- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596771
Effects of AI-Generated Animated Videos on Dental Anxiety in Children (AIVDAC)
Instrument-Specific Effects of an AI-Generated Animated Video Series on Dental Anxiety in Paediatric Patients: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate the overall effect of an artificial intelligence-generated, instrument-specific animated video series compared with the conventional Tell-Show-Do (TSD) technique on dental anxiety in children aged 4 to 8 years. The study will also investigate whether the anxiety-reducing effect differs according to the dental instrument introduced.
Researchers will compare the animated video series with the conventional Tell-Show-Do technique across four dental instruments: dental mirror, dental probe, micromotor handpiece, and saliva ejector.
Participants will be randomly assigned to one of the study groups. Children will either watch an instrument-specific animated educational video or receive the Tell-Show-Do technique related to a specific dental instrument. Dental anxiety levels will be evaluated using the Facial Image Scale (FIS), Venham Picture Test (VPT) and Modified Child Dental Anxiety Scale-Faces version (MCDASf), together with pulse rate and oxygen saturation levels, before and after the application procedure.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective, single-center, randomized controlled clinical trial will evaluate the effectiveness of an artificial intelligence-generated animated educational video series in reducing dental anxiety among children aged 4 to 8 years. The study uses a 2×4 factorial design to compare the animated video series with the conventional Tell-Show-Do (TSD) technique across four commonly used dental instruments: dental mirror, dental probe, micromotor handpiece, and saliva ejector.
Participants will be randomly assigned to one of eight study groups according to intervention type and dental instrument. Only healthy children with no previous dental treatment experience and a Frankl Behavior Rating Scale score of 3 or 4 will be included in the study. Children in the animation groups will watch an instrument-specific animated educational video, while children in the control groups will receive the conventional Tell-Show-Do technique for the same instrument.
Dental anxiety will be assessed using the Facial Image Scale (FIS), Venham Picture Test (VPT), and Modified Child Dental Anxiety Scale-Faces version (MCDASf). Physiological parameters including pulse rate and oxygen saturation levels will also be recorded before and after the application procedure.
The study aims to investigate both the overall effectiveness of the animated educational video series and the instrument-specific differences in anxiety reduction among pediatric dental patients.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Antalya
-
Alanya, Antalya, Turkey (Türkiye), 07425
- Recruiting
- Alanya Alaaddin Keykubat University Faculty of Dentistry
-
Contact:
- Gül Keskin, Assoc. Prof., DDS, PhD
- Phone Number: +90 5444468857
- Email: gul.keskin.@alanya.edu.tr
-
Contact:
- fatma yaman toktaşır, DDS, Research Assistant
- Phone Number: +905055881265
- Email: yamanfatma07@gmail.com
-
Principal Investigator:
- Gül Keskin, Assoc. Prof., DDS, PhD
-
Sub-Investigator:
- Fatma Yaman Toktaşır, DDS, Research Assistant
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 4-8 years
- Frankl Behaviour Rating Scale score of 3 or 4 (positive or definitely positive) at initial assessment
- No previous restorative or surgical dental treatment
- ASA physical status classification I or II
- Ability to communicate in Turkish
- Written informed consent from the parent or legal guardian
Exclusion Criteria:
- Confirmed neurodevelopmental disorder (e.g., autism spectrum disorder, attention-deficit/hyperactivity disorder)
- Clinically significant visual or hearing impairment
- Prior exposure to formal behaviour management conditioning programmes
- Requirement for emergency dental care at the study appointment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Animated Series - Dental Mirror
Children in this arm viewed a single episode of the AI-generated animated video series (~60 seconds) corresponding to the dental mirror, presented on a 10-inch tablet at 60 dB SPL in the dental waiting area prior to clinical examination.
The episode features a recurring maternal character and anthropomorphic dental germ characters that hide among tooth surfaces and are revealed and removed by the dental mirror.
|
An original four-episode animated video series produced using AI-assisted animation tools.
Each episode is approximately 60 seconds in duration and is designed around a single dental instrument, featuring a recurring maternal character and anthropomorphic dental germ characters whose mischievous behaviour is resolved through the action of the featured instrument.
Each child viewed only the single episode corresponding to the instrument assigned to their group.
|
|
Active Comparator: Tell-Show-Do - Dental Mirror
Children in this arm received the standard Tell-Show-Do technique (~4 minutes) applied specifically to the dental mirror, following a standardised script.
The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
|
The standard Tell-Show-Do technique applied specifically to the instrument assigned to each group.
The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
Each TSD session lasted approximately 4 minutes, matching the viewing time of the single animated episode in the intervention condition.
|
|
Experimental: Animated Series - Dental Probe
Children in this arm viewed a single episode of the AI-generated animated video series (~60 seconds) corresponding to the dental probe.
The episode features a recurring maternal character and anthropomorphic dental germ characters that jump between teeth and become wedged in interproximal spaces, then are dislodged and removed by the dental probe.
|
An original four-episode animated video series produced using AI-assisted animation tools.
Each episode is approximately 60 seconds in duration and is designed around a single dental instrument, featuring a recurring maternal character and anthropomorphic dental germ characters whose mischievous behaviour is resolved through the action of the featured instrument.
Each child viewed only the single episode corresponding to the instrument assigned to their group.
|
|
Active Comparator: Tell-Show-Do - Dental Probe
Children in this arm received the standard Tell-Show-Do technique (~4 minutes) applied specifically to the dental probe, following a standardised script.
The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
|
The standard Tell-Show-Do technique applied specifically to the instrument assigned to each group.
The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
Each TSD session lasted approximately 4 minutes, matching the viewing time of the single animated episode in the intervention condition.
|
|
Experimental: Animated Series - Micromotor Handpiece
Children in this arm viewed a single episode of the AI-generated animated video series (~60 seconds) corresponding to the micromotor handpiece.
The episode features a recurring maternal character and anthropomorphic dental germ characters that eat and rest on a tooth surface, then are tickled and removed by the micromotor handpiece.
|
An original four-episode animated video series produced using AI-assisted animation tools.
Each episode is approximately 60 seconds in duration and is designed around a single dental instrument, featuring a recurring maternal character and anthropomorphic dental germ characters whose mischievous behaviour is resolved through the action of the featured instrument.
Each child viewed only the single episode corresponding to the instrument assigned to their group.
|
|
Active Comparator: Tell-Show-Do - Micromotor Handpiece
Children in this arm received the standard Tell-Show-Do technique (~4 minutes) applied specifically to the micromotor handpiece, following a standardised script.
The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
|
The standard Tell-Show-Do technique applied specifically to the instrument assigned to each group.
The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
Each TSD session lasted approximately 4 minutes, matching the viewing time of the single animated episode in the intervention condition.
|
|
Experimental: Animated Series - Saliva Ejector
Children in this arm viewed a single episode of the AI-generated animated video series (~60 seconds) corresponding to the saliva ejector.
The episode features a recurring maternal character and anthropomorphic dental germ characters that flood the mouth with water and swim freely, then are eliminated by the suction of the saliva ejector.
|
An original four-episode animated video series produced using AI-assisted animation tools.
Each episode is approximately 60 seconds in duration and is designed around a single dental instrument, featuring a recurring maternal character and anthropomorphic dental germ characters whose mischievous behaviour is resolved through the action of the featured instrument.
Each child viewed only the single episode corresponding to the instrument assigned to their group.
|
|
Active Comparator: Tell-Show-Do - Saliva Ejector
Children in this arm received the standard Tell-Show-Do technique (~4 minutes) applied specifically to the saliva ejector, following a standardised script.
The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
|
The standard Tell-Show-Do technique applied specifically to the instrument assigned to each group.
The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
Each TSD session lasted approximately 4 minutes, matching the viewing time of the single animated episode in the intervention condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Venham's Picture Test (VPT)
Time Frame: Baseline (T0) and immediately post-intervention (T1)
|
An eight-item pictorial anxiety measure requiring children to select the image (anxious or non-anxious figure) that best represents their feelings (score range 0-8).
|
Baseline (T0) and immediately post-intervention (T1)
|
|
Facial Image Scale (FIS)
Time Frame: Baseline (T0) and immediately post-intervention (T1)
|
A five-item pictorial self-report scale depicting faces ranging from very happy (1) to very unhappy (5), validated for use in children aged ≥ 4 years with limited literacy.
|
Baseline (T0) and immediately post-intervention (T1)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Child Dental Anxiety Scale - Faces Version (MCDASf)
Time Frame: Baseline (T0) and immediately post-intervention (T1)
|
A six-item self-report scale using facial images (score range 6-30), validated for the paediatric dental setting.
|
Baseline (T0) and immediately post-intervention (T1)
|
|
Heart Rate (HR)
Time Frame: Baseline (T0) and immediately post-intervention (T1)
|
Measured using a paediatric pulse oximeter positioned on the index finger of the non-dominant hand.
The mean of two consecutive readings was used for analysis.
|
Baseline (T0) and immediately post-intervention (T1)
|
|
Peripheral Oxygen Saturation (SpO₂)
Time Frame: Baseline (T0) and immediately post-intervention (T1)
|
Measured using a paediatric pulse oximeter positioned on the index finger of the non-dominant hand.
The mean of two consecutive readings was used for analysis.
|
Baseline (T0) and immediately post-intervention (T1)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALKU-PEDO-2026-1/10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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