Adjunct Virtual Reality Pain Management in Acute Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in Pain Score
研究概览
简要总结
Severe and refractory pain after acute injury is a known-risk factor for chronic opioid use disorder. In this study, the investigators will use Virtual Reality (VR) immersion as a non-pharmacological adjunct to treat pain associated with acute traumatic injuries, including traumatic brain injury. The investigators hypothesize that VR therapy will decrease pain and reduce opioid use in patients with acute traumatic injuries, including TBI.
详细描述
Each participant will undergo one VR session and two control sessions. The VR session will take place in a commercially available VR environment, the Blu, and last 20-30 minutes (VR Blu). The control sessions will include a 2D-tablet based session that mimics the VR content (Tablet Blu) and a content-less placement of the VR headset (VR Blank). The order of these sessions will be randomized across participants are intended to complete all sessions.
Each participant will complete a pre-study questionnaire to elicit their prior experience with the virtual reality as well as measures of gaming addiction/engagement, boredom, and expectancy. These scales will help us determine which patient-level factors predict response to VR. Before and after each session, participants will complete validated scales of pain, nausea, and anxiety.. Pre- and Post-VR opioid use will be recorded. Basic vital signs including heart rate, blood pressure, and respiratory rate, will be recorded before and after each session to monitor autonomic response. Advanced measures of autonomic response will include heart rate variability,,and pupillometry metrics. At the conclusion of all sessions, participants will complete another questionnaire to document their subjective experience of using VR (perceived effectiveness)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Interventions will take place in patient rooms with curtain pulled and sign to mask active intervention vs. control intervention from care providers.
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
- •Diagnosis of Traumatic Injury (including but not limited to traumatic brain injury)
- •Age greater than or equal to 18 years-old
- •Endorsing at least moderate pain as defined by documentation of at least one numeric rating pain scale score of 3 or more in the last 24 hours.
- •Glasgow Coma Scale of 15
- •Expected to stay in the hospital for at least 12 hours after enrollment
排除标准
- •Seizure prior to enrollment
- •Pregnancy
- •non-English speaking
- •Known intolerance of Virtual Reality
- •Patient unable to consent for themselves
结局指标
主要结局
Change in Pain Score
时间窗: Pre- and Post-Intervention (approximately 30 minutes)
Pre- vs. Post-Intervention Ratings on Numeric Pain Rating Scale. Numeric Pain Rating scale range is from 0 (no pain) -10 (severe pain)
次要结局
- Opioid Administration(4 hours post-intervention vs. 4 hours pre-intervention)
研究者
Nicholas Morris
Assistant Professor of Neurology
University of Maryland, Baltimore
