Comparative Effects Of Virtual Reality Vs Sham VR On Fibromyalgia Impact: A Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Score After Sham vs. Active VR
研究概览
简要总结
The purpose of this study is to understand the therapeutic impact of VR on Fibromyalgia symptoms and potentially increase the scope of treatment options for patients suffering from Fibromyalgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to the intervention type. They will not be informed whether they are receiving the active intervention (TRIPP VR meditation) or the sham VR. Study staff administering the interventions will not be blinded due to the nature of the VR content and setup requirements.
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
- •Adults aged >18 years old
- •Diagnosis of fibromyalgia based on ACR 2016 criteria
- •Stable on current medications and non-pharmacologic treatments for 4 weeks
- •Ability and willingness to use a Meta Quest 3 VR headset Fluent in English
- •Provide informed consent
排除标准
- •History of seizures or conditions contraindicating VR use
- •Severe psychiatric illness (e.g., psychosis)
- •Cognitive impairment interfering with study participation
- •Participation in other interventional trials
研究组 & 干预措施
Sequence A (TRIPP VR to Sham VR)
Participants in this arm will receive 2 weeks of TRIPP VR meditation followed by a 2-week washout period, then 2 weeks of sham VR.
干预措施: TRIPP VR Meditation (Device)
Sequence B (Sham VR to TRIPP VR)
Participants in this arm will receive 2 weeks of sham VR followed by a 2-week washout period, then 2 weeks of TRIPP VR meditation.
干预措施: Sham VR (Behavioral)
结局指标
主要结局
Change in Fibromyalgia Impact Questionnaire Revised (FIQR) Score After Sham vs. Active VR
时间窗: Baseline, Week 2, and Week 4
The primary outcome is the change in Fibromyalgia Impact Questionnaire Revised (FIQR) score from baseline to post-intervention, comparing scores after sham VR and after active TRIPP VR meditation. FIQR ranges from 0-100 and higher scores indicate higher impact of the condition, ie are worse. FIQR will be measured at baseline, week 2, and week 4. For Sequence A, the sham VR score is taken at week 4; for Sequence B, at week 2. For Sequence A, the active VR score is at week 2; for Sequence B, at week 4. The primary comparison will be the within-subject difference in FIQR change from baseline between sham and active VR periods.
次要结局
未报告次要终点
研究者
Anushka Irani
Principal Investigator
Mayo Clinic