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临床试验/NCT06612398
NCT06612398已完成不适用

Effect of a Preoperative Preparation Video on Preoperative Anxiety Among Children Undergoing Dental Treatment Under General Anesthesia

King Abdullah University Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
modified Yale Preoperative Anxiety Scale

研究概览

简要总结

The present study investigated the effect of an animated preoperative preparation video in mitigating preoperative anxiety among children receiving comprehensive dental treatment under General Anesthesia (GA).

详细描述

This randomised controlled trial, conducted at King Abdullah University Hospital (KAUH) over an eight-month period from February to October 2023, focused on children aged four to seven years undergoing comprehensive dental treatment under GA. Participants were randomly assigned to either the control group or the study group. Participants in the control group received the standard care provided upon arrival at the Day Case Unit (DCU) at KAUH, involving only a verbal explanation of the anaesthesia induction process. In contrast, on the night before the surgery, participants in the study group were presented with an animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home. Additionally, all parents watched the video alongside their children and provided positive comments on its content. The primary outcome assessed was the children's preoperative anxiety measured by modified Yale Preoperative Anxiety Scale (m-YPAS) and Visual Facial Anxiety Scale (VFAS), allowing for an evaluation of the intervention's impact.

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
Single (Outcomes Assessor)

盲法说明

Research Assistant who evaluated patient's anxiety levels did not know who watched the intervention and who did not.

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who are healthy, with American Society of Anesthesiologists (ASA) Grade 1 and 2 status.
  • Age 4-7 years.
  • Children undergoing GA for the first time who require comprehensive dental rehabilitation.

排除标准

  • Presence of a systemic disease, as well as mental, cognitive, and intellectual disabilities.
  • Presence of visual or auditory disability.
  • Participants who refuse to answer subjective scales due to heightened anxiety levels.
  • Participants with no access to internet services.
  • Presence of active severe dental pain and/or facial abscess as it could affect the participant's state anxiety.

结局指标

主要结局

modified Yale Preoperative Anxiety Scale

时间窗: 1 day

Observational anxiety scale, values (23.3-100) with higher scores indicating higher levels of anxiety

Visual Facial Anxiety Scale

时间窗: 1 day

Self-report anxiety scale, values (0-10) with higher scores indicating higher levels of anxiety

次要结局

  • Face, Legs, Activity, Cry, Consolability scale(1 day)
  • Pediatric Anesthesia Emergence Delirium scale(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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