Active and Passive Virtual Reality Distraction for Pain Management During Pediatric Burn Dressing Changes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Observed pain
研究概览
简要总结
This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the control. One researcher administered VR and observed pain while another researcher administered post-trial survey that measured child's perceived pain and VR experience. Nurses were asked to report the clinical utility.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Researchers and nurses did not know the group assignment until immediately prior to intervention. Following the dressing change procedure, a second researcher, blinded to the group assignment, asked participants a post-assessment that included questions about child and guardian perceived pain and subjective VR experience.
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
- •children age 6-17 years (inclusive)
- •admitted or seen in the outpatient clinic for a burn injury
- •spoke English as primary language
排除标准
- •a severe burn on the face or head that prevented the utilization of the VR
- •cognitive or motor impairment that prevented valid administration of study measures
- •visual or hearing impairments that prevented interaction with the VR environment
- •did not have a legal guardian present to give consent
结局指标
主要结局
Observed pain
时间窗: During outpatient burn dressing change, on average lasting about 15 minutes.
Researcher observed pain of patient based on the Face Legs Activity Cry and Consolability behavioral pain assessment tool (FLACC-r), using 0,1,2 numerical scale for category of face, legs, activity, cry, and consolability. Total scores range from 0-10 with higher scores indicating more pain.
Patient self-reported pain
时间窗: During outpatient burn dressing change, on average lasting about 15 minutes.
Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome.
次要结局
- Nurse reported feasibility of VR in clinical burn wound care(During outpatient burn dressing change, on average lasting about 15 minutes.)
- VR experience self-reported by patient and parents(During outpatient burn dressing change, on average lasting about 15 minutes.)
- Simulator sickness symptoms of patient(During outpatient burn dressing change, on average lasting about 15 minutes.)
研究者
Henry Xiang
Professor and Center Director
Nationwide Children's Hospital