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临床试验/CTRI/2024/05/067987
CTRI/2024/05/067987尚未招募不适用

A randomised controlled study evaluating augmented reality for alleviation of preoperative anxiety in paediatric patients undergoing surgery under general anaesthesia

Maulana Azad medical College1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年6月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
试验地点
1
主要终点
Proportion of patients having mYPAS-SF score more than 30 in augmented reality and control group before induction

研究概览

简要总结

Preoperative paediatric 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 by modified Yale Preoperative anxiety scale(mYPAS).  Augmented Reality is a newer, interact technology that allows users to simultaneously view the real world environment with digital image overlay. The aim of our study is to evaluate efficacy of Augmented Reality technology  in alleviating preoperative anxiety in paediatric patients of age group 2-7 years.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
2.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status 1-3 -Paediatric patients of age 2 years till 7 years.

排除标准

  • Patients with impaired vision or hearing or language barrier -Patients with developmental delay -Patients on preoperative sedative drugs -Patients asleep during preoperative monitoring period -Patients with history of previous anaesthesia exposure, chronic disease or growth retardation.

结局指标

主要结局

Proportion of patients having mYPAS-SF score more than 30 in augmented reality and control group before induction

时间窗: Before induction

次要结局

  • Paediatric induction compliance(During induction)
  • Time to induction of Anaesthesia(During induction)
  • Parental anxiety(1. Baseline)
  • Parental satisfaction(Post operative)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Nisha

Maulana Azad medical College

研究点 (1)

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