Virtual Reality for Educating and Reducing Preoperative Anxiety in Children - A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change in child anxiety
研究概览
简要总结
All of the tools currently available for preoperative preparation of children either use a third person approach (i.e., use media whereby they watch a video or look at pictures of another child receiving an anesthetic), provide tours at some time previous to the operation date, or are shown the equipment that they will encounter during their anesthetic. No preoperative programme currently allows the child to experience the entire chain of events from leaving the preoperative preparation area (and their parents), walking to the operating area, being initially prepared for and receiving anesthesia and recovering from anesthesia, in real time and from a first person perspective. As such the investigators are carrying out this study to assess whether virtual reality preoperative preparation is effective in reducing anxiety at induction of anesthesia.
详细描述
The investigators' goal in this study is to investigate the effects of virtual reality preoperative preparation on anxiety in children at induction of anesthesia. The hypothesis is that utilisation of this novel 1st person immersive preparatory method will lead to an enhanced understanding of what will happen to the child (in addition to what the environment looks and sounds like) when they have their anesthetic. The investigators believe this enhanced understanding and preparation will lead to the reduction in anxiety levels before and during the induction of anesthesia, and will also lead to a reduction in postoperative negative behaviour disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 6 -18
- •ASA physical status 1-3
- •Admitted for elective surgery (day case and inpatient cases)
- •Cognitively normal
排除标准
- •ASA physical status 4-5
- •Non-English speaking
- •Significant visual and auditory disorders not allowing them to use the technology
- •Mobility problems that would make using the technology difficult or harmful to them (i.e., reduced movement of neck)
- •Cognitive impairment
- •Postoperative PICU care anticipated
研究组 & 干预措施
slideshow
Participant receives traditional slideshow presentation for preoperative preparation
干预措施: slideshow (Behavioral)
virtual
Participant receives virtual reality presentation for preoperative preparation
干预措施: virtual (Behavioral)
结局指标
主要结局
Change in child anxiety
时间窗: Day of surgery, immediately preceding surgery
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Anxiety in children
时间窗: Day of surgery, immediately following consent
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
次要结局
- Induction compliance(Day of surgery, immediately preceding surgery)
- Anesthetic requirements(Day of surgery, intra-operatively)
- Post-hospitalization negative behaviours(Two to three days after surgery)
研究者
Clyde Matava
Staff Anesthesiologist
The Hospital for Sick Children