Virtual Reality for Pain Management Study
2021年6月1日 更新者：Mark B. Powers、University of Texas at Austin
Virtual Reality (VR) is one non-pharmacological method that has shown promise as an effective means of decreasing pain levels following treatment, and for significant periods of time.
Additionally, neurobiology studies of VR have demonstrated a decrease in brain activity associated with pain.
While VR is clearly a promising, drug-free option for pain treatment, existing VR systems are expensive and use unconvincing graphics.
Recent advances in VR technology (i.e., improved realism and immersion using 360-degree 3D technology and more affordable delivery systems) allow the development of more realistic and more cost-effective applications.
Capitalizing on these advances and the investigators' experiences with VR intervention development and evaluation, the current study will test a state-of-the-art VR experience in pain management intervention (Live-Action 360° Video Virtual Reality(VVR)) and compare it to established standard computer generated imagery (CGI) 360° VVR content for pain management intervention in a medical setting.
The participant's participation will help the investigators determine which VR intervention is most effective in reducing acute pain in hospital patients.
研究概览
研究类型
介入性
注册 (实际的)
103
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。
学习地点
-
-
Texas
-
Austin、Texas、美国、78712
- University of Texas at Austin
-
-
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
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Between the ages of 18 and 65
- Reports experiencing current pain not typical of day-to-day experience during Pre-Treatment Pain Questionnaire at the onset of study visit by answering "Yes" to the first question of the questionnaire. There is no specific threshold of how much pain the participant must be in to be eligible for this study. The participant must be experiencing current pain that is not related to day-to-day, normal experiences (such as minor headaches, sprains, and toothaches).
- Scores a 15 on the Glasgow Coma Scale and a 7 or above on the abbreviated Mini Mental Status Exam.
- Patient in the acute and critical palliative care units, post surgical units, or acute care orthopedic units at University Medical Center Brackenridge in Austin, TX.
- Willing and able to provide informed consent and participate in the study visit and study follow-up questionnaire.
Exclusion Criteria:
- Hearing or visually impaired where participant cannot use the Samsung Gear VR.
- Does not report experiencing current pain during Pre-Treatment Pain Questionnaire at the onset of study visit.
- Scores below a 15 on the Glasgow Coma Scale and/or below a 7 on the abbreviated Mini Mental Status Exam
- Limited mental competency and the inability to give informed, voluntary, written consent to participate.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Live-Action 360° Video Virtual Reality
|
360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event.
Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD).
Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event.
Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video.
The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
|
|
有源比较器：CGI 360° Video Virtual Reality
|
Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display.
Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
|
|
无干预：Waitlist
Participants randomized to the waitlist group will complete all study procedures except the VR exposure.
After completion of the study visit, participants in the waitlist condition will be given the option of viewing either the Live-Action 360° 3D HD VVR or the CGI 360° 3D VVR.
|
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 |
|---|---|---|
|
Post-Treatment Pain Questionnaire
大体时间：Immediately following intervention
|
The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment.
It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad.
Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine.
Pain is current
|
Immediately following intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Follow-Up Pain Questionnaire
大体时间：Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
|
The Pain Questionnaire was used to assess the participant's pain prior to receiving VR treatment, following VR treatment, and at the ten-minute follow-up assessment.
It was derived from the Brief Pain Inventory (BPI) and contains the Numerical Rating Scales (NRS) to assess the participant's pain as outlined by recommendations for outcome measures in clinical pain trials.The NRS was also chosen because it could be administered orally if patients could not use their hands to write or use the iPad.
Scores start at 0 being no pain at all and 10 being pain as bad as you can imagine.
Pain is current
|
Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.
|
|
Presence Inventory
大体时间：Immediately following intervention
|
Self-report measure that assesses the degree of spatial presence, involvement, ecological validity, overall presence, and negative effects experienced during the VR intervention.
Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree.
Spatial presence has a total of 3 questions for a total score of 30, and higher values mean increased spatial prescence.
Ecological Validity has a total of 4 questions for a total score of 40 and higher values mean increased ecological validity.
Higher for these two subscales indicate a better outcome.
Negative Effects has a total of 4 questions for a total score of 40, and higher values mean more negative effects.
Higher scores for this subscale indicate a worse outcome.
Questions on the scale are summed.
|
Immediately following intervention
|
|
Absorption Survey
大体时间：Immediately after intervention
|
Self-report measure that assesses participant engagement with the virtual world.
Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree.
There are 12 questions with a total score of 120.
Higher scores indicate a better outcome and increased participant engagement.
|
Immediately after intervention
|
|
Present Mood Questionnaire
大体时间：Every 10 minutes for 40 minutes following intervention
|
The Present Mood Questionnaire was used to assess the participant's current mood.
The survey uses a labeled (0-10) NRS to measure the extent to which the participant feels sad, anxious, happy, and tranquil.
It was administered at each of the three assessments (baseline, post-treatment, follow-up) except for in waitlist participants, for whom it was not administered at the final assessment to reduce participant burden.
Higher values indicate worse outcomes for depression and anxiety and better outcomes for happiness and tranquility.
|
Every 10 minutes for 40 minutes following intervention
|
|
Attitudes Toward the Experience Survey
大体时间：Immediately after intervention
|
Self-report measure that assesses the participant's attitude toward the VR experience.
Questions are asked on a scale of 0-10 with 0 being strongly Disagree and 10 being strongly agree.
There are 12 questions for a total score of 120.
Higher scores mean a more positive attitude towards the experience and is a better outcome.
|
Immediately after intervention
|
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：Mark Powers, Ph.D.、University of Texas at Austin
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 (实际的)
2017年1月1日
初级完成 (实际的)
2018年7月1日
研究完成 (实际的)
2018年7月1日
研究注册日期
首次提交
2016年12月15日
首先提交符合 QC 标准的
2016年12月15日
首次发布 (估计)
2016年12月19日
研究记录更新
最后更新发布 (实际的)
2021年6月23日
上次提交的符合 QC 标准的更新
2021年6月1日
最后验证
2021年6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.