Cluster-randomized Controlled Trial of Virtual Reality for Patients With Chronic Musculoskeletal Pain (Wait & Work)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 8
- 主要终点
- Change in quality of life measured using the short-form 12 (SF-12)
研究概览
简要总结
This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •aged 18 years or older
- •suffering from primary or secondary CMP
- •finished with biomedical diagnostics and treatment
- •open to biopsychosocial treatment
- •willing and capable of complying with study procedures.
排除标准
- •not able to finish the VR intervention due to physical (e.g. visual impairment), mental (e.g. severe sensitivity to stimuli) or practical problems (e.g. insufficient tech-literacy)
- •unable to finish Dutch questionnaires.
结局指标
主要结局
Change in quality of life measured using the short-form 12 (SF-12)
时间窗: Baseline, directly after the intervention, and at six months follow-up
This questionnaire on quality of life scores from 12 (worst possible score) to 56 (best possible score)
次要结局
- Change in pain intensity measured using the numeric pain rating scale (NPRS)(Baseline, directly after the intervention, and at six months follow-up)
- Change in pain catastrophizing measured using the pain catastrophizing scale (PCS)(Baseline, directly after the intervention, and at six months follow-up)
- Change in pain self-efficacy measured using the pain self-efficacy questionnaire (PSEQ)(Baseline, directly after the intervention, and at six months follow-up)
- Change in quality of care measured using the client satisfaction questionnaire (CSQ-8)(Baseline, directly after the intervention, and at six months follow-up)
- Change in pain acceptance measured using the chronic pain acceptance questionnaire (CPAQ-8)(Baseline, directly after the intervention, and at six months follow-up)
- Change in medication use measured using an open-ended question(Baseline, directly after the intervention, and at six months follow-up)
- Change in feelings of anxiety and depression measured using the hospital anxiety and depression scale (HADS)(Baseline, directly after the intervention, and at six months follow-up)
研究者
Monique Tabak
Professor
University of Twente