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临床试验/NCT04356963
NCT04356963已完成不适用

Adjunct Virtual Reality Pain Management in Acute Brain Injury

University of Maryland, Baltimore4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月5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
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

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

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

Nicholas Morris

Assistant Professor of Neurology

University of Maryland, Baltimore

研究点 (4)

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