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Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department

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合作者:
信息的提供 (责任方):
Ran Goldman,University of British Columbia
September 20, 2018
October 2, 2018
October 2, 2018
September 21, 2018
September 21, 2019   (主要结果测量的最终数据收集日期)
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.

与当前相同
  • Emergence Phenomenon as measured by yes/no questions regarding participant experience.[ Time Frame: Immediately after the procedure and by phone the next day ]
    Patients will be asked whether they experienced nightmares, day-dreaming, or feeling unwell. Number of patients who experienced these negative emergence phenomenon will be tabulated and compared across groups.
  • Satisfaction among Children by global rating scale[ Time Frame: Immediately after the procedure ]
    Children will be asked "On a scale of 0-10, how did the procedure go?" A score of 0 represents not very well and a score of 10 represents very well.
  • Satisfaction among Guardians by global rating scale[ Time Frame: Immediately after the procedure ]
    Guardians will be asked "On a scale of 0-10, how did the procedure go?" A score of 0 represents not very well and a score of 10 represents very well.
  • Satisfaction among Emergency Staff by global rating scale[ Time Frame: Immediately after the procedure ]
    Emergency Staff will be asked "How satisfied are you with how the procedure went?" A score of 0 represents not very well and a score of 10 represents very well.
  • Type and dose of medication[ Time Frame: Intraoperative ]
    Amount of medication and what medications were used will be gathered from the nursing notes.
  • Time difference of the procedure[ Time Frame: Intraoperative ]
    Time the procedure takes to complete with or without VR will be recorded to determine if there is any difference.
  • Length of stay in the Emergency Department[ Time Frame: Intraoperative ]
    Length of stay in the Emergency Department will also be recorded. This will be determined by the intake time noted by triage and the discharge time as witnessed by research assistant or, if unseen, by the time noted on the discharge paperwork.
 
Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department

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.

Interventional
N/A
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
  • Device: Virtual Reality
    Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
  • Experimental: Virtual Reality
    Participants are distracted by wearing the virtual reality headset and watching a roller coaster app while undergoing procedural sedation
  • No Intervention: Standard-of-Care
    Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.
 
Recruiting
64
与当前相同
September 21, 2019
September 21, 2019   (主要结果测量的最终数据收集日期)
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
参与研究的性别: All
最小年龄:6 Years ,最大年龄:16 Years  
没有
Canada
 
No
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
计划分享 IPD:
Ran Goldman,University of British Columbia
University of British Columbia
Principal Investigator: Ran Goldman, MD University of British Columbia
University of British Columbia
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
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