- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07721805
Social Perception of Microtia
The Social Perception of Microtia and Auricular Reconstruction in Children.
Rationale: Microtia is a congenital craniofacial condition characterized by the underdevelopment of the external ear. Children with microtia become aware of their deformity at a young age, and this awareness intensifies in school, where they often face social comparison. This can impact both their mental well-being and social standing. In this process, not only their self-image but also others' perceptions play important roles. Given the significant time children spend with peers, it is crucial to investigate how children of similar ages perceive microtia and whether this perception changes after auricular reconstruction.
Objective: To examine the social perception of children regarding peers with microtia and auricular reconstruction.
Study design: The study is of cross-sectional nature. Study population: The study population consists of primary and secondary school children aged 6 to 18 years old.
Intervention: All children will be shown one of the following photos: a child with a normal ear, a child with preoperative microtia, or a child with a postoperative reconstructed ear. Subsequently, all children will evaluate the photo they have seen using 7 questions based on a visual analogue scale (VAS) ranging from a score of 0 to 10.
Study endpoints: The study includes several endpoints. It will examine children's perception of peers with a normal ear, microtia, or a reconstructed ear in terms of the following social attributes: athleticism, confidence, friendliness, health, intelligence, popularity and willingness to interact. Additionally, it will explore whether there is a difference in the perception of primary school children and secondary school children regarding the above-mentioned social attributes.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Provincie Groningen
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Groningen, Provincie Groningen, Países Bajos, 9713 GZ
- University Medical Center Groningen
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Attending primary or secondary school
Exclusion Criteria:
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Children aged 6-17 years were eligible for participation.
Attending primary or secondary school
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Difference in social perception scores
Periodo de tiempo: The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.
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The primary outcome was the difference in social perception scores between the three image groups.
Responses will be recorded using a visual analogue scale (VAS) ranging from 0 to 100, with higher scores indicating a more favorable perception of the attribute.
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The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Differences in social perception scores between primary and secondary school
Periodo de tiempo: The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.
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Secondary analyses examined differences in social perception scores between primary and secondary school students.
Responses will be recorded using a visual analogue scale (VAS) ranging from 0 to 100, with higher scores indicating a more favorable perception of the attribute.
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The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Myrthe KS Hol, Prof. dr., University Medical Center Groningen
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25059
Plan de datos de participantes individuales (IPD)
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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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