Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT04063020
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2019-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-08-19', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hermann Rorschach test', 'timeFrame': '1 year', 'description': 'Hermann Rorschach test (1927) Test or projected test composed of 10 boards. Analysis by the psychogram (following the Chabert method).\n\nPsychic 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.'}, {'measure': 'Thematic Apperception Test', 'timeFrame': '1 year', 'description': '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).\n\nQuantitative analysis using the 4-dimensional tabulation sheet :\n\n* Series A: Rigidity\n* Series B: Lability\n* Series C: Conflict Avoidance\n* Series E: Emergencies of Primary Processes\n\nPsychic 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.'}, {'measure': 'Inventory of Childhood Depression', 'timeFrame': '1 year', 'description': 'CDI: Inventory of Childhood Depression by M. Kovcas \\& A.T. Beck (1977) L.MOOR and C.MACK.\n\nScale 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.\n\nA score greater than or equal to 15 would be synonymous with depression but confirmed in clinical interview.'}, {'measure': 'KIDSCREEN-27', 'timeFrame': '1 year', 'description': '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).\n\nAssessement of quality of life in children.\n\nThe score can be calculated for each dimension:\n\n* Physical activities and health - 5 items;\n* The mood in general and the feeling - 7 elements;\n* Family life and free time - 7 articles;\n* Friends (social support and peers) - 4 elements;\n* At school (School Environment) - 4 elements.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ear aplasia', 'Reconstructive plastic surgery', 'Subjective experience', 'Psychic stakes', 'Psychodynamic evaluation'], 'conditions': ['Ear Aplasia']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to analyse :\n\n* Psychic experience of ear aplasia in children ;\n* the modalities of their psychic functioning ;\n* and the psychological repercussions of the plastic reconstruction surgery', 'detailedDescription': "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.\n\nThe surgical technique used and preferred within Necker Hospital for these children is that of Saturo Nagata (1994).\n\nThis 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Minors with ear aplasia with or without articulatory disorders, without syndromic impairment and initiating a reconstructive plastic surgery procedure at Necker Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minors of 10 to 16 years old\n* 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\n* Children wishing a plastic reconstruction surgery and having received the approval of the medical team\n* Francophone children\n* Holders of parental authority and child voluntary for the research\n\nExclusion Criteria:\n\n* Illiterate children\n* Severe intellectual deficit\n* Bilateral aplasia\n* Syndromic impairment'}, 'identificationModule': {'nctId': 'NCT04063020', 'acronym': 'EPCHIRPRORL', 'briefTitle': 'Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia', 'orgStudyIdInfo': {'id': 'APHP190363'}, 'secondaryIdInfos': [{'id': '2019-A00908-49', 'type': 'OTHER', 'domain': 'IDRCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Reconstructive plastic surgery procedure', 'description': 'Minors with ear aplasia and initiating a reconstructive plastic surgery procedure', 'interventionNames': ['Behavioral: Psychological monitoring']}], 'interventions': [{'name': 'Psychological monitoring', 'type': 'BEHAVIORAL', 'description': "Discussions with the psychologist PhD student before and after every surgery times : 3 discussions.\n\n* 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)\n* Before the second surgery (3 months later the first surgery) Clinical interview Drawing a person\n* 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)", 'armGroupLabels': ['Reconstructive plastic surgery procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'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', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}