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
1 other identifier
interventional
94
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2026
CompletedFirst Submitted
Initial submission to the registry
March 25, 2026
CompletedFirst Posted
Study publicly available on registry
July 20, 2026
CompletedJuly 20, 2026
July 1, 2026
10 months
March 25, 2026
July 16, 2026
Conditions
Keywords
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
EXPERIMENTALChildren allocated to the intervention group received a cartoon-animated video designed to familiarise them with their first dental visit.
Control group
NO INTERVENTIONChildren 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.
Eligibility Criteria
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
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
- STUDY DIRECTOR
Mawia Bataineh
Jordan University of Science and Technology
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