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The Effect of a Preparation Video Using " Cartoon Animated Video Modeling" on Preoperative Anxiety Among Pre-School Children During The First Dental Visit: A Randomized Clinical Trial

16 de julio de 2026 actualizado por: Jordan University of Science and Technology

The primary aim of this study is to evaluate the efficacy of cartoon animated video-modeling in reducing preoperative anxiety among pre-school children during the first dental visit. Secondary aims include assessing the effect on parental anxiety and overall parental satisfaction.

Participants will be randomly assigned to either the intervention group, which will watch an animated video modeling the dental visit, or the control group, which will receive standard pre-visit information. Anxiety levels will be measured at five different time points.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Background: The first dental visit can be a very challenging experience for children, and anxiety at this stage may influence behaviour during treatment and future dental attendance.

Non-pharmacological interventions such as animated video modelling may help reduce preoperative anxiety.

Aim: The primary aim of this study was to evaluate the efficacy of a cartoon animated video-modelling intervention in reducing preoperative anxiety among preschool children during their first dental visit. The secondary aim was to assess the effect of the intervention on parental anxiety.

Methods: This single-blinded randomised controlled trial was conducted at the Postgraduate Paediatric Dental Clinic at Jordan University of Science and Technology.

Ninety-four healthy children aged 4-6 years with no previous dental experience were randomly allocated to a video-modelling group or a control group (n = 47 per group).

Expected results: The study predicts animated videos will lower children's preoperative anxiety and improve the overall dental experience for both parent and child. This could lead to video modeling being used in pediatric dentistry, especially for low-income families, to reduce anxiety and improve patient outcomes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

94

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

      • Irbid, Jordán, 22110
        • Jordan University of Science and Technology

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:

  • Medically healthy children classified as American Society of Anesthesiologists (ASA) physical status I or II.

    • Age 4-6 years.
    • Children presenting to the JUST postgraduate paediatric dental clinic with no previous dental visits.

Exclusion Criteria:

  • Children with systemic medical conditions or with mental, cognitive, or intellectual disabilities.

    • Children with visual or hearing impairments.
    • Participants unwilling to complete subjective anxiety assessment scales due to elevated anxiety levels.
    • Children whose parents are unable to read or write.
    • Participants without access to internet services.
    • Children presenting with severe active dental pain and/or facial abscess, as these conditions may influence state anxiety.
    • Children with previous dental experience.

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 paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: video-modelling group
Children allocated to the intervention group received a cartoon-animated video designed to familiarise them with their first dental visit.
The cartoon-animated video followed a child character's journey from home to arrival at the clinic, introduction to the dentist, and progression through the dental visit. The video showed the child character progressing through the main stages of a routine dental visit, including seating in the dental chair, intra-oral examination, radiographic assessment in the radiography room, and preventive procedures.
Sin intervención: Control group
Children in the control group received routine care upon arrival at the clinic, which consisted of a verbal explanation of the planned procedures while in the waiting area.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in children's anxiety scores measured using the Modified Yale Preoperative Anxiety Scale
Periodo de tiempo: Upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5)
Children's anxiety was assessed using the Modified Yale Preoperative Anxiety Scale (m-YPAS), an observational behavioural scale evaluating anxiety-related behaviours across five domains: activity, vocalization, emotional expressivity, state of apparent arousal, and use of parents. Scores range from 23.33 to 100, with higher scores indicating greater anxiety. Assessments were conducted by a blinded research assistant upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5).
Upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the dental procedure (T4), and 10-15 minutes after completion of the procedure (T5)
Change in children's anxiety scores measured using the Visual Facial Anxiety Scale (VFAS)
Periodo de tiempo: Baseline (day prior to dental visit) through 10-15 minutes post-procedure
Children's self-reported anxiety was assessed using the Visual Facial Anxiety Scale (VFAS), a validated scale consisting of facial expressions representing increasing levels of anxiety. Children selected the face that best reflects their anxiety level at each time point. Assessments were conducted at baseline (T1), upon arrival at the clinic (T2), while seated in the dental chair (T3), immediately before the procedure (T4), and 10-15 minutes after completion of the procedure (T5). Scores range from 0 to 5, with higher scores indicating greater anxiety.
Baseline (day prior to dental visit) through 10-15 minutes post-procedure

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in parental anxiety scores measured using the State-Trait Anxiety Inventory State Subscale
Periodo de tiempo: Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)
Parental anxiety was assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-State), which measures situational anxiety at the time of assessment. Scores range from 20 to 80, with higher scores indicating greater anxiety. Parents completed the questionnaire on the day before the dental appointment (T1) and again 10-15 minutes after completion of the child's dental procedure (T5).
Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)

Colaboradores e Investigadores

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

Investigadores

  • Director de estudio: Mawia Bataineh, Jordan University of Science and Technology

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)

1 de febrero de 2025

Finalización primaria (Actual)

1 de diciembre de 2025

Finalización del estudio (Actual)

3 de marzo de 2026

Fechas de registro del estudio

Enviado por primera vez

25 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de julio de 2026

Publicado por primera vez (Actual)

20 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

20 de julio de 2026

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

16 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 20240602

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

It depends on the institution's policy on sharing results

Datos del estudio/Documentos

  1. Protocolo de estudio
    Comentarios de información: study protocol not published
  2. Formulario de consentimiento informado
    Comentarios de información: informed consent not published

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. .

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