Completed

NCT Number: NCT04063020

Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia

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

Completed

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Key information

Conditions

Ear Aplasia

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychological monitoring

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)

Primary outcomes

Hermann Rorschach test

Time frame: 1 year

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.
Thematic Apperception Test

Time frame: 1 year
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.
Inventory of Childhood Depression

Time frame: 1 year

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.
KIDSCREEN-27

Time frame: 1 year
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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: EPCHIRPRORL

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Aug 20, 2019
Registry last updated: Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.