Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients: a Randomized Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Effect of VR-biofeedback on pain
研究概览
简要总结
Determine the impact of VR-Biofeedback, VR-distraction, and 360 video on pain and medication utilization in patients undergoing surgery; determine the role of anxiety and pain catastrophizing on changes in pain following VR-BF in patients undergoing surgery.
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
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 8 - 18 years
- •Able to read, understand and speak English
- •Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service
排除标准
- •Outside the age range (< 8 or > 18 years)
- •History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
- •History of vertigo, dizziness, and/or seizure disorder
- •Conditions that would preclude the application of the VR headset, such as surgeries of the head and neck
研究组 & 干预措施
VR-Biofeedback
干预措施: VR-Biofeedback (Other)
VR-Distraction
干预措施: VR-Distraction (Other)
360 Video
干预措施: 360 Video (Other)
结局指标
主要结局
Effect of VR-biofeedback on pain
时间窗: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Effect of 360 video on pain
时间窗: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
Effect of VR-distraction on pain
时间窗: Postoperatively 24 - 90 hours.
Pain scores will be collected. Pain will be rated using the numerical rating scale. Participant will rate their pain from 0 - 10. 0 meaning no pain and 10 being the worst pain imaginable.
次要结局
- Effect of 360 video on anxiety(After 10 minute VR session.)
- Effect of 360 video on medication use(Duration of hospital stay up to 30 days after discharge)
- Role of anxiety on changes in pain(One time prior to study visit)
- Role of pain catastrophizing(One time prior to study visit)
- Effect of VR-biofeedback on anxiety(After 10 minute VR session. Anxiety will be rated using a visual analog scale.)
- Effect of VR-distraction on medication use(Duration of hospital stay up to 30 days after discharge)
- Effect of VR-distraction on anxiety(After 10 minute VR session.)
- Effect of VR-biofeedback on medication use(Duration of hospital stay up to 30 days after discharge)
- Effect of VR-biofeedback on anxiety(Before 10 minute VR session.)
- Effect of VR-distraction on anxiety(Before 10 minute VR session.)
- Effect of 360 video on anxiety(Before 10 minute VR session.)