Clinical trial NCT04063020: Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia
Official title: Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ear Aplasia
Keywords: Ear aplasia
Reconstructive plastic surgery
Subjective experience
Psychic stakes
Psychodynamic evaluation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minors with ear aplasia with or without articulatory disorders, without syndromic impairment and initiating a reconstructive plastic surgery procedure at Necker Hospital.

Brief 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hermann Rorschach test
timeFrame: 1 year
measure: Thematic Apperception Test
timeFrame: 1 year
measure: Inventory of Childhood Depression
timeFrame: 1 year
measure: KIDSCREEN-27
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Flora Aubertin, Psychologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Françoise Denoyelle, MD, PhD
role: STUDY_DIRECTOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Karinne Gueniche, Psychologist, Psychoanalyst
role: STUDY_DIRECTOR
References: