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

September 24, 2024 updated by: King Abdullah University Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan
        • Jordan University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
Participants received the standard care provided upon arrival and being admitted to the hospital, involving only a verbal explanation of the anaesthesia induction process.
Experimental: Preoperative preparation video
On the night before the surgery, participants 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.
Behavioral: Preoperative preparation video
An animated video illustrating the story of a child's journey through the hospital facilities, including the anaesthesia induction, and the postoperative return home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Yale Preoperative Anxiety Scale
Time Frame: 1 day
Observational anxiety scale, values (23.3-100) with higher scores indicating higher levels of anxiety
1 day
Visual Facial Anxiety Scale
Time Frame: 1 day
Self-report anxiety scale, values (0-10) with higher scores indicating higher levels of anxiety
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Face, Legs, Activity, Cry, Consolability scale
Time Frame: 1 day
Observational pain scale, values (0-10) with higher scores indicating higher levels of pain
1 day
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah University Hospital

Collaborators

Jordan University of Science and Technology

Investigators

  • Study Chair: Mawia Bataineh, Doctor, Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72/149/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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