How Young is Too Young for Virtual Reality? Determining Usability and Acceptability in Ages 2-6 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 |
Usability in Stage 4 (Applying the headset on the eyes of the child with software application) as measured by a five point scale.[ Time Frame: Recorded during Stage 4 of the procedure ] The research assistant will assess how the child reacts to wearing VR as measured by a five point scale: - Child tries to use the headset themselves with no help - Child helps the research assistant to put the headset on their face - Child is passive while the research assistant to put the headset on their face - Child resist by pushing the research assistant's hands - Child significantly resist/ cry/ wave arms / push feet |
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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 | How Young is Too Young for Virtual Reality? Determining Usability and Acceptability in Ages 2-6 in the Emergency Department | ||
正式标题 ICMJE | How Young is Too Young for Virtual Reality ? Determination of the Usability and Acceptability of Virtual Reality for Health Care Purposes Among Children 2-6 Years of Age in the Emergency Department | ||
简要概况 | Children who present to the emergency department often require painful procedures (intravenous catheterization, laceration repair, fracture reduction, etc.). Virtual reality (VR) has been presented as a way of managing pain and anxiety in children undergoing painful procedures but most studies are limited to children 6 or older. The present study seeks to determine the youngest age (2-6) of future subjects in research of VR and clinical care. Virtual Reality 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. Investigators will instruct and observe children age 2-6 in using a VR device and document how easy the device is to use for the child. The children will have the opportunity to select an application and play with the device for 10 minutes before being asked about their experience with the device. Parents/Guardians will also be asked about their child's experience with the device. |
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详细说明 | |||
研究类型 ICMJE | Observational | ||
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研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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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 | Not yet recruiting | ||
预计入组 ICMJE |
100 | ||
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 2-6 years of age 2. Patients arrived with a legal guardian to the emergency department 3. Parents will sign a consent form and children will agree verbally to participate 4. Triage category 4 or 5 (lowest acuity) Exclusion Criteria: 1. Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, neurological or other condition limiting communication) 2. Facial features or injury prohibiting wearing the VR goggles 3. Painful procedures in the emergency before being approached (such as blood testing, IV, catheterization, immunization, laceration repair) 4. Child is suffering pain or distress at a level that prohibit focusing on the study for 20 minutes, as assessed by the research assistant | ||
性别 |
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年龄 | 最小年龄:2 Years ,最大年龄:6 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
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 |