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NCT Number: NCT06612398

Effect of a Preparation Video on Preoperative Anxiety in Children Undergoing Dental Treatment Under GA

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).

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Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative preparation video

Behavioral

An animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home.

Primary outcomes

  1. modified Yale Preoperative Anxiety Scale

    Time frame: 1 day

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

  2. 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

  1. Face, Legs, Activity, Cry, Consolability scale

    Time frame: 1 day

    Observational pain scale, values (0-10) with higher scores indicating higher levels of pain

  2. Pediatric Anesthesia Emergence Delirium scale

    Time frame: 1 day

    Observational emergence delirium scale, values (0-20) with higher scores indicating higher levels of emergence delirium

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Collaborators

  • Jordan University of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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