- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Provincie Groningen
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Groningen, Provincie Groningen, Netherlands, 9713 GZ
- University Medical Center Groningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Attending primary or secondary school
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Children aged 6-17 years were eligible for participation.
Attending primary or secondary school
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Difference in social perception scores
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in social perception scores between primary and secondary school
Time Frame: 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.
|
The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Myrthe KS Hol, Prof. dr., University Medical Center Groningen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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