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临床试验/CTRI/2024/03/064251
CTRI/2024/03/064251尚未招募2/3 期

Evaluating the Impact of Pediatric Preanesthesia Preparation Animated Video Intervention on Alleviating Preoperative Anxiety in Children and Parents. A Randomized Controlled Pilot Study

Dr. Sampurnanand Medical College Jodhpur1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月27日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Child anxiety score

研究概览

简要总结

This pilot study addresses the development and assessment of a unique video, "Pediatric Preanesthesia Preparation” (CF-5526/2023), combining animation with educational content in Hindi, the national language. This four-minute video aims to alleviate preoperative anxiety by providing a virtual experience of the perioperative anesthesia procedure. The video can be freely shared and accessed on smartphones, tablets, or laptops. We hypothesize that the "Pediatric Preanesthesia Preparation" video will significantly reduce preoperative anxiety in children and their parents. By offering a realistic depiction of the anesthetic procedure, the video aims to address key concerns, including fear of cannulations, the unfamiliar OT environment, pain, and postoperative recovery, all presented in a familiar language.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • All patients age between 5-10 years of age, either gender undergoing elective surgery lasting less than 120 minutes.

排除标准

  • Parents refusal, emergency surgery/ not consenting/ ASA III or IV, syndromic children, general anesthesia exposures ≥2, children with significant cognitive impairment or developmental delays impairing language or vision, and children on psychotropic medications, chronic illness, day care surgery, children who don’t understand Hindi language.
  • Children who will not watch the whole video and interrupt it in between will be considered as dropouts.

结局指标

主要结局

Child anxiety score

时间窗: The day before surgery and during transport of children from preanaesthesia room to OR

次要结局

  • Parent anxiety score, Child fear score and Child behaviour score(The day before surgery before study intervention and during transport of the children from preanaesthesia score to OR)

研究者

发起方
Dr. Sampurnanand Medical College Jodhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Naveen Paliwal

Dr. Sampurnanand Medical College Jodhpur

研究点 (1)

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