Psychological Study in Children With Mucoviscidosis

Study Overview
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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.

Official Title
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Psychological Study of the Links Between Feeling and Fear of Pain, Anxiety and Quality of Life in Children With Mucoviscidosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with cystic fibrosis<br>Children over 8 and under 18 with cystic fibrosis. Children must be represented by their parent. | Other: Questionnaires<br>* The questionnaires focus on anxiety, fear and quality of life.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Links between pain during care and anxiety | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Links between pain-related fears and pain during care | 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. | 1 day | 
| Links between pain during care and quality of life | 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. | 1 day | 
| Links between pain during care and the severity of the disease | 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. | 1 day | 
| Links between the severity of the disease and anxiety | 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. | 1 day | 
| Links between parents' anxiety and the child's anxiety | 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Children, Pain, Anxiety