Evaluation of Technology-Based Distractions In Pediatric Patients During Minor Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Measure anxiety score
研究概览
简要总结
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.
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
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 17 and under
- •Able to consent or have parental consent
- •Undergoing minor procedures (i.e lumbar punctures, cardiac catheterization) at Lucile Packard Children's Hospital (LPCH) or Stanford Hospital facilities
排除标准
- •People who do not consent
- •Significant Cognitive Impairment
- •History of Severe Motion Sickness
- •Current Nausea
- •Visual Problems
- •Non-English Speaking
- •Patients who clinically unstable or requires urgent/emergent intervention
- •(ASA) Physical status classification class 4 or higher
- •Patient or parental preference for General Anesthesia
结局指标
主要结局
Measure anxiety score
时间窗: Duration of procedure (usually no more than 2-4 hours)
Numerical anxiety scale (0-10), 0 being no anxiety and 10 being the worst imaginable anxiety
次要结局
- Virtual and Augmented Reality Feedback Survey(Duration of procedure (usually no more than 2-4 hours))
- Parent and Child Satisfaction Questionnaire(Duration of procedure (usually no more than 2-4 hours))
- Evaluation of Passive vs Active Interventions(Duration of procedure (usually no more than 2-4 hours))
- Asses cumulative medication dosing and the duration of procedure(Duration of procedure (usually no more than 2-4 hours))
研究者
Samuel Rodriguez
Professor
Stanford University