Virtual Reality Guided Imagery for Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of Enrolled Participants Who do Not Complete the Study as Documented in Log
研究概览
简要总结
To assess treatment with an at-home Virtual Reality Guided Imagery (VR-GI) intervention, 36 patients with chronic pain (18 with chronic back pain, CBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview.
详细描述
○ Chronic pain affects over 100 million adults in the US, resulting in disability, loss of work productivity, and overall reductions in health, making chronic pain a major public health problem with an economic burden estimated at $560-635 billion annually. Opioids, the most frequently prescribed class of drugs to control pain, lack evidence supporting their long-term efficacy and carry a 15-26% risk of misuse and abuse among pain patients, highlighting a critical need to develop effective non-pharmacological interventions for pain. Guided imagery (GI), a cognitive-behavioral technique for guiding patients to create multisensory, imagined scenes to increase well-being, is an effective non-pharmacological intervention for reducing pain. However, its effectiveness is limited by patients' imaging abilities. The long-term objective of this project is to reduce chronic pain and opioid use by developing an at-home virtual reality (VR)-GI intervention to improve chronic pain management using the Limbix VR Kit. Given the enhanced immersiveness and interactivity of VR, VR-GI is expected to reduce pain and reliance on opioids, as well as improve functional outcomes and mood, compared to traditional audio-only GI and usual care. The specific aims are to evaluate feasibility and usability of an at-home VRGI intervention in a 2-week clinical trial. Two 15-min VR-GI experiences that guide patients through psychoeducation, relaxation exercises, and interactive virtual worlds that allow them to control their experience of pain will be evaluated. To assess feasibility of an at-home VR-GI intervention, 36 patients with chronic pain (18 with chronic back pain, CBP, and 18 with complex regional pain syndrome, CRPS) will complete a 2-week intervention with at-home daily practice of VR-GI (n = 24) or audio-only GI (n = 12). Pre-post treatment measures of pain intensity, opioid use, functional outcomes, and mood will be collected. Intervention feasibility and patient satisfaction will be evaluated post-treatment via questionnaire and qualitative interview. This research directly addresses the need to improve pain treatment to prevent opioid use disorder.
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
- •Must be a patient at the University of Southern California Pain Center
- •- English Fluency
- •Diagnosis of chronic back pain or complex regional pain syndrome
- •Average pain intensity of 5 on a 0 to 10 scale for more than 3 month
- •Access to a device with video and audio capability and sufficient WiFI to participate in on-line sessions
排除标准
- •History of significant motion sickness
- •Active nausea/vomiting
- •Significant movement problems
- •Significant vision or hearing impairment
结局指标
主要结局
Number of Enrolled Participants Who do Not Complete the Study as Documented in Log
时间窗: Baseline to 2 week follow up
Participant log tracks the number of enrolled participants who discontinue intervention, are lost to follow-up and/or experience adverse events.
Number of Participants Who Are Recruited But Not Enrolled as Documented in Participant Log
时间窗: Baseline
Participant log tracks number of recruited participants who are ineligible to participate and/or decline to enroll
Opioid Medication Usage Assessed by Frequency of Use Log
时间窗: Baseline to 2 week follow up
Log with list of medications taken, dosages and frequency of use. Lower frequency indicates better outcomes.
Non-opioid Pain Medication Usage Assessed by Frequency of Use Log
时间窗: Baseline to 2 week follow up
Log with list of non-opioid pain mediction taken, dosages and frequency of use. Lower frequency of use indicates better outcomes
Number of Practice Sessions Completed by Participants as Documented in Spread Sheet
时间窗: Baseline to 2 week follow up
Spread sheet documenting proportion of at-home daily GI practice completed over 2-week intervention
Pain Assessed by Pain Numeric Rating Scale
时间窗: Baseline to 2 week follow up
Numeric Rating Scale of self-reported highest, lowest, and average pain scores (0-10) over the last 7 days. Higher scores indicate worse pain outcomes.
次要结局
- Anxiety Assessed by Generalized Anxiety Disorder Assessment: GAD-2 (GAD-7)(Baseline to 2 week follow up)
- Depression Assessed by the Patient Health Questionnaire PHQ-2(Baseline to 2 week follow up)
- Short Form Health Survey (SF12v12)(Baseline to 2 week follow up)
- Daily Pain Numerical Rating Scale(Baseline to 2 week follow up)
- Complex Regional Pain Syndrome Symptoms Assessed by the CSS 17 Patientobservation Portion(Baseline to 2 week follow up)
- Back Pain Disability Assessed by the Back Pain Oswestry Disability Index (ODI)(Baseline to 2 week follow up)
研究者
Steven Richeimer
Professor
University of Southern California
