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临床试验/NCT07119736
NCT07119736已完成不适用

The Effects of Relaxation Using Virtual Reality in Forensic Psychiatric Patients. A Randomized Cross-over Clinical Trial

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Difference in VAS Score for relaxation

研究概览

简要总结

During this clinical Cross-over study, the investigators want to investigate whether the use of Virtual Reality (VR) is a valuable application to achieve relaxation in forensic psychiatric patients.

This study investigates the short- and medium-term effect of VRelax on both acute and chronic stress and compares it with a standard relaxation exercise of choice (TAU).

详细描述

During this clinical Cross-over study, it will be investigated whether the use of Virtual Reality (VR) is a valuable application to achieve relaxation in forensic psychiatric patients within the PC Sint-Jan Baptist, Zelzate, Belgium. Due to the fact that very realistic situations can be created in VR environments that forensic psychiatric patients normally cannot experience due to their limited freedom, it seems to be an extra important asset for them that meets the limitations of confinement and freedom-restricting measures. In addition, the highly immersive character of the application supports patients who are unable to perform a standard relaxation exercise through their own imagination or empathy.

This study investigates the short- and medium-term effect of VRelax on both acute and chronic stress and compares it with a standard relaxation exercise of choice (TAU).

The relaxation software that that will be used in the study is VRelax (www.vrelax.com), which is available in Dutch (and English) for which the results of a first crossover randomized controlled trial was recently published.

The research design is a crossover randomized controlled trial with two parts: a standard relaxation of choice and a VR relaxation using the VRelax software. The VRelax app contains 360˚ VR videos of relaxing natural environments. The variety of landscapes includes beaches, mountains, proximity to animals, etc. Interactive elements are embedded in the videos, for example a game of popping air bubbles underwater, shooting stars in a night sky and audio tracks of relaxation exercises.

The study population consists of forensic psychiatric patients (depressive disorder, bipolar disorder, anxiety disorder or psychotic disorder, borderline, antisocial disorder,... (DSM-5 diagnosis)) who reside in the Sint-Jan Baptist psychiatric hospital in Zelzate, Belgium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

盲法说明

participant data will be pseudonymized

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Be admitted for at least 4 months as a forensic psychiatric patient within medium or high security, at Sint-Jan Baptist in Zelzate.

排除标准

  • •Acute psychosis, acute mania, epilepsy, pacemaker, balance disorders, individuals in the acute withdrawal phase of substance or alcohol abuse, severe cardiac abnormalities, serious eye disorders, pregnancy.

研究组 & 干预措施

Relaxation sessions groep 1

Experimental

there will be 10 sessions of VR and 10 sessions of standard relaxation

干预措施: Standard relaxation (Other)

Relaxation sessions groep 1

Experimental

there will be 10 sessions of VR and 10 sessions of standard relaxation

干预措施: VR relaxation (Device)

Relaxation sessions groep 2

Experimental

there will be 10 sessions of standard relaxation and 10 sessions of VR

干预措施: VR relaxation (Device)

Relaxation sessions groep 2

Experimental

there will be 10 sessions of standard relaxation and 10 sessions of VR

干预措施: Standard relaxation (Other)

结局指标

主要结局

Difference in VAS Score for relaxation

时间窗: 20 minutes

on a scale of 1-10 How relaxed are you feeling at this moment?

次要结局

  • Difference in VAS Score for cheerfullness(20minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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