Effects of AI-Generated Animated Videos on Dental Anxiety in Children (AIVDAC)
15 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
144
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Antalya
-
Alanya, Antalya, Turquía (Türkiye), 07425
- Alanya Alaaddin Keykubat University Faculty of Dentistry
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
|
Comparador activo: 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.
|
|
Comparador activo: 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.
|
|
Comparador activo: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Venham's Picture Test (VPT)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Modified Child Dental Anxiety Scale - Faces Version (MCDASf)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de febrero de 2026
Finalización primaria (Actual)
8 de junio de 2026
Finalización del estudio (Actual)
8 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
13 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de mayo de 2026
Publicado por primera vez (Actual)
19 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ALKU-PEDO-2026-1/10
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .