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