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临床试验/NCT04063020
NCT04063020已完成不适用

Psychic Stakes of Reconstructive Plastic Surgery in Children With Ear Aplasia

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Hermann Rorschach test

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Illiterate children
  • Severe intellectual deficit
  • Bilateral aplasia
  • Syndromic impairment

结局指标

主要结局

Hermann Rorschach test

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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