Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children
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 3, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | October 1, 2018 | ||
预计主要完成日期 | October 1, 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 |
Pain using the Faces Pain Scale - Revised[ Time Frame: Pain is reported by children immediately following completion of the immunization (within two minutes post-immunization). This scale should take less than one minute to complete. ] Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2. |
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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 During Immunizations in Children | ||
正式标题 ICMJE | A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Immunizations in Children | ||
简要概况 | Children need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly used. 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. This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care while receiving immunizations. Investigators will measure pain, anxiety and satisfaction. |
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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 | Not yet 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 | October 1, 2019 | ||
预计主要完成日期 | October 1, 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. Patients arriving to the immunization clinic for immunization. 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) 2. Facial features or injury prohibiting wearing the VR goggles 3. VR system may interfere with immunization | ||
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 | |||
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 | October 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 |