Engagement in Physical Activities and Sports in Adolescents With Diaphragmatic Hernia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Congenital Diaphragmatic Hernia. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identification of Obstacles and Facilitators to the Engagement in Physical and Sports Activities in a Population of Adolescents Operated on for a Diaphragmatic Hernia
Overview
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.
Primary outcome measures
- Self-questionnaire (for the subjects) [Time frame: At the time of inclusion]
- Self-questionnaire (for the subject's parents) [Time frame: At the time of inclusion]
- semi-directive interview of the subject [Time frame: At the time of inclusion]
- semi-directive interview of the subject's parents [Time frame: At the time of inclusion]
Secondary outcome measures (2)
- study of the diaphragmatic kinetics by cardiac MRI [Time frame: At the time of inclusion]
- Self-questionnaire and interviews (for the subjects) [Time frame: At the time of inclusion]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Parents or child/adolescent not understanding French
- Parents under guardianship or child under legal protection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- chu de Lille — Lille
Identifiers
NCT: NCT05666986 · 2021_0342 · 2021-A02518-33