Effects of AI-Generated Animated Videos on Dental Anxiety in Children (AIVDAC)
15 juin 2026 mis à jour par: Gül Keskin, Alanya Alaaddin Keykubat University
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
144
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Antalya
-
Alanya, Antalya, Turquie (Türkiye), 07425
- Alanya Alaaddin Keykubat University Faculty of Dentistry
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Oui
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Venham's Picture Test (VPT)
Délai: 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)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Modified Child Dental Anxiety Scale - Faces Version (MCDASf)
Délai: 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)
Délai: 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)
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
17 février 2026
Achèvement primaire (Réel)
8 juin 2026
Achèvement de l'étude (Réel)
8 juin 2026
Dates d'inscription aux études
Première soumission
13 mai 2026
Première soumission répondant aux critères de contrôle qualité
13 mai 2026
Première publication (Réel)
19 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ALKU-PEDO-2026-1/10
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared publicly due to ethical considerations related to pediatric participants and institutional data protection policies.
De-identified aggregate data may be reported in publications.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .