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临床试验/NCT00993993
NCT00993993已完成不适用

Relational Development in Children With Cleft Lips and Palates: Influence of the Waiting Period Prior to the First Surgical Intervention and the Parents' Psychological Perception of the Abnormality

University Hospital, Strasbourg, France6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年4月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
6
主要终点
Assess the emotional state of withdrawal of any child carrying a CL/P based on the psychological state of their parents and time before the first surgery. We use ADBB scale for the child.

研究概览

简要总结

The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P) is multidisciplinary. The careful consideration of concerned families during the repetitive appointments required by these treatments show the importance of the psychological context and of the harmonious structuring of the parents-child relationships on the child's development. Yet the birth of a child affected by CL/P is a particularly stressing and traumatising event for the parents. The investigators' prospective, multidisciplinary and multi-centred research project aims to assess the psychological perceptions of parents of children affected by CL/P over the year following the birth and analyse the child's degree of psychological suffering as well as the parents-child relationships. The time of the first surgical intervention varies amongst the treatment centres. The investigators listed four centres that intervene at different times according to the more or less long waiting times between the child's birth and this first surgical intervention. The results obtained for each group will be compared to one another and according to two sub-groups: parents who found out about the CL/P through embryo diagnosis and those who found out at their child's birth. The mental and psychological dimension due to the malformation and its correction will be analysed in the parents group (importance of the prenatal diagnosis, relational development with the child, self-esteem, quality of life) but also in the child (likely distress and withdrawal symptoms).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
4 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children with Cleft Lip with or without Cleft Palate and their Parents

排除标准

  • Children with Cleft Palate without Cleft Lip
  • Children born the 35th week of d'amenorrhea
  • Children with a birth weight inferior to 1800 g
  • Children put under care by court order
  • Parents under administrative supervision
  • Parents who are not familiar with the french language and/or illiterate

结局指标

主要结局

Assess the emotional state of withdrawal of any child carrying a CL/P based on the psychological state of their parents and time before the first surgery. We use ADBB scale for the child.

时间窗: 2 years

Learning about the psychological effects of this abnormality on parents from the time of diagnosis and of the therapeutic management. We use PSI scale for the parents.

时间窗: 2 years

次要结局

  • Indices of psychological distress by Quebec Health Survey (IDPESQ) and the Edinburgh Postnatal Depression Scale (EPDS).The Family Impact Scale. The Dyadic Adjustment Scale Spanier of determining the marital context and questionnaires ad-hoc.(2 years)

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (6)

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