Perioperative Virtual Reality for Pediatric Anesthesia: Pediatric Distraction on Induction With Virtual Reality (PEDI-VR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Perioperative Pediatric Anxiety (Change From Baseline)
研究概览
简要总结
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial.
详细描述
The goal of this study is to evaluate the use of immersive audiovisual distraction and virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during induction of anesthesia in pediatric patients for elective surgery in a randomized clinical trial. We will be enrolling patients age 5-12 years presenting for elective surgery.
Patients will be randomized to one of two groups: (1) virtual reality headset with routine anesthetic care and (2) routine anesthetic care only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 5-12 years
- •Patients present in preoperative area for induction of general anesthesia for an elective surgery or procedure
排除标准
- •Patients with injuries to the head/face that would prohibit wearing of headsets
- •Patients with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
- •Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
- •Patients with a history of or current symptoms of vertigo
- •Patients who are blind
- •Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
- •Patients on whom the VR headset does not fit appropriately
- •Non-English speaking patients (due to limited availability of non-English study documents and consents)
结局指标
主要结局
Perioperative Pediatric Anxiety (Change From Baseline)
时间窗: (Day 0 + 30 minutes on average from initial baseline) During mask induction
Modified Yale Preoperative Anxiety Scale (Observational measure of anxiety in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents); Total range 0 to 100 with higher scores indicating greater anxiety)
次要结局
- Perioperative Parental Anxiety (Change From Baseline)((Day 0 + 45 minutes on average from initial baseline) After mask induction)
- Induction Compliance Checklist((Day 0 + 30 minutes on average from initial baseline) During mask induction)
- Parental Satisfaction((Day 0 + 45 minutes on average from initial baseline) After mask induction)