Psychological Study in Children With Mucoviscidosis

NCT ID: NCT05948488

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-28

Study Completion Date

2022-08-28

Brief Summary

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Cystic fibrosis is the most common serious genetic disease in Europe. It is a multi-disciplinary disease, causing multiple organ damage. It is a painful disease and a source of anxiety and depression.

The aim of this study is to assess the link between pain experienced during care and anxiety in children aged over 8 with cystic fibrosis.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with cystic fibrosis

Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent.

Questionnaires

Intervention Type OTHER

The questionnaires focus on anxiety, fear and quality of life.

Interventions

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Questionnaires

The questionnaires focus on anxiety, fear and quality of life.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have cystic fibrosis
* Child aged over 8 years and under 18 years
* Presence of at least one parent at the time of inclusion
* To be present for a scheduled hospitalisation at the Resources and Competence Centres for Cystic Fibrosis
* Do not object to the research

Exclusion Criteria

* Under 8 or over 18 years of age
* Lack of at least one parent at the time of inclusion
* Presence of chronic co-morbidities
* Difficulty reading and understanding French
* Objection to taking part in research
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Géraldine LABOURET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Géraldine LABOURET

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2018-A02216-49

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/18/0304

Identifier Type: -

Identifier Source: org_study_id

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