Ear AplasiaEPCHIRPRORLNCT04063020
Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia
An observational study of Ear Aplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Ear Aplasia
- What is being tested?
- Psychological monitoring
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2020to 23 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Minors with ear aplasia with or without articulatory disorders, without syndromic impairment and initiating a reconstructive plastic surgery procedure at Necker Hospital.
Who may be able to join
- 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
Who cannot join
- Illiterate children
- Severe intellectual deficit
- Bilateral aplasia
- Syndromic impairment
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Ear Aplasia
- Being tested
- Psychological monitoring
- Keywords
- Ear aplasia, Reconstructive plastic surgery, Subjective experience, Psychic stakes, Psychodynamic evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological monitoringBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Reconstructive plastic surgery procedure | Minors with ear aplasia and initiating a reconstructive plastic surgery procedure Receives: Behavioral: Psychological monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start18 Jan 2020
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear AplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Flora Aubertin, Psychologist, Principal investigator, Assistance Publique - Hôpitaux de ParisFrançoise Denoyelle, MD, PhD, Study director, Assistance Publique - Hôpitaux de ParisKarinne Gueniche, Psychologist, Psychoanalyst, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063020
- Sponsor's protocol ID
- APHP190363
- Other IDs
- 2019-A00908-49
- Acronym
- EPCHIRPRORL
- Status last verified
- Mar 2026
- First submitted
- 4 Jun 2019
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia
- ClinicalTrials.gov ID
- NCT04063020
- Acronym / sponsor ID
- EPCHIRPRORL / APHP190363
- Conditions
- Ear Aplasia
- Keywords
- Ear aplasia, Reconstructive plastic surgery, Subjective experience, Psychic stakes, Psychodynamic evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 18 Jan 2020 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reconstructive plastic surgery procedure | – | Behavioral: Psychological monitoringMinors with ear aplasia and initiating a reconstructive plastic surgery procedure |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Minors with ear aplasia with or without articulatory disorders, without syndromic impairment and initiating a reconstructive plastic surgery procedure at Necker Hospital.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Illiterate children
- Severe intellectual deficit
- Bilateral aplasia
- Syndromic impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological monitoringDiscussions 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) | Behavioural | Reconstructive plastic surgery procedure |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flora Aubertin, Psychologist principal investigator
Assistance Publique - Hôpitaux de Paris
Françoise Denoyelle, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
Karinne Gueniche, Psychologist, Psychoanalyst study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ear Aplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hermann Rorschach test (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.