- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Provincie Groningen
-
Groningen, Provincie Groningen, Nederländerna, 9713 GZ
- University Medical Center Groningen
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Attending primary or secondary school
Exclusion Criteria:
-
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Children aged 6-17 years were eligible for participation.
Attending primary or secondary school
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Difference in social perception scores
Tidsram: The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Differences in social perception scores between primary and secondary school
Tidsram: 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.
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Myrthe KS Hol, Prof. dr., University Medical Center Groningen
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25059
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .