Effects of AI-Generated Animated Videos on Dental Anxiety in Children (AIVDAC)
13 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
144
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Antalya
-
Alanya, Antalya, Turchia (Türkiye), 07425
- Reclutamento
- Alanya Alaaddin Keykubat University Faculty of Dentistry
-
Contatto:
- Gül Keskin, Assoc. Prof., DDS, PhD
- Numero di telefono: +90 5444468857
- Email: gul.keskin.@alanya.edu.tr
-
Contatto:
- fatma yaman toktaşır, DDS, Research Assistant
- Numero di telefono: +905055881265
- Email: yamanfatma07@gmail.com
-
Investigatore principale:
- Gül Keskin, Assoc. Prof., DDS, PhD
-
Sub-investigatore:
- Fatma Yaman Toktaşır, DDS, Research Assistant
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Venham's Picture Test (VPT)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Modified Child Dental Anxiety Scale - Faces Version (MCDASf)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 febbraio 2026
Completamento primario (Stimato)
30 giugno 2026
Completamento dello studio (Stimato)
30 giugno 2026
Date di iscrizione allo studio
Primo inviato
13 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
13 maggio 2026
Primo Inserito (Effettivo)
19 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ALKU-PEDO-2026-1/10
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Pediatric Dental Anxiety
-
Cairo UniversitySconosciutoBlack Stain Dental, Dental Black Stain, Black Stain*, Black Stain, Tooth Stains