Virtual Reality (VR) Audiovisual Distraction to Reduce Pain and Anxiety for Prone Pain Procedures
2026年8月18日 更新者：Michael Jihnouk Jung、University of California, Davis
This study evaluates whether virtual reality (VR) audiovisual distraction can reduce pain, anxiety, and the need for pain and anxiety medications during prone pain procedures, compared to standard care alone.
The trial design is a two-arm, parallel assignment, randomized controlled trial at a single site, the UC Davis Pain Medicine Clinic.
Patients will be randomized in a 1:1 allocation to the intervention (commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support) vs control (standard medical care).
The primary outcome will be a composite outcome analyzed using the Win Ratio method comparing opioid/sedative medication use, intra-procedural pain scores, and intra-procedural anxiety scores between groups.
Approximately 230 people at UC Davis are expected to participate (Up to 20 patients for the preliminary run-in period to acclimatize research and clinical staff and 210 total for the randomized clinical trial).
Each participant's involvement consists of one visit, estimated at 30 minutes.
研究概览
研究类型
介入性
注册 (估计的)
230
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Michael J. Jung, MD, MBA
- 电话号码：916-734-6824
- 邮箱：mijjung@health.ucdavis.edu
学习地点
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California
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Sacramento、California、美国、95817
- UC Davis Pain Clinic
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接触：
- Michael J. Jung, MD, MBA
- 电话号码：916-734-6824
- 邮箱：mijjung@health.ucdavis.edu
-
首席研究员：
- Michael J. Jung, MD, MBA
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients aged 18 years old or older
- Male and female gender
- Referred to UC Davis Pain Medicine Clinic and require a prone pain procedure
- English speaking and with the ability to understand oral and written instructions
Exclusion Criteria:
- Pregnant women
- Prisoners
- Patients who have high risk of motion sickness
- Seizure disorder
- Visual/hearing impairment
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Virtual Reality (VR) Audiovisual Distraction
Participants received a commercially available virtual reality headset (Meta Quest 3) with audiovisual calming nature scene and an ergonomic cushion/support in addition to standard medical care based on the independent treating physician.
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Using a VR headset with an ergonomic cushion/support which will display a calming audiovisual experience during the procedure.
The VR headset is a commercially available Meta Quest 3.
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无干预：Standard Care
Standard medical care based on the independent treating physician, which includes standard care such as numbing and sedating medicines without audiovisual distraction.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Composite Outcome Using Win Ratio Method (Opioid/Sedative Use, Intra-procedural Pain Score, and Intra-procedural Anxiety Score)
大体时间：During the procedure, approximately 30 minutes
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The primary outcome is a composite analyzed using the Win Ratio method.
Each intervention patient will be compared with each control patient.
Pairs are evaluated in priority order: opioid/sedative use, intra-procedural pain score, then intra-procedural anxiety score.
A patient who received no opioids/sedatives wins over one who did; if tied, the lower pain score wins; if still tied, the lower anxiety score wins.
If all three measures are identical, the pair is a tie.
The Win Ratio is calculated as total intervention wins divided by total control wins.
A Win Ratio >1 indicates superiority of VR; a 95% confidence interval will be calculated.
Pain and anxiety are measured using the Numeric Rating Scale (NRS), from 0 (none) to 10 (worst possible), with higher scores indicating worse outcomes.
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During the procedure, approximately 30 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Opioid and Sedative Medication Use
大体时间：During the procedure, approximately 30 minutes
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Whether opioid and/or sedative medications were administered during the prone pain procedure.
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During the procedure, approximately 30 minutes
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Intra-procedural Pain Score on the Numeric Rating Scale (NRS)
大体时间：During the procedure, approximately 30 minutes
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Pain assessed using the Numeric Rating Scale (NRS).
Scores range from 0 (no pain) to 10 (worst possible pain).
Higher scores indicate a worse outcome.
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During the procedure, approximately 30 minutes
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Intra-procedural Anxiety Score on the Numeric Rating Scale (NRS)
大体时间：During the procedure, approximately 30 minutes
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Anxiety assessed using the Numeric Rating Scale (NRS).
Scores range from 0 (no anxiety) to 10 (worst possible anxiety).
Higher scores indicate a worse outcome.
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During the procedure, approximately 30 minutes
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Pain Intensity on the Patient-Reported Outcomes Measurement Information System Pain Intensity Short Form-3a (PROMIS Pain Intensity SF-3a)
大体时间：Pre-procedure and post-procedure, approximately 30 minutes
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PROMIS Pain Intensity Short Form-3a.
Scores range from 3 to 15.
Higher scores indicate a worse outcome.
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Pre-procedure and post-procedure, approximately 30 minutes
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Anxiety on the State-Trait Anxiety Inventory 6-item (STAI-6)
大体时间：Pre-procedure and post-procedure, approximately 30 minutes
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State-Trait Anxiety Inventory 6-item (STAI-6).
Scores range from 4 to 24.
Higher scores indicate a worse outcome.
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Pre-procedure and post-procedure, approximately 30 minutes
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Patient Global Impression of Change (PGIC)
大体时间：Post-procedure, approximately 30 minutes
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Patient Global Impression of Change.
Scores range from 1 to 7. Higher scores indicate a better outcome.
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Post-procedure, approximately 30 minutes
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Patient Experience Satisfaction
大体时间：Post-procedure, approximately 30 minutes
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Patient Experience Satisfaction.
Scores range from 0 to 10. Higher scores indicate a better outcome.
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Post-procedure, approximately 30 minutes
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Virtual Reality Experience Feedback
大体时间：Post-procedure, approximately 30 minutes
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Virtual Reality experience feedback (immersion, comfort, side effects, usability, task load).
No score range or directionality as it is a free response section.
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Post-procedure, approximately 30 minutes
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Michael J. Jung, MD, MBA、University of California, Davis
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年8月18日
首先提交符合 QC 标准的
2026年8月18日
首次发布 (实际的)
2026年8月21日
研究记录更新
最后更新发布 (实际的)
2026年8月21日
上次提交的符合 QC 标准的更新
2026年8月18日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.