Virtual Reality for Pain Management Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Post-Treatment Pain Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Post-Treatment Pain Questionnaire
时间窗: 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
次要结局
- Presence Inventory(Immediately following intervention)
- Follow-Up Pain Questionnaire(Every 10 minutes for 40 minutes following intervention and 1 week following intervention. Meaned.)
- Present Mood Questionnaire(Every 10 minutes for 40 minutes following intervention)
- Attitudes Toward the Experience Survey(Immediately after intervention)
- Absorption Survey(Immediately after intervention)
研究者
Mark B. Powers
Research Associate Professor
University of Texas at Austin