A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Immunizations 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 using the Faces Pain Scale - Revised
研究概览
简要总结
Children need routine immunizations which can be a painful procedure associated with pain and anxiety. This is particularly true of children visiting the children's hospital to visit relatives during flu season. No topical anesthetic or oral analgesia is commonly used.
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 while receiving immunizations. Investigators will measure pain, anxiety and satisfaction.
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 16 years
- •Patients arriving to the immunization clinic for immunization.
- •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
- •VR system may interfere with immunization
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 immunization.
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 immunization (within two minutes post-immunization). This scale should take less than one minute to complete.
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 immunization (within two minutes post-immunization). This scale should take less than one minute to complete.)
- Medication Dose(These will be recorded during the procedure and immediately following the procedure using the patient chart)
- Length of time of procedure(This will be documented during the procedure)
- Patient Satisfaction determined by Global Rating Scale(Satisfaction question is reported by children immediately following completion of the immunization (within 5 minutes post immunization))
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