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TREC-SAVE 试验:一项比较机械约束与隔离用于治疗有攻击或暴力行为的严重精神疾病患者的随机试验:一项随机对照试验的研究方案。

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.

机构信息

National Institute of Quality Control in Health-Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.

出版信息

Trials. 2011 Jul 20;12:180. doi: 10.1186/1745-6215-12-180.

DOI:10.1186/1745-6215-12-180
PMID:21774823
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3154155/
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.

摘要

背景

每天都有成千上万被认为患有严重精神疾病的人被隔离或约束。如果没有公平的测试,这些技术将继续在严格的证据基础之外使用。由于这种强制性治疗,所有相关人员都容易受到虐待和批评。本文介绍了一项随机试验的方案,比较了严重精神疾病患者的隔离与约束。

方法/设计:地点-巴西里约热内卢一家大型精神病院的普通精神病病房。参与者-任何被认为具有攻击性或暴力倾向的人,或被护理和医务人员怀疑或已知患有严重精神疾病的人,他们需要限制,但他们也不确定是应该隔离还是约束。干预措施-标准护理是在床边用强棉布绑扎,并根据需要给予药物治疗和密切观察,或者是另一种标准护理,使用一个最小配备的隔离室,但窗户是敞开的,但有栅栏通向护士站。结果-限制解除的时间、早期治疗改变、额外发作、不良影响/事件、发作期间的护理满意度。持续时间-2 周。标识符:ISRCTN49454276 http://www.controlled-trials.com/ISRCTN49454276。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d374/3154155/348f03ebafad/1745-6215-12-180-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d374/3154155/98306eae6526/1745-6215-12-180-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d374/3154155/348f03ebafad/1745-6215-12-180-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d374/3154155/98306eae6526/1745-6215-12-180-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d374/3154155/348f03ebafad/1745-6215-12-180-2.jpg

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