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临床试验/NCT05666986
NCT05666986招募中不适用

Identification of Obstacles and Facilitators to the Engagement in Physical and Sports Activities in a Population of Adolescents Operated on for a Diaphragmatic Hernia

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Self-questionnaire (for the subjects)

研究概览

简要总结

The objective is to understand how a population of adolescents - who have undergone diaphragm surgery within their first month of life (i.e. subjects who have been carriers of a rare impacting disease such as congenital diaphragmatic hernia (CDH)) - engages in physical and sports activities and what can be the hindering factors as well as the factors facilitating these practices.

Based on self-questionnaires and semi-structured interviews, this research is a qualitative research in the field of human and social sciences.

The qualitative survey will make it possible to report on the experience of the disease of children and parents; in parallel, a complete medical evaluation of the subjects (clinical and para-clinical) will be carried out.

The analysis of the verbatim of the self-questionnaires and interviews with regard to the real physical capacities of the subjects, will be discussed.

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
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Child/adolescent having undergone surgery for CDH in the first month of life, aged 12 to 18 years; absence of polypathology (i.e. diaphragmatic hernia not associated with another pathology); follow-up at the CDH reference centre, Lille site
  • Written consent from both parents allowing the collection of data from the child/adolescent
  • Written consent from the parent(s) agreeing to participate in the study by answering the questionnaires and the individual interview, for themselves and for their child
  • Possibility of accessing equipment to conduct a video-conference interview if necessary.

排除标准

  • Parents or child/adolescent not understanding French
  • Parents under guardianship or child under legal protection

结局指标

主要结局

Self-questionnaire (for the subjects)

时间窗: At the time of inclusion

to collect the level of investment of the subject in their sport participation (from the subject's point of view)

Self-questionnaire (for the subject's parents)

时间窗: At the time of inclusion

to collect the subject's level of involvement in their sport (from the subject's parents' point of view

semi-directive interview of the subject's parents

时间窗: At the time of inclusion

allowing the identification of the dynamics of involvement in physical activities and sports practices, from the point of view of the subject's parents

semi-directive interview of the subject

时间窗: At the time of inclusion

allowing the identification of the dynamics of involvement in physical activities and sports practices, from the point of view of the subject (the adolescent)

次要结局

  • study of the diaphragmatic kinetics by cardiac MRI(At the time of inclusion)
  • Self-questionnaire and interviews (for the subjects)(At the time of inclusion)

研究者

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

研究点 (1)

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