Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
追踪信息 | |||
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首次提交日期 ICMJE | September 20, 2018 | ||
首次发布日期e ICMJE | October 2, 2018 | ||
最后更新发布日期 | October 2, 2018 | ||
预计研究开始日期 ICMJE | September 21, 2018 | ||
预计主要完成日期 | September 21, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Change in Heart Rate as measured by heart rate monitor[ Time Frame: 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. Change in Blood Pressure as measured by blood pressure monitor[ Time Frame: 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. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department | ||
正式标题 ICMJE | A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department | ||
简要概况 | 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. |
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详细说明 | |||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Supportive Care |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Recruiting | ||
预计入组 ICMJE |
64 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | September 21, 2019 | ||
预计主要完成日期 | September 21, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | INCLUSION CRITERIA 1. Children age 6 to 16 years 2. The managing physician determines need for procedural sedation 3. Parents will sign a consent form and children will sign an assent form EXCLUSION CRITERIA 1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, inability to communicate) 2. Triage category 1 (resuscitation) 3. Facial features or injury prohibiting wearing the VR goggles | ||
性别 |
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年龄 | 最小年龄:6 Years ,最大年龄:16 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | Canada | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Ran Goldman,University of British Columbia | ||
研究赞助商 ICMJE | University of British Columbia | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | University of British Columbia | ||
验证日期 | September 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |