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Clinical Trials/NCT05666986
NCT05666986RecruitingNot Applicable

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 site in 1 country20 target enrollmentStarted: May 19, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Self-questionnaire (for the subjects)

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Self-questionnaire (for the subjects)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Secondary Outcomes

  • 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)

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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