Comparative evaluation of virtual reality and augmented reality as distraction techniques on preoperative anxiety in pediatric patients.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in preoperative anxiety (mYPAS score).
研究概览
简要总结
Preoperative pediatric anxiety is common and can have negative psychological impact on children undergoing anaesthesia and surgery. Various audiovisual distraction techniques like Virtual reality have proven to be effective in lowering anxiety as assessed my modified yale perioperative scale(mYPAS). Augmented reality is a newer, interactive technology that allows users to simultaneously view the real world environment with digital image overlay. The aim of our study is to evaluate and compare virtual reality and augmented reality in pediatric patients aged 4-10 years old.
Our primary outcome is to assess change in preoperative anxiety from baseline to induction using mYPAS scale. Our secondary outcomes are to measure pediatric induction compliance using induction compliance checklist score, parental anxiety using state trait anxiety inventory score, parental satisfaction using parental and patient satisfaction questionnaires, time to loss of eyelash reflex and time to central miosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 4.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status I-III.
排除标准
- •1.Patients with injuries to head and face that would interfere in wearing headsets.
- •Skin infections and open wounds on face/head.
- •Inability to visualise AR/VR applications.
- •Patients in whom VR headsets do not fit appropriately.
结局指标
主要结局
Change in preoperative anxiety (mYPAS score).
时间窗: Baseline to induction.
次要结局
- Parental satisfaction using parental & patient satisfaction scores(after induction)
- Time to loss of eyelash reflex(after induction till loss of eyelash reflex)
- Parental anxiety using state trait anxiety inventory score. (STAI)(after induction.)
- Pediatric induction compliance using induction compliance checklist score.(During induction of general anaesthesia.)
- Time to central miosis(after induction till central miosis)
- Change in preoperative anxiety using mYPAS score.(during induction.)