A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Laceration Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain using the Faces Pain Scale - Revised.
研究概览
简要总结
Lacerations are a common reason for presentation to the Emergency Department and children needing laceration repair with sutures are experiencing pain and anxiety.
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 in addition to pharmacoanalgesia during a laceration repair procedure. Investigators will measure pain, anxiety, satisfaction, amount of analgesia and the length of procedure and compare between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 6 - <17 years
- •Arriving to the Emergency Department with a chief complaint of laceration
- •The managing physician determines need for repair with suture
- •Parents will sign a consent form and children will sign an assent form
排除标准
- •Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
- •Triage category 1 (resuscitation)
- •Facial features or injury prohibiting wearing VR goggles
研究组 & 干预措施
Virtual Reality
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during laceration repair with sutures.
干预措施: Virtual Reality (Device)
Control (Standard-of-Care)
Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.
结局指标
主要结局
Pain using the Faces Pain Scale - Revised.
时间窗: Pain is reported by children immediately following completion of the laceration repair
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.
次要结局
- Parent Satisfaction determined qualitatively by an open ended question(Satisfaction question is reported by parents immediately following completion of the laceration repair)
- Timing(Documented immediately after patient and family given discharge paperwork)
- Anxiety using the Venham Situational Anxiety Score(Anxiety is reported by children immediately following completion of the laceration repair)
- Patient Satisfaction determined qualitatively by an open ended question(Satisfaction question is reported by children immediately following completion of the laceration repair)
- Medication Dose(These will be recorded during the procedure and immediately following the procedure using the patient chart and nursing notes)
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