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Effects of AI-Generated Animated Videos on Dental Anxiety in Children (AIVDAC)

13. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

144

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Turecko (Türkiye)
    • Antalya
      • Alanya, Antalya, Turecko (Türkiye), 07425
        • Nábor
        • Alanya Alaaddin Keykubat University Faculty of Dentistry
        • Kontakt:
        • Kontakt:
          • fatma yaman toktaşır, DDS, Research Assistant
          • Telefonní číslo: +905055881265
          • E-mail: yamanfatma07@gmail.com
        • Vrchní vyšetřovatel:
          • Gül Keskin, Assoc. Prof., DDS, PhD
        • Dílčí vyšetřovatel:
          • Fatma Yaman Toktaşır, DDS, Research Assistant

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: AI-Generated Animated Video Series
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.
Aktivní komparátor: 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).
Behaviorální: Tell-Show-Do (TSD) Technique
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.
Experimentální: 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.
Behaviorální: AI-Generated Animated Video Series
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.
Aktivní komparátor: 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).
Behaviorální: Tell-Show-Do (TSD) Technique
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.
Experimentální: 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.
Behaviorální: AI-Generated Animated Video Series
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.
Aktivní komparátor: 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).
Behaviorální: Tell-Show-Do (TSD) Technique
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.
Experimentální: 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.
Behaviorální: AI-Generated Animated Video Series
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.
Aktivní komparátor: 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).
Behaviorální: Tell-Show-Do (TSD) Technique
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Venham's Picture Test (VPT)
Časové okno: 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)
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Modified Child Dental Anxiety Scale - Faces Version (MCDASf)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Alanya Alaaddin Keykubat University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. února 2026

Primární dokončení (Odhadovaný)

30. června 2026

Dokončení studie (Odhadovaný)

30. června 2026

Termíny zápisu do studia

První předloženo

13. května 2026

První předloženo, které splnilo kritéria kontroly kvality

13. května 2026

První zveřejněno (Aktuální)

19. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ALKU-PEDO-2026-1/10

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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