Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Self-reported VR experience.
研究概览
简要总结
This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT will report less pain during their dressing changes.
详细描述
Subjects will be randomly assigned to either the VR-PAT intervention group or Control group. Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Subjects and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.
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
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients age 5-17 years (inclusive)
- •receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution
- •have a dressing that requires daily changes at home for at least one week
- •can communicate orally
排除标准
- •any wounds that may interfere with study procedures (i.e. face)
- •vision, hearing, or cognitive/motor impairments preventing valid administration of study measures
- •history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras
- •minors in foster care
- •suspected child abuse
- •unable to communicate in English
- •families who do not have access to a smartphone (due to the VR-PAT game requirements)
结局指标
主要结局
Self-reported VR experience.
时间窗: Daily for 15-30 minutes burn dressing change for up to 7 days.
1-10 rating scale of degree of realism, pleasure, and satisfaction with VR (VR-PAT arm only), with higher score meaning better outcome.
Pain assessment during dressing changes.
时间窗: 15-30 minutes during daily burn dressing changes for up to 7 days.
1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome.
Observed VR experience.
时间窗: Daily for 15-30 minutes burn dressing change for up to 7 days.
caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire.
次要结局
- Burn-related medications(Daily for burn dressing change for up to 7 days.)
研究者
Henry Xiang
Professor and Center Director
Nationwide Children's Hospital