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

15 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

144

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Turcja (Türkiye)
    • Antalya
      • Alanya, Antalya, Turcja (Türkiye), 07425
        • Alanya Alaaddin Keykubat University Faculty of Dentistry

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przypisanie czynnikowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny komparator: 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).
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny komparator: 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).
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny komparator: 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).
Behawioralne: 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.
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny komparator: 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).
Behawioralne: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Venham's Picture Test (VPT)
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Modified Child Dental Anxiety Scale - Faces Version (MCDASf)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Alanya Alaaddin Keykubat University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

17 lutego 2026

Zakończenie podstawowe (Rzeczywisty)

8 czerwca 2026

Ukończenie studiów (Rzeczywisty)

8 czerwca 2026

Daty rejestracji na studia

Pierwszy przesłany

13 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 maja 2026

Pierwszy wysłany (Rzeczywisty)

19 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ALKU-PEDO-2026-1/10

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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