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Published in: Trials 1/2011

Open Access 01-12-2011 | Study protocol

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

Authors: Gisele Huf, Evandro SF Coutinho, Marco AV Ferreira, Silvana Ferreira, Flavia Mello, Clive E Adams, TREC-SAVE Collaborative group

Published in: Trials | Issue 1/2011

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Abstract

Background

Thousands of people whose aggression is thought due to serious mental illness are secluded or restrained every day. Without fair testing these techniques will continue to be used outside of a rigorous evidence base. With such coercive treatment this leaves all concerned vulnerable to abuse and criticism. This paper presents the protocol for a randomised trial comparing seclusion with restraints for people with serious mental illnesses.

Methods/Design

Setting-General psychiatric wards of a large psychiatric hospital in Rio de Janeiro, Brazil. Participants-Anyone aggressive or violent suspected or known to have serious mental illness for whom restriction is felt to be indicated by nursing and medical staff, but also for whom they are unsure whether seclusion or restraint would be indicated. Interventions-The standard care of either strong cotton banding to edge of bed with medications as indicated and close observation or the other standard care of use of a minimally furnished seclusion room but with open but barred windows onto the nursing station. Outcomes-time to restrictions lifted, early change of treatment, additional episodes, adverse effects/events, satisfaction with care during episode. Duration-2 weeks. Identifier: ISRCTN 49454276 http://​www.​controlled-trials.​com/​ISRCTN49454276
Appendix
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Metadata
Title
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
Authors
Gisele Huf
Evandro SF Coutinho
Marco AV Ferreira
Silvana Ferreira
Flavia Mello
Clive E Adams
TREC-SAVE Collaborative group
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Trials / Issue 1/2011
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-12-180

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