A Pragmatic Randomized Controlled Trial of Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization
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 often need an intravenous catheter placement for delivery of fluids and medications, a procedure associated with pain and anxiety. In the Emergency Department topical anesthetics are frequently 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 in addition to topical anaesthetics during IV placement procedure. Investigators will measure pain, anxiety and satisfaction, amount of analgesics used and the level of success in placing the IV 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
- •The managing physician determines a need for an intravenous catheterization (IV) 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, autism, others)
- •Triage Category 1 (resuscitation)
- •Facial features or injury prohibiting wearing the VR goggles
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 IV start
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
- Patient Satisfaction determined by Global Rating Scale(Satisfaction questions are reported by children immediately following completion of the IV start)
- Parent Satisfaction determined qualitatively by an open ended question(Satisfaction question is reported by parents immediately following completion of the IV start)
- Number of IV Trials Until Success(This number will be collected during the procedure)
- Anxiety using the Venham Situational Anxiety Score(Anxiety is reported by children immediately following completion of the IV start)
- Patient Satisfaction determined qualitatively by an open ended question(Satisfaction questions are reported by children immediately following completion of the IV start)
- Medication Dose(These will be recorded during the procedure and immediately following the procedure using the patient chart and nursing notes)
- Timing(Documented immediately after patient and family given discharge paperwork)
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