Functional Response to Immersive Virtual Reality in Pediatric Patients Post-Laparoscopic Appedectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Effect of VR-biofeedback on pain
研究概览
简要总结
To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.
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
- •Age 8 - 18 years
- •Able to read, understand, and speak English
- •Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix
排除标准
- •Outside of 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 disorders
- •Conditions that would preclude the application of the VR headset, such as craniofacial deformities
- •History of chronic pain, frequent opioid use and/or active cancer therapy
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 VR-biofeedback on medication use
时间窗: 24-90 hours
Amount of pain medications used will be collected
Effect of VR-distraction on medication use
时间窗: 24-90 hours
Pain medications used will be collected
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.
Effect on VR-biofeedback on anxiety
时间窗: 30 minutes after VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
Effect of VR-distraction on anxiety
时间窗: 30 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety.
次要结局
- Role of pain catastrophizing(One time prior to study visit)
- Role of anxiety on changes in pain(One time prior to study visit)