- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Provincie Groningen
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Groningen, Provincie Groningen, Nederland, 9713 GZ
- University Medical Center Groningen
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Attending primary or secondary school
Exclusion Criteria:
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Children aged 6-17 years were eligible for participation.
Attending primary or secondary school
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in social perception scores
Tidsramme: 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.
|
The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Differences in social perception scores between primary and secondary school
Tidsramme: The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.
|
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.
|
The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Myrthe KS Hol, Prof. dr., University Medical Center Groningen
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 25059
Plan for individuelle deltakerdata (IPD)
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