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临床试验/NCT02729259
NCT02729259已完成不适用

Water Friendly Virtual Reality for Burns

National Institute of General Medical Sciences (NIGMS)2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
"Pain and anxiety" as measured by Graphic Rating Scale

研究概览

简要总结

This study is designed to find additional methods to reduce pain during wound care. In this study the investigators use virtual reality (a form of distraction) in addition to pain medication during a burn wound care.

详细描述

This study will employ a randomized within-subjects design. There are three different conditions in this study. By randomization, the participants will experience at least two of the conditions and likely all three, depending on the number of their wound care sessions. All subjects will always receive all their usual pain medications for all treatment conditions. The three conditions are: High Tech Virtual Reality (VRD), Low Tech Virtual Reality (Nature Slides), and standard wound care (no VR). The subjects will be randomly assigned to receive some portions of their wound care sessions during High Tech Virtual Reality (VRD), some portions during Low Tech Virtual Reality (Nature Slides), and some portions with standard wound care, no virtual reality. The treatment orders will be randomized. After each treatment condition the investigators will ask subjects one pain question about their pain intensity during the most recent treatment condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Care Provider)

入排标准

年龄范围
8 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 18 years
  • Compliant and able to complete questionnaires
  • No history of psychiatric disorder
  • Not demonstrating delirium, psychosis or any form of Organic Brain Disorder
  • Able to communicate verbally
  • English-speaking

排除标准

  • Age less than 18 years
  • Not capable of indicating pain intensity
  • Not capable of filling out study measures
  • Evidence of traumatic brain injury
  • History of psychiatric disorder
  • Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems
  • Unable to communicate orally
  • Receiving prophylaxis for alcohol or drug withdrawal
  • Developmental disability
  • Any face/head/neck injuries that interfere with the use of Virtual Reality equipment
  • Non-English Speaking
  • Extreme susceptibility to motion sickness
  • Seizure history

结局指标

主要结局

"Pain and anxiety" as measured by Graphic Rating Scale

时间窗: up to an hour

Pain and anxiety is being measured

次要结局

未报告次要终点

研究者

发起方
National Institute of General Medical Sciences (NIGMS)
申办方类型
Nih
责任方
Principal Investigator
主要研究者

David R. Patterson

Professor

National Institute of General Medical Sciences (NIGMS)

研究点 (2)

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