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Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children

4 de noviembre de 2026 actualizado por: Didem ATABEK

Comparison of "Virtual Reality" (VR) and "Point-of-View" (POV) Video Modeling Techniques for Reducing Dental Anxiety in Children

Dental anxiety is common among children and may make dental treatment more difficult. This study aims to compare three non-pharmacological behavior guidance techniques for reducing dental anxiety and improving cooperation during invasive fissure sealant treatment in children aged 6-10 years.

Children who require an invasive fissure sealant on a mandibular first molar and meet the study eligibility criteria will be included. Participants will be randomly assigned to one of three groups. The first group will watch a 1.5-2-minute Point-of-View (POV) video showing the dental examination and treatment process from a child's perspective before the dental procedure. The second group will use virtual reality (VR) glasses during the procedure and watch age-appropriate animation or cartoon content as an active distraction technique. The control group will receive the standard Tell-Show-Do behavior guidance technique.

Dental anxiety, behavior, physiological responses, and pain will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), Facial Image Scale (FIS), Frankl Behavior Rating Scale, pulse rate, oxygen saturation, and Wong-Baker FACES Pain Rating Scale. A post-intervention satisfaction and experience questionnaire will also be administered to assess the children's experiences with the behavior guidance techniques.

The study is expected to provide comparative evidence regarding the effectiveness of POV video modeling and VR distraction compared with the standard Tell-Show-Do technique in managing dental anxiety and improving children's cooperation during dental treatment.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The Facial Image Scale (FIS) will be used to evaluate the child's anxiety at four predefined time points: while the child is waiting in the waiting area, after sitting in the dental unit before the behavior guidance technique, after application of the assigned behavior guidance technique, and after completion of the invasive fissure sealant procedure.

Pulse rate and oxygen saturation will also be recorded at the same four assessment time points using a pulse oximeter. The Frankl Behavior Rating Scale will be used to assess behavioral cooperation before and during the dental procedure. Immediately after completion of the invasive fissure sealant procedure, pain will be assessed using the Wong-Baker FACES Pain Rating Scale. A post-intervention satisfaction and experience questionnaire will also be administered to evaluate the child's experience and perceived comfort with the assigned behavior guidance technique.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

69

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

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

6 años a 10 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Children aged 6-10 years.
  • Children without any systemic or psychiatric disorder or special needs.
  • Children who do not require emergency dental treatment.
  • Children whose parent(s) provide written and/or verbal informed consent for participation in the study.
  • Children who agree to participate in the assigned intervention, including watching the POV video or using virtual reality (VR) glasses, as applicable.

Exclusion Criteria:

  • Children with a systemic or psychiatric disorder or special needs.
  • Children who require emergency dental treatment.
  • Children who refuse to use virtual reality (VR) glasses.

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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: POV Video Modeling Group

Participants in this group will watch a 1.5-2-minute Point-of-View (POV) video before the dental procedure. The video presents the dental examination and treatment process from a child's perspective and is designed to familiarize the child with the dental procedure before invasive fissure sealant treatment.

Participants will watch a 1.5-2-minute Point-of-View (POV) video before the dental procedure. The video presents the dental examination and treatment process from a child's perspective and is intended to familiarize the child with the dental procedure before invasive fissure sealant treatment.

Experimental: Virtual Reality (VR) Group

Participants in this group will use virtual reality (VR) glasses during the dental procedure. Age-appropriate animation or cartoon content will be presented through the VR glasses as an active distraction technique during invasive fissure sealant treatment.

Participants will use virtual reality (VR) glasses during the dental procedure. Age-appropriate animation or cartoon content will be presented through the VR glasses as an active distraction technique during invasive fissure sealant treatment.

Comparador activo: Tell-Show-Do Control Group

Participants in this group will receive the standard Tell-Show-Do behavior guidance technique before and during the invasive fissure sealant procedure. The child will be introduced to the dental procedure using the standard Tell-Show-Do approach.

Participants in the control group will receive the standard Tell-Show-Do behavior guidance technique before and during the invasive fissure sealant procedure. The child will be introduced to the dental procedure using the standard Tell-Show-Do approach.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Facial Image Scale (FIS) Score
Periodo de tiempo: Visit 1: Within 1 min after dental examination. Visit 2 (2 weeks later): (1) Before dental examination; (2) within 1 min after seating; (3) within 1 min after behavior guidance; (4) within 1 min after fissure sealant.

The Facial Image Scale (FIS) is a self-report measure used to assess dental anxiety in children. It consists of five facial images representing increasing levels of anxiety, scored from 1 to 5. A score of 1 indicates the least anxiety, whereas a score of 5 indicates the highest anxiety. Higher scores indicate greater dental anxiety and therefore a worse outcome.

FIS scores will be recorded at five time points. During the first visit, the FIS will be administered within 1 minute after completion of the dental examination. During the second visit, which will take place 2 weeks after the initial visit, FIS scores will be recorded at four time points: (1) in the waiting area immediately before the dental examination; (2) within 1 minute after the child is seated in the dental chair; (3) within 1 minute after completion of the assigned behavior guidance technique and before dental treatment; and (4) within 1 minute after completion of the invasive fissure sealant procedure.

Visit 1: Within 1 min after dental examination. Visit 2 (2 weeks later): (1) Before dental examination; (2) within 1 min after seating; (3) within 1 min after behavior guidance; (4) within 1 min after fissure sealant.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) Score
Periodo de tiempo: Visit 1: Within 5 min after dental examination. Visit 2 (2 weeks later): Within 5 min after fissure sealant procedure.

Dental fear and anxiety will be assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS), a 15-item scale scored from 15 to 75. Higher scores indicate greater dental fear and anxiety and a worse outcome. Scores are categorized as low (≤32), moderate (33-37), and high (≥38) dental anxiety. CFSS-DS scores will be recorded within 5 minutes after completion of the dental examination during the first visit and within 5 minutes after completion of the fissure sealant procedure during the second visit, which will take place 2 weeks after the initial visit.

Visit 1: Within 5 min after dental examination. Visit 2 (2 weeks later): Within 5 min after fissure sealant procedure.
Frankl Behavior Rating Scale Score
Periodo de tiempo: Visit 1: During the dental examination. Visit 2: Before the behavior guidance technique: during the dental examination; after the behavior guidance technique: Throughout the fissure sealant procedure, including at treatment completion.

The child's behavior will be assessed using the Frankl Behavior Rating Scale, which consists of four categories scored from 1 to 4: definitely negative (1), negative (2), positive (3), and definitely positive (4). Higher scores indicate more positive behavior and a better outcome.The child's behavior will be observed during the dental examination at the first visit and, at the second visit, during the dental examination before the behavior guidance technique and throughout the fissure sealant procedure, including at treatment completion. The second visit will take place 2 weeks after the initial visit.

Visit 1: During the dental examination. Visit 2: Before the behavior guidance technique: during the dental examination; after the behavior guidance technique: Throughout the fissure sealant procedure, including at treatment completion.
Pulse Rate
Periodo de tiempo: Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.

Pulse rate (beats per minute, bpm) will be measured at four time points during the second visit: (1) in the waiting area immediately before the dental examination; (2) within 1 minute after the child is seated in the dental chair; (3) within 1 minute after completion of the assigned behavior guidance technique and before dental treatment; and (4) within 1 minute after completion of the invasive fissure sealant procedure.

Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.
Oxygen Saturation (SpO2)
Periodo de tiempo: Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.

Oxygen saturation (SpO₂), expressed as a percentage (%), will be measured at four time points during the second visit: (1) in the waiting area immediately before the dental examination; (2) within 1 minute after the child is seated in the dental chair; (3) within 1 minute after completion of the assigned behavior guidance technique and before dental treatment; and (4) within 1 minute after completion of the invasive fissure sealant procedure. Changes in SpO₂ will be evaluated across these time points.

Visit 2: (1) In the waiting area, before dental examination; (2) within 1 min after seating in dental unit; (3) within 1 min after behavior guidance, before dental treatment; (4) within 1 min after fissure sealant.
Wong-Baker FACES Pain Rating Scale Score
Periodo de tiempo: Visit 2: Within 1 min after completion of the fissure sealant procedure.

Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale, scored from 0 to 10 in increments of 2 (0, 2, 4, 6, 8, and 10). A score of 0 indicates no pain, while 10 indicates the worst pain. Higher scores indicate greater pain intensity and a worse outcome. Pain will be assessed within 1 minute after completion of the invasive fissure sealant procedure during the second visit.

Visit 2: Within 1 min after completion of the fissure sealant procedure.
Satisfaction and Experience Questionnaire
Periodo de tiempo: Visit 2: Within 5 min after completion of the fissure sealant procedure (POV and VR groups only).

A post-intervention Satisfaction and Experience Questionnaire will be administered to participants in the POV Video Modeling and Virtual Reality (VR) groups within 5 minutes after completion of the fissure sealant procedure to assess their satisfaction, perceptions, and comfort regarding the assigned behavior guidance technique. Items will be answered with "Yes" or "No."

Visit 2: Within 5 min after completion of the fissure sealant procedure (POV and VR groups only).

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Didem Atabek, Prof. Dr., Gazi University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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)

20 de octubre de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

19 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de octubre de 2026

Publicado por primera vez (Actual)

26 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2025-2098

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .