Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia
NCT ID: NCT04063020
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
12 participants
OBSERVATIONAL
2020-01-18
2022-12-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* Psychic experience of ear aplasia in children ;
* the modalities of their psychic functioning ;
* and the psychological repercussions of the plastic reconstruction surgery
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fundamental and Clinical Study of Cochlear Synaptopathy
NCT06556160
Study of Gesture and Executive Functions in Children With High Intellectual Potential
NCT03128125
Dual Tasking in Children With Cerebral Palsy and Healthy Children: an EEG Study
NCT04634292
Motor Deficits and Signal Conduction in Individuals With Williams Syndrome
NCT05430763
Measurement of the Prevalence of Sensory Integration Disorders in Babies Having Heart Disease Surgery for Transposition of the Great Vessels Before 6 Months of Age
NCT05137873
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Reconstructive plastic surgery procedure
Minors with ear aplasia and initiating a reconstructive plastic surgery procedure
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Severe intellectual deficit
* Bilateral aplasia
* Syndromic impairment
10 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Necker-Enfants Malades
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-A00908-49
Identifier Type: OTHER
Identifier Source: secondary_id
APHP190363
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.