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NCT Number: NCT07715539

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.

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Key information

Conditions

Dental Anxiety

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Video modelling group

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

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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