- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07715539
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
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
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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Irbid, Jordán, 22110
- Jordan University of Science and Technology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
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
¿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 |
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Experimental: video-modelling group
Children allocated to the intervention group received a cartoon-animated video designed to familiarise them with their first dental visit.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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)
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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).
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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)
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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
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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.
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Baseline (day prior to dental visit) through 10-15 minutes post-procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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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)
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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).
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Day before the dental appointment (T1) and 10-15 minutes after completion of the child's dental procedure (T5)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Mawia Bataineh, Jordan University of Science and Technology
Publicaciones y enlaces útiles
Publicaciones Generales
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 20240602
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Datos del estudio/Documentos
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Protocolo de estudio
Comentarios de información: study protocol not published
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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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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