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
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Usability in Stage 4 (Applying the headset on the eyes of the child with software application) as measured by a five point scale.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 2-6 years of age
- •Patients arrived with a legal guardian to the emergency department
- •Parents will sign a consent form and children will agree verbally to participate
- •Triage category 4 or 5 (lowest acuity)
排除标准
- •Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, neurological or other condition limiting communication)
- •Facial features or injury prohibiting wearing the VR goggles
- •Painful procedures in the emergency before being approached (such as blood testing, IV, catheterization, immunization, laceration repair)
- •Child is suffering pain or distress at a level that prohibit focusing on the study for 20 minutes, as assessed by the research assistant
结局指标
主要结局
Usability in Stage 4 (Applying the headset on the eyes of the child with software application) as measured by a five point scale.
时间窗: 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: 1. - Child tries to use the headset themselves with no help 2. - Child helps the research assistant to put the headset on their face 3. - Child is passive while the research assistant to put the headset on their face 4. - Child resist by pushing the research assistant's hands 5. - Child significantly resist/ cry/ wave arms / push feet
次要结局
- Willingness to Return VR as measured by a three point scale(Recorded during Stage 6 of the procedure)
- Patient experience questions as measured by a 4 point scale and open ended question(Immediately after the intervention (within 10 minutes))
- Mood/Behaviors during Handling of VR rated 1-100 on a Visual analogue scale(Recorded during Stage 3 of intervention. Up to 1 minute while child handles and puts on headset.)
- Time of demonstration required by child measured in seconds(Recorded during Stage 1 of intervention, before child puts headset on. Up to 120 seconds.)
- Time using VR in minutes(Recorded during Stage 5 of the procedure. Up to 10 minutes.)
- Parent experience questions as measured by a 4 point scale and open ended question(Immediately after the intervention (within 10 minutes))
研究者
Ran Goldman
Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital
University of British Columbia