Evaluation of the Effectiveness of a Comfort-sensory Room in the Control of Agitation in a Functional Mental Health Rehabilitation Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Number of mechanical restraints
研究概览
简要总结
In the initial approach of the study, it was considered that the comfort room would be used by all patients with GCT treated in the Functional Rehabilitation Area 1 (ARF 1) of the Álava Psychiatric Hospital. However, with the onset of the covid-19 pandemic, the service itself decided to separate the patients into two units, in order to reduce positive contacts. Consequently, the use of the comfort room will only be available for one of the two units, which will be considered as the intervention group, while the other unit will be considered as the control group. It is also important to note that the patients in the intervention group unit have a more severe mental state than those in the control group. The control group are older and more psychopathologically stable patients. So already from the initial moment of the study they are two populations with different characteristics.
Main Objective:
To determine the effectiveness of the use of a sensory comfort room in the functional rehabilitation area 1 of the HPA. It would be considered effective if mechanical restraints decrease by 5% in the intervention group with respect to the previous year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to functional rehabilitation area 1 presenting with questionable, mild or moderate Agitation (score less than or equal to 20 on the PEC scale) or at the patient's request.
- •To have freely accepted to participate in the intervention and to have signed the informed consent. An information sheet will also be given to the patient and an information sheet to the tutor (APPENDIXES 1 and 2). Experts in easy reading are consulted to adapt this document.
排除标准
- •Severe and extremely severe agitation (score greater than or equal to 21 on the PEC scale). Immediate previous physical aggression.
- •Declination of the signature of informed consent.
- •Any participant who does not comply with the rules of use of the room will be excluded from the study.
结局指标
主要结局
Number of mechanical restraints
时间窗: Up to 24 months
Mechanical restraint is understood as the extreme therapeutic intervention, through the application of immobilizing restrictive devices to limit a patient's freedom and, in turn, allows us to ensure their own safety and/or that of other
次要结局
- Number of isolations(Up to 24 months)
- Change in the agitation level(Through study completion, an average of 2 years)
- Number of patients who need Rescue medication(Up to 24 months)
研究者
Maria Olárizu Olalde Ortiz
Nurse in Araba University Hospital
Bioaraba Health Research Institute