CompletedNot Applicable

Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia

France12 participantsStarted 2020-01-18

Plain-language summary

The objective of the study is to analyse : * Psychic experience of ear aplasia in children ; * the modalities of their psychic functioning ; * and the psychological repercussions of the plastic reconstruction surgery

Who can participate

Age range

10 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Minors of 10 to 16 years old * Unilateral ear aplasia with or without articulatory disorders, followed and engaged in reconstruction surgery procedure within the ENT service of cervico-facial surgery of the Necker Hospital * Children wishing a plastic reconstruction surgery and having received the approval of the medical team * Francophone children * Holders of parental authority and child voluntary for the research Exclusion Criteria: * Illiterate children * Severe intellectual deficit * Bilateral aplasia * Syndromic impairment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hermann Rorschach test

Timeframe: 1 year

Thematic Apperception Test

Timeframe: 1 year

Inventory of Childhood Depression

Timeframe: 1 year

KIDSCREEN-27

Timeframe: 1 year

Trial details

NCT IDNCT04063020

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-23

View on ClinicalTrials.gov More Ear Aplasia trials

Who can participate

Age range

10 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.