Longitudinal Virtual Reality Use in Pediatric Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Change in Children's Fear Scale
研究概览
简要总结
This study aims to investigate the use of virtual reality guided mindfulness meditation to reduce the pre and post-operative anxiety and pain of pediatric surgical patients.
详细描述
Pre-procedural anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. Post-procedural pain has been shown to negatively impact future interactions with healthcare personnel. The purpose of this study is to determine the feasibility of using guided mindfulness meditation through a non-invasive device (virtual reality headset) to manage pre-procedure anxiety and post-procedure anxiety and pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have parental consent if under 18 or 18 and older but unable to provide own consent
- •Can comprehend instructions in English language
- •Is undergoing surgical procedure requiring general anesthesia at Lucile Packard Children's Hospital
- •Children that are normally healthy (ASA I) or have a mild systemic disease (ASA II, III)
排除标准
- •Children with significant cognitive impairment or developmental delays per parental report or H&P
- •Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive >24hours or without operation)
- •Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
- •Children with history of seizures related to photosensitivity.
结局指标
主要结局
Change in Children's Fear Scale
时间窗: Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis)
The Children's Fear Scale (McMurty et al., 2011) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-4 scale how scared a child is at the given moment.
Change in Faces Pain Scale
时间窗: Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis)
The Faces Pain Scale (Hicks et al., 2001) is a self-report scale that uses cartoon depictions of faces to quantify on a 0-10 scale how much pain a child is experiencing at the given moment.
Change in Anxiety Scale
时间窗: Before and after every use of the app (from date of enrollment to surgical procedure, up to 8 weeks. If patient has not undergone surgical procedure by 8 weeks, participation in study will be concluded and subject censored during data analysis)
A self-report question on a 1-5 scale will be asked to assess how much anxiety a child is experiencing at the given moment.
次要结局
- Clinician Satisfaction Surveys(Satisfaction survey will be administered to physicians within 48 hours of procedure completion. Physicians may return surveys up to one month post-procedure.)
- Patient and Parent Satisfaction Surveys(Satisfaction surveys will be administered at the time of study completion (when the patient has completed his/her surgical procedure and is ready for hospital discharge/or 30 days post-procedure, whichever occurs first))
研究者
Stephanie D. Chao
Assistant Professor of Surgery (Pediatric Surgery)
Stanford University