NCT07715539

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

10 months

First QC Date

March 25, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

Dental anxietybehavioral guidancepediatric dentistry

Outcome Measures

Primary Outcomes (2)

  • Change in children's anxiety scores measured using the Modified Yale Preoperative Anxiety Scale

    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)

    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 Outcomes (1)

  • Change in parental anxiety scores measured using the State-Trait Anxiety Inventory State Subscale

    Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)

Study Arms (2)

video-modelling group

EXPERIMENTAL

Children allocated to the intervention group received a cartoon-animated video designed to familiarise them with their first dental visit.

Behavioral: Video modelling group

Control group

NO INTERVENTION

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.

Interventions

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.

video-modelling group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

Related Publications (1)

  • Bahammam MA. Validity and reliability of an Arabic version of the state-trait anxiety inventory in a Saudi dental setting. Saudi Med J. 2016 Jun;37(6):668-74. doi: 10.15537/Smj.2016.6.13935.

    PMID: 27279514BACKGROUND

Related Links

Study Officials

  • Mawia Bataineh

    Jordan University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2026

First Posted

July 20, 2026

Study Start

February 1, 2025

Primary Completion

December 1, 2025

Study Completion

March 3, 2026

Last Updated

July 20, 2026

Record last verified: 2026-07

Locations