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临床试验/NCT05654740
NCT05654740Unknown不适用

Design of the Virtual Leisure Pilot Study - Virtual Reality Delivered Stress Reduction, Entertainment, and Distraction at a Closed Psychiatric Ward

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
124
试验地点
2
主要终点
Acceptability

研究概览

简要总结

Background: The environment at a psychiatric in-patient ward can lead to emotional distress and behavioral deviations in vulnerable individuals potentially resulting in conflicts, increased use of need-based medication and coercive actions, along with low satisfaction with treatment. To accommodate these challenges recreational and entertaining interventions are generally recommended. The tested interventions have, however, shown varying effects and often demand a high degree of planning and staff involvement while also being difficult to adapt to individual needs. Virtual Reality (VR) may help overcome these challenges.

Methods: The study is a clinical trial, employing a mixed-methods design, enrolling 124 patients hospitalized at one closed psychiatric ward in the capital region of Denmark. All patients will be offered VR based stress reduction (e.g., mindfulness/relaxation techniques), entertainment, and distraction regularly during their hospitalization. Feasibility and acceptability will be explored with qualitative interviews supplemented with repeated non-participants observations and focus groups. The effect of the intervention will be assessed by comparing quantitative outcomes (e.g., coercion, need-based medication, and perceived stress) for a 12-month period with VR experiences available to a 12-month period without VR experiences available.

Discussion: It is of significant interest to find non-intrusive interventions with minimal side-effects that may provide an alternative to pharmacological interventions and coercive actions in mental health services. If the VR intervention is found to be feasible and acceptable a larger study can be initiated and if found to be effective in a psychiatric in-patient setting, it can be scaled for use in psychiatric treatment facilities in general where it may benefit a large group of patients.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to a closed psychiatric ward
  • Ability to give informed consent

排除标准

  • Significantly impaired vision hindering engagement in Virtual Reality experiences

结局指标

主要结局

Acceptability

时间窗: up to 26 weeks

≥80% of the in-patients' consent to participating in the study

次要结局

  • Client Satisfaction(up to 26 weeks)
  • Need-based medication(up to 26 weeks)
  • Coercive actions(up to 26 weeks)

研究者

发起方
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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