call the doctor on an emergency basis, measured 24 hours after the beginning of the episode
5. Refusal of oral medication, measured 24 hours after the beginning of the episode
6. Amount of medication and how administered, measured 24 hours after the beginning of the episode
7. Acceptability to patient/staff, measured 24 hours after the beginning of the episode
8. Adverse effects, measured at 2 weeks
9. Time to discharge, measured at 2 weeks

Overall trial start date

16/06/2010

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Anyone (no age or gender limits) thought to have a serious mental illness admitted to the hospital who has a degree or risk of aggression or violent behaviour that endangers themselves or others
2. Who is thought by medical and nursing staff to need some form of physical restriction
3. For whom the medical and nursing staff have doubt as to whether one form of restriction is better than the other

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

100 people

Participant exclusion criteria

1. Anyone for whom either or both packages of care are contraindicated by either medical or nursing staff
2. Anyone already randomised in this trial

Recruitment start date

16/06/2010

Recruitment end date

30/04/2011

Locations

Countries of recruitment

Brazil

Trial participating centre

Av Brasil 4365 Manguinhos
Rio de Janeiro
21040-900
Brazil

Sponsor information

Organisation

National Institute of Quality Control in Health (Brazil)

Sponsor details

Av. Brasil 4365 Manguinhos
Rio de Janeiro
21040-900
Brazil
+55(0) 21 3865 5112
gisele.huf@incqs.fiocruz.br

Sponsor type

Government

Website

http://www.incqs.fiocruz.br

Funders

Funder type

Research organisation

Funder name

National Institute of Quality Control in Health - Oswaldo Cruz Foundation (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Federal University of Rio de Janeiro (UFRJ) (Brazil) - School of medicine

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21774823

Publication citations

  1. Protocol

    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, 180, doi: 10.1186/1745-6215-12-180.

Additional files

Editorial Notes