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临床试验/NCT04849897
NCT04849897已完成不适用

Virtual Reality Guided Imagery for Chronic Pain

University of Southern California2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年3月22日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Richeimer

Professor

University of Southern California

研究点 (2)

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