Virtual Reality Analgesia for Pediatric Burn Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- "Worst Pain" rating of pain intensity during Music vs. during VR
研究概览
简要总结
Many children with large severe burns report severe pain during burn wound cleaning. The current study explores whether adjunctive immersive Virtual Reality distraction may help reduce the intensity of pain experienced by children during burn wound cleaning by taking the patient's mind off their pain.
详细描述
All patients always receive their usual pain medications. Using a within-subjects, within-wound care design, in the current study, pediatric patients being treated for severe burn injuries will receive music distraction during some portions of their wound care (active comparator condition), and they will receive what we predict will be an unusually strong distraction, immersive virtual reality (the experimental treatment) during other comparable portions of the same wound cleaning sessions. During virtual reality, each patient will look into virtual reality goggles, and will play a simple cartoon-like virtual reality game SnowWorld during burn wound cleaning. After each wound care session, the patient will rate how much pain they experienced during wound care during No VR (music only) compared to how much pain they experienced during wound care during virtual reality, on each study day, for up to 10 study days per patient. Treatment order randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blinding can be challenging in behavioral studies. To help control for demand characteristics, the current study uses an active comparator "music distraction" vs. the experimental treatment condition "immersive virtual reality".
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
music distraction (No VR condition)
In addition to their standard pain medications, patients will listen to music during comparable portions of their burn wound cleaning procedure, on each study day.
干预措施: music distraction (No VR) (Behavioral)
virtual reality distraction (Yes VR)
In addition to their standard pain medications, patients will play a virtual realty game named SnowWorld during some portions of their burn wound cleaning procedure, on each study day.
干预措施: virtual reality distraction (Yes VR) (Behavioral)
结局指标
主要结局
"Worst Pain" rating of pain intensity during Music vs. during VR
时间窗: measured after burn wound care on each study day for up to 10 study days per patient
worst pain during wound care. This single question measures the sensory component of pain during wound care. Patients will rate their "worst pain" during burn wound care. on a zero to ten scale, where zero is "no pain at all " and 10 is "excruciating pain". Lower scores represent better outcome. No subscales.
次要结局
- Graphic Rating Scale "Time spent thinking about pain" during Music vs. during VR(measured after burn wound care on each study day for up to 10 study days per patient)
- Graphic Rating Scale "Fun" during Music vs. during VR(measured after wound care on each study day for up to 10 study days per patient)
- Child Health Questionnaire(measured at 0, 9 months and 12 month followup visits)
- Graphic Rating Scale Satisfaction with pain management during Music vs. during VR(Measured after wound care on Study Day 1.)
- Graphic Ratings Scale measure of pain unpleasantness during Music vs. during VR(measured after woundcare on each study day for up to 10 study days per patient)