A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in Blood Pressure as measured by blood pressure monitor
研究概览
简要总结
Children often need procedural sedation in the emergency department during painful procedures (such as reducing fractures).
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain. VR may also reduce anxiety during sedation induction by reducing providing an alternative stimulus.
This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while undergoing procedural sedation. Investigators will measure heart rate, blood pressure, satisfaction (child, parent, provider), amount of sedatives used and compare between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Virtual Reality
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation
干预措施: Virtual Reality (Device)
Standard-of-Care
Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.
结局指标
主要结局
Change in Blood Pressure as measured by blood pressure monitor
时间窗: During the procedure at 1 minute intervals
The blood pressure monitor will display participant blood pressure. Blood pressure will be recorded at 1 minute intervals. The difference in blood pressure from recommended mean blood pressure (systolic and diastolic) based on age will be calculated and compared between groups.
Change in Heart Rate as measured by heart rate monitor
时间窗: During the procedure at 1 minute intervals
The heart rate monitor will consistently display participant heart rate. Heart rate will be recorded at 1 minute intervals. The difference in heart rate from recommended mean heart rate based on age will be calculated and compared between groups.
次要结局
- Satisfaction among Guardians by global rating scale(Immediately after the procedure)
- Time difference of the procedure(Intraoperative)
- Satisfaction among Children by global rating scale(Immediately after the procedure)
- Satisfaction among Emergency Staff by global rating scale(Immediately after the procedure)
- Emergence Phenomenon as measured by yes/no questions regarding participant experience.(Immediately after the procedure and by phone the next day)
- Type and dose of medication(Intraoperative)
- Length of stay in the Emergency Department(Intraoperative)
研究者
Ran Goldman
Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital
University of British Columbia