A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Change in self-reported pain
研究概览
简要总结
This study will evaluate the effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.
详细描述
In this two-group randomized clinical trial, participants will be randomly assigned to either the VR-PAT intervention group or control group (standard distraction techniques available in the home). Participants and caregivers in both groups will perform daily burn dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Participants 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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being treated for acute burn injury
- •Age 6-17 years, inclusive
- •Receiving their first outpatient clinic dressing change or being discharged from the ED or inpatient burn unit
- •Have a dressing that requires daily changes at home for at least 7 days after their first outpatient appointment or discharge from the hospital (ED or inpatient)
- •Patient and family caregivers can communicate (read and write) using English or Spanish
- •Reported at least moderate or worse NRS pain score of ≥3 (NRS 0-10 with 10 being worst pain) from the most recent dressing change.
排除标准
- •Any wounds that may interfere with study procedures
- •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, prisoners, or currently pregnant
- •Suspected child abuse
- •Families who do not have access to a VR compatible smartphone.
研究组 & 干预措施
Intervention Group
Participants will be using the VR-PAT during burn dressings.
干预措施: VR-PAT (Other)
Control Group
Participants will not be using the VR-PAT during burn dressings (other distraction methods available in the home allowed).
结局指标
主要结局
Change in self-reported pain
时间窗: Immediately following each dressing change for one week
0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain.
次要结局
- Self-reported VR experience(Immediately following each dressing change for one week)
研究者
Henry Xiang
Professor of Medicine and Center Director
Nationwide Children's Hospital