Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia

NCT ID: NCT04063020

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-18

Study Completion Date

2022-12-23

Brief Summary

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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

Detailed Description

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Children with an ear aplasia have various cares (ENT, speech therapy, hearing aids and tomodensiometry) up to the proposal of the plastic reconstruction surgery at 9/10 years old.

The surgical technique used and preferred within Necker Hospital for these children is that of Saturo Nagata (1994).

This surgical protocol takes place in two times, spaced by 9 months. This surgery does not allow hearing better since it targets is only a reconstruction of the pinna. To date, no research has highlighted the subjective experience of a child with an aplasia of ear and of what this surgery engages and demands on the side of psychological work.

The purpose of this research is to interrogate the children's subjective experience with an unilateral ear aplasia and who wishes a plastic reconstruction surgery for their aplase ear.

Conditions

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Ear Aplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Reconstructive plastic surgery procedure

Minors with ear aplasia and initiating a reconstructive plastic surgery procedure

Psychological monitoring

Intervention Type BEHAVIORAL

Discussions with the psychologist PhD student before and after every surgery times : 3 discussions.

* Before the first surgery (about 1 month before) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)
* Before the second surgery (3 months later the first surgery) Clinical interview Drawing a person
* After the second surgery (15 months later the first surgery) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)

Interventions

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Psychological monitoring

Discussions with the psychologist PhD student before and after every surgery times : 3 discussions.

* Before the first surgery (about 1 month before) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)
* Before the second surgery (3 months later the first surgery) Clinical interview Drawing a person
* After the second surgery (15 months later the first surgery) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Flora Aubertin, Psychologist

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Françoise Denoyelle, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Karinne Gueniche, Psychologist, Psychoanalyst

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Necker-Enfants Malades

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2019-A00908-49

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190363

Identifier Type: -

Identifier Source: org_study_id

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