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临床试验/NCT05512858
NCT05512858已完成不适用

Exploring the Effectiveness of a Sensory Room in Reducing Seclusion, Restraint and Aggression at an Acute Psychiatric Unit

Tel Aviv University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年8月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Number of restrictions

研究概览

简要总结

the aim of the presented study is to explore the effectiveness of a sensory room in reducing seclusion, restraint and aggression at an acute psychiatric ward.

详细描述

Background In recent years, there has been an increase in violence in mental health centers in Israel. Until recently, the phenomenon was treated under mechanical restrictions and patient isolation. Today the trend is to reduce the use of restrictions, with the main alternative being the provision of medication and de-escalation techniques, one of which is sensory stimulation using sensory rooms. A sensory room in the psychiatric unit has been found as an effective intervention for reducing patients' distress and aggression. However, the effectiveness of using the room has not yet been studied in Israel and in relation to pain.

Method

The experimental study will be conducted in two phases each lasting three months in an acute psychiatric ward:

  1. Without intervention (control group).
  2. With intervention. Data on restrictions and aggression events will be collected throughout the two phases, and the participants will undergo an evaluation process using self reports.

In addition,subjects who will participate in the intervention (study group) will wear an Empatica-E4 wristband to monitor autonomous metrics during their stay in the sensory stimulation room and will undergo a brief interview regarding their experience using the room.Thus the intervention phase (Study group) will comprise mixed methods.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Hebrew language Proficiency receiving psychiatric medication of any kind regularly for at least 14 days hospitalized in full hospitalization for up to 70 days.

排除标准

  • chronic pain, neurodevelopmental syndrome active use of psychoactive substances.

结局指标

主要结局

Number of restrictions

时间窗: through study completion, an average of 1 year

In this study, restrictions are defined as incidents of entering confinement in an isolation room and as taking additional sedative medication. The data collection for the entrance to isolation and tying rooms will be done through a tying notebook managed by the nursing staff; in the notebook, the events are recorded and signed by a doctor. Monitoring of taking the additional drug treatment will be done through the center's computerized system.

Number of aggression events

时间窗: through study completion, an average of 1 year

Aggression incidents are "exceptional incidents" in the ward, an incident in which a person or an object was harmed. These events are logged in the center's computer system.

次要结局

  • Interview - qualitative measure(after every intervention, an average of six months)
  • Emptica-E4- physiological parameter (EDM)(during the intervention, an average of six months)
  • Emptica-E4- physiological parameter (PPG)(during the intervention, an average of six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tami Bar-Shalita

Principal Investigator

Tel Aviv University

研究点 (2)

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