Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia (EPCHIRPRORL)

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

Study Overview

• Status: Completed
• Conditions: Ear Aplasia
• Intervention / Treatment: Behavioral: Psychological monitoring

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Reconstructive plastic surgery procedure; Minors with ear aplasia and initiating a reconstructive plastic surgery procedure

Behavioral: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hermann Rorschach test	Hermann Rorschach test (1927) Test or projected test composed of 10 boards. Analysis by the psychogram (following the Chabert method). Psychic functioning of the child by description of: the mechanisms of defenses, the type of anxiety, the affective tone and the image of the body. The capacity to give adapted responses according to the boards as well as the narrative capacity of the child will make it possible to release tracks as for its psychic functioning.	1 year
Thematic Apperception Test	TAT: Thematic Apperception Test by MURRAY H.A. (1935) Projective test where the boards are different from the sex of the child (boy 13 boards, girls 14 boards). Quantitative analysis using the 4-dimensional tabulation sheet : Series A: Rigidity; Series B: Lability; Series C: Conflict Avoidance; Series E: Emergencies of Primary Processes Psychic functioning of the child by description of: the mechanisms of defenses, the type of anxiety, the affective tone and the image of the body. The capacity to give adapted responses according to the boards as well as the narrative capacity of the child will make it possible to release tracks as for its psychic functioning.	1 year
Inventory of Childhood Depression	CDI: Inventory of Childhood Depression by M. Kovcas & A.T. Beck (1977) L.MOOR and C.MACK. Scale from 7 to 17 years. The score ranges from 0 to 54. The scale of rating goes from 0 to 2 with an alternation in the quotation of the articles so that the subject is not influenced by a same scheme of proposal by item. A score greater than or equal to 15 would be synonymous with depression but confirmed in clinical interview.	1 year
KIDSCREEN-27	KIDSCREEN-27 from Kidscreen group europe (2006) -42 authors in all- The KIDSCREEN-27 is scored on a 5 point scale (1 = not at all, 2 = a little, 3 = moderately, 4 = a lot, 5 = extremely). Assessement of quality of life in children. The score can be calculated for each dimension: Physical activities and health - 5 items;; The mood in general and the feeling - 7 elements;; Family life and free time - 7 articles;; Friends (social support and peers) - 4 elements;; At school (School Environment) - 4 elements.	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Flora Aubertin, Psychologist, Assistance Publique - Hôpitaux de Paris; Study Director: Françoise Denoyelle, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: Karinne Gueniche, Psychologist, Psychoanalyst, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2020
• Primary Completion (Actual): December 23, 2022
• Study Completion (Actual): December 23, 2022

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Ear aplasia; Reconstructive plastic surgery; Subjective experience; Psychic stakes; Psychodynamic evaluation
• Other Study ID Numbers: APHP190363; 2019-A00908-49 (Other Identifier: IDRCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No