The Effect of a Preparation Video Using " Cartoon Animated Video Modeling" on Preoperative Anxiety Among Pre-School Children During The First Dental Visit: A Randomized Clinical Trial

The primary aim of this study is to evaluate the efficacy of cartoon animated video-modeling in reducing preoperative anxiety among pre-school children during the first dental visit. Secondary aims include assessing the effect on parental anxiety and overall parental satisfaction.

Participants will be randomly assigned to either the intervention group, which will watch an animated video modeling the dental visit, or the control group, which will receive standard pre-visit information. Anxiety levels will be measured at five different time points.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: The first dental visit can be a very challenging experience for children, and anxiety at this stage may influence behaviour during treatment and future dental attendance.

Non-pharmacological interventions such as animated video modelling may help reduce preoperative anxiety.

Aim: The primary aim of this study was to evaluate the efficacy of a cartoon animated video-modelling intervention in reducing preoperative anxiety among preschool children during their first dental visit. The secondary aim was to assess the effect of the intervention on parental anxiety.

Methods: This single-blinded randomised controlled trial was conducted at the Postgraduate Paediatric Dental Clinic at Jordan University of Science and Technology.

Ninety-four healthy children aged 4-6 years with no previous dental experience were randomly allocated to a video-modelling group or a control group (n = 47 per group).

Expected results: The study predicts animated videos will lower children's preoperative anxiety and improve the overall dental experience for both parent and child. This could lead to video modeling being used in pediatric dentistry, especially for low-income families, to reduce anxiety and improve patient outcomes.

Study Type

Interventional

Enrollment (Actual)

94

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

      • Irbid, Jordan, 22110
        • 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:

  • Medically healthy children classified as American Society of Anesthesiologists (ASA) physical status I or II.

    • Age 4-6 years.
    • Children presenting to the JUST postgraduate paediatric dental clinic with no previous dental visits.

Exclusion Criteria:

  • Children with systemic medical conditions or with mental, cognitive, or intellectual disabilities.

    • Children with visual or hearing impairments.
    • Participants unwilling to complete subjective anxiety assessment scales due to elevated anxiety levels.
    • Children whose parents are unable to read or write.
    • Participants without access to internet services.
    • Children presenting with severe active dental pain and/or facial abscess, as these conditions may influence state anxiety.
    • Children with previous dental experience.

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
Experimental: video-modelling group
Children allocated to the intervention group received a cartoon-animated video designed to familiarise them with their first dental visit.
The cartoon-animated video followed a child character's journey from home to arrival at the clinic, introduction to the dentist, and progression through the dental visit. The video showed the child character progressing through the main stages of a routine dental visit, including seating in the dental chair, intra-oral examination, radiographic assessment in the radiography room, and preventive procedures.
No Intervention: Control group
Children in the control group received routine care upon arrival at the clinic, which consisted of a verbal explanation of the planned procedures while in the waiting area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in children's anxiety scores measured using the Modified Yale Preoperative Anxiety Scale
Time Frame: Upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5)
Children's anxiety was assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS), an observational behavioural scale evaluating anxiety-related behaviours across five domains: activity, vocalization, emotional expressivity, state of apparent arousal, and use of parents. Scores range from 23.33 to 100, with higher scores indicating greater anxiety. Assessments were conducted by a blinded research assistant upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5).
Upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5)
Change in children's anxiety scores measured using the Visual Facial Anxiety Scale (VFAS)
Time Frame: Baseline (day prior to dental visit) through 10-15 minutes post-procedure
Children's self-reported anxiety was assessed using the Visual Facial Anxiety Scale (VFAS), a validated scale consisting of facial expressions representing increasing levels of anxiety. Children selected the face that best reflects their anxiety level at each time point. Assessments were conducted at baseline (T1), upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the procedure (T4), and 10-15 minutes after completion of the procedure (T5). Scores range from 0 to 5, with higher scores indicating greater anxiety.
Baseline (day prior to dental visit) through 10-15 minutes post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in parental anxiety scores measured using the State-Trait Anxiety Inventory State Subscale
Time Frame: Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)
Parental anxiety was assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-State), which measures situational anxiety at the time of assessment. Scores range from 20 to 80, with higher scores indicating greater anxiety. Parents completed the questionnaire on the day before the dental appointment (T1) and again 10-15 minutes after completion of the child's dental procedure (T5).
Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)

Collaborators and Investigators

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

Investigators

  • Study Director: Mawia Bataineh, 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.

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, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

March 3, 2026

Study Registration Dates

First Submitted

March 25, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 20240602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It depends on the institution's policy on sharing results

Study Data/Documents

  1. Study Protocol
    Information comments: study protocol not published
  2. Informed Consent Form
    Information comments: informed consent not published

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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