The Impact of Distraction During Transition to the Operating Room and Anesthesia Induction Using a Novel Virtual Reality Software Program on Pediatric Perioperative Anxiolysis and Induction Compliance.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- modified Yale Preoperative Anxiety Scale
研究概览
简要总结
The aim of this study is to determine whether a software virtual reality (VR) program provided during transportation to anesthesia induction reduces anxiety before the procedure, and compliance in pediatric patients. This study aims to measure the anxiety of patients as they arrive before their procedure, when parting from their parents for transportation to the procedure room, and when anesthesia is provided. Compliance during anesthesia induction will also be monitored. Participants will be randomly placed into to one of two groups. Group 1 will receive standard care from a Certified Child Life Specialist prior to their surgery. Group 2 will receive standard care from a Certified Child Life Specialist and distraction with a novel virtual reality software program.
详细描述
The aim of this study is to determine whether a novel software virtual reality (VR) program provided during transition from periop to the procedure room and anesthesia induction reduces preoperative anxiety, and induction compliance in pediatric patients. This study aims to specifically monitor and measure the anxiety of patients as they arrive at the preoperative suite, when parting from their parents for transportation to the procedure room, and at induction of anesthesia. Compliance during anesthesia induction will also be monitored. Participants will be randomized to one of two groups. Group 1 will receive standard care during their surgery. Group 2 will receive standard care and distraction with a novel virtual reality software program. We hypothesize that anxiety will be reduced, and anesthesia compliance will improve for participants in Group 2.
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
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 5-17 years old.
- •Patients undergoing general anesthesia with mask induction for dental or gastrointestinal procedures.
排除标准
- •Cognitive impairment that will impact the use of the VR headset or interaction with the game.
- •Participants who cannot comfortably wear the VR headset.
- •Visual impairment that would hinder use of software program.
- •Patients receiving general anesthesia via IV.
- •Parent accompanies patient back for anesthesia induction.
研究组 & 干预措施
Virtual Reality Experimental
Standard CCLS care and distraction with Virtual Reality
干预措施: Standard Child Life Preparation and Support + Meta Quest 2 VR headset with Gurney Journey (a mixed reality experience) (Device)
Standard CCLS care
Standard CCLS care
干预措施: Standard Child Life Preparation and Support (Behavioral)
结局指标
主要结局
modified Yale Preoperative Anxiety Scale
时间窗: Perioperative, transport to operating room, in operating room
Observational scale used to measure patient anxiety at different time points. Higher scores mean the patient is displaying more anxiety. Scores range from 23.33 to 100.
Induction Compliance Checklist
时间窗: In operating room at induction
Used to measure and observe a patient's compliance with anesthesia induction. It uses a checklist of 10 items that correspond to negative behaviors that are frequently observed at such time, scoring 1 point for each measure on the checklist. The score is obtained by summing the scores for all the items (10 points maximum). Perfect anesthetic induction (with no negative behaviors) scores 0 points, suboptimal induction is scored between 1 and 4 and a score above 4 is considered as poor induction.
次要结局
- The Pediatric Behavioral Induction Assessment(After induction)
研究者
Aline Maddux
Physician, Critical Care
Children's Hospital Colorado