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
- 2
- 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.
研究组 & 干预措施
Virtual Reality Headset Given
Virtual Reality headset (Samsung Gear VR) with mindfulness meditation app is given for patient use prior to surgery date and for duration of postoperative stay.
干预措施: Virtual Reality Headset Given (Device)
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