Virtual Reality Distraction During Pediatric Intravenous Line Placement
Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study
研究概览
详细说明
Children often describe procedures involving needles as the most stressful portion of the hospital experience. 1,2 Many studies involving the perception of pain have highlighted the importance of attention for the perception of pain, and, conversely, the benefit of distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a number of different ways. 5,6 While small studies have demonstrated the use of VR to be effective in diminishing pain during intravenous (IV) placement for outpatient imaging in pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR during venipuncture and IV placement also frequently focus on self-reported or parent-reported pain, rather than objectively quantifying number of IV sticks and time to successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have not been well-established, with some studies citing benefits only in patients over 10 years of age, and others showing improvements in all age groups.7,9,10
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Texas
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Austin、Texas、美国、78723
- 招聘中
- Dell Children's Medical Center of Central Texas
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接触:
- Matthew Wilkinson, MD
- 电话号码:512-547-8362
- 邮箱:mhwilkinson@ascension.org
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient aged 4-17 years
- Requiring IV placement
- Child Life unavailable
Exclusion Criteria:
- Previous enrollment in the study
- Physically/ developmentally unable to tolerate headset
- Skin/eye pathology
- Critically ill patient
- Language other than English or Spanish
- Student Nurse placing IV
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:IV placement no Virtual reality
Patient will have IV placed in traditional manner, with no virtual reality headset
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实验性的:IV placement with Virtual Reality
Patient will have IV placed with Virtual Reality headset distraction
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Virtual Reality Headset applied to the patient during placement of IV.
Control is patient group without headset applied.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Successful IV placement with first attempt
大体时间:6 months
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success in first attempt in VR group vs non VR group
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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number of attempts before successfully establishing IV
大体时间:6 months
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number of attempts before successful IV placement in VR group vs non VR group
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6 months
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time to establishing successful IV
大体时间:6 months
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time to establishing successful IV in VR group vs non VR group
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6 months
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Pre vs Post FACES revised pain scale parents
大体时间:6 months
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Pre vs Post FACES pain scale in VR group vs non VR group
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6 months
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Pre vs Post FACES revised pain Scale patients
大体时间:6 months
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Pre vs Post FACES pain scale in VR group vs non VR group
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6 months
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Pre vs Post Likert-Type Anxiety Scale - parents
大体时间:6 months
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Pre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group
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6 months
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Pre vs Post Likert-Type Anxiety Scale- patients
大体时间:6 months
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Pre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group
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6 months
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age range of patients that tolerate VR
大体时间:6 months
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Which of evaluated age range of 4-17 years tolerate VR placement
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6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ASalinas
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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