- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Provincie Groningen
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Groningen, Provincie Groningen, Pays-Bas, 9713 GZ
- University Medical Center Groningen
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Attending primary or secondary school
Exclusion Criteria:
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Children aged 6-17 years were eligible for participation.
Attending primary or secondary school
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Difference in social perception scores
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Differences in social perception scores between primary and secondary school
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Myrthe KS Hol, Prof. dr., University Medical Center Groningen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 25059
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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