Psychological Study in Children With Mucoviscidosis

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: Questionnaires

• Registration Number: NCT05948488
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

Not available

Study Timeline

• Study Start: 2019-02-28
• Primary Completion: 2022-08-28
• Study Completion: 2022-08-28
• Status Verified: 2023-07
• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-05
• Last Update Submitted: 2023-07-05
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Links between pain during care and anxiety	1 day	Pain during care is assessed using the Visual Analogic Scale (VAS) and anxiety using the State Trait Anxiety Inventory (STAI) scale.; The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".; The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.

Secondary Outcome Measures

Name	Time	Method
Links between pain during care and the severity of the disease	1 day	Pain during care is assessed using the Visual Analogic Scale (VAS) and the severity of the disease by the number of respiratory exacerbations per year.; The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".
Links between the severity of the disease and anxiety	1 day	Anxiety is assessed using tthe State Trait Anxiety Inventory (STAI) scale and the severity of the disease by the number of respiratory exacerbations per year.; The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.
Links between pain-related fears and pain during care	1 day	Pain related fears is assessed using the Fear of Pain Questionnaire (FOPQ) and pain during care using the Visual Analogic Scale (VAS).; The Fear of Pain Questionnaire (FOPQ) is a self-assessment scale. It consists of 24 items. For item, there are five modalities : strongly disagree, disagree, don't know, agree, strongly agree.; The Visual Analogic Scale (VAS) is a self-assessment scale. It takes the form of a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".
Links between pain during care and quality of life	1 day	Pain during care is assessed using the Visual Analogic Scale (VAS) and quality of life using the Cystic Fibrosis Questionnaire (CFQ).; The Visual Analogic Scale (VAS) is a self-assessment scale. It is a line. At one end is indicated: 0 "no pain", at the other: 100 "unbearable pain".; The Cystic Fibrosis Questionnaire (CFQ) composed of four modalities : always, often, sometime, never.
Links between parents' anxiety and the child's anxiety	1 day	Parent's anxiety and child's anxiety is assessed using tthe State Trait Anxiety Inventory (STAI) scale.; The State Trait Anxiety Inventory (STAI) is a self-assessment scale. It consists of 20 items. For item, the child has to choose one of three modalities : almost never, sometimes, often. The higher the score, the more severe the anxiety.; The scale is suitable for parents and children.

Trial Locations

Locations (1)

Géraldine LABOURET; 🇫🇷 Toulouse, France