A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain measured using the Faces Pain Scale - Revised.
研究概览
简要总结
Children often experience pain and anxiety during minor medical procedures. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.
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 local anesthetics during minor painful procedure in the Plastic Surgery clinic. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared 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 to < 17 years
- •Patients scheduled for minor elective plastic surgery procedure
- •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)
- •Facial features or injury prohibiting wearing the VR goggles
- •Procedure in the face, where the VR system may interfere with Plastic Surgeon work
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 an IV start.
干预措施: Virtual Reality (Device)
Control (Standard-of-Care)
Participants are distracted with Standard-of-Care by doctors and/or parents.
结局指标
主要结局
Pain measured using the Faces Pain Scale - Revised.
时间窗: Pain is reported by children immediately following completion of the minor plastic surgery procedure
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
- Anxiety using the Venham Situational Anxiety Score(Anxiety is reported by children immediately following completion of the minor plastic surgery procedure)
- Patient Use of Virtual Reality in the Future by Yes/No Question(Reported by children immediately following completion of the minor plastic surgery procedure)
- Patient Satisfaction determined by Global Rating Scale(Satisfaction questions are reported by children immediately following completion of the minor plastic surgery procedure)
- Timing(Documented immediately after patient and family given discharge instructions)
- Medication Dose(These will be recorded during the procedure and immediately following the procedure using the patient chart)
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