Craniosynostosis: How to Improve the Diagnosis and Assist Patients and Their Families?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 574
- 试验地点
- 1
- 主要终点
- measure by questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)
研究概览
简要总结
The purposes of this study are:
- to better understand the experience of the announcement for the diagnostic of craniosynostosis to patients and their families to improve the understanding of it and it modes of appropriation
- to compare the announcement process concerning "simple" and "complex" forms.
- to identify the intra-family issues at the announcement of a genetic mutation.
- to reconstruct the care course of patients by analyzing the time of the announcement and the post-operative period.
详细描述
The supported hypothesis is that the diagnosis of craniosynostosis disturbs the initial family pattern. The different forms of the disease will have different repercussions on intra-family relationships.
The quality of the announcement done by the doctor influences the way how the subjects (parents and patients themselves) appropriate and incorporate it at short, medium and long term.
This research will contribute to the knowledge of this rare disease by different scientific communities: social sciences, medicine and neuropsychology. The originality of this research lies in interdisciplinary teams involved and the cross looks between professional and associative fields.
To better understand the impact of congenital malformations and specifically those related to craniosynostosis, the experiences of children and their families at short, medium and long term, the research will take place in the center of reference "Dysostoses craniofacial", Pediatric Neurosurgery Service at the Necker Hospital in Paris.
Prior to fieldwork, a thorough literature search will be conducted on issues related to our subject: the announcement, psychological, identity, family and social impacts, as well as the specifics of the disease and its manifestations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents of operated children with a clinical diagnosis of craniosynostosis
- •Parents of newly diagnosed children for a craniosynostosis who will be operated
- •Children aged 15 who were operated for a craniosynostosis at least 10 years ago
- •Parents of newly diagnosed children for a craniosynostosis who will be operated
- •Children aged 15 who were operated for a craniosynostosis at least 10 years ago
排除标准
- •nothing to declare
研究组 & 干预措施
quantitative survey 1
parents of 300 patients with craniosynostosis diagnostic
干预措施: quantitative survey (Other)
quantitative survey 2
- 100 parents of patients 1 year after surgery
- 100 parents of patients, 5 years after the operation
- 100 patients aged over 15 years and operated over 10 years ago
干预措施: quantitative survey (Other)
qualitative survey
- parents of 12 newly diagnosed patients, they will be seen 3 times (after the diagnosis, 3 months after surgery, 1 year after surgery
- 12 patients aged over 15 years, operated more than 10 years before
干预措施: qualitative survey (Other)
结局指标
主要结局
measure by questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)
时间窗: 5 months
Analysis of the questionnaires will permit us to learn more about the conditions and experiences of the announcement concerning different profiles families whose experience has been received differently depending on the type of craniosynostosis (simple or complex), the medical history or sociodemographic characteristics.
次要结局
- measure by interview the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) interview(16 months)
- measure by an other questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)(6 months)