NCT07721805

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

July 13, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

Social perceptionPeer perceptionMicrotiaAuricular reconstruction

Outcome Measures

Primary Outcomes (1)

  • Difference in social perception scores

    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.

Secondary Outcomes (1)

  • Differences in social perception scores between primary and secondary school

    The entire assessment can be completed directly after enrollment and takes a maximum of 5 minutes.

Study Arms (1)

Children aged 6-17 years were eligible for participation.

Attending primary or secondary school

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children aged 6-17 years attending primary or secondary schools were eligible for participation

You may qualify if:

  • Attending primary or secondary school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Congenital Microtia

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Myrthe KS Hol, Prof. dr.

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2026

First Posted

July 23, 2026

Study Start

March 4, 2026

Primary Completion

June 22, 2026

Study Completion

June 22, 2026

Last Updated

July 23, 2026

Record last verified: 2025-06

Locations