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Clinical Trials/NCT06612398
NCT06612398
Completed
N/A

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

King Abdullah University Hospital1 site in 1 country84 target enrollmentFebruary 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preoperative Anxiety
Sponsor
King Abdullah University Hospital
Enrollment
84
Locations
1
Primary Endpoint
modified Yale Preoperative Anxiety Scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
October 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

modified Yale Preoperative Anxiety Scale

Time Frame: 1 day

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

Visual Facial Anxiety Scale

Time Frame: 1 day

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

Secondary Outcomes

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

Study Sites (1)

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