Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of the global approach to the pain in cystic fibrosis patients with chronic or intermittent pain. The patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The results of this study will provide a new strategy of management of the patient's pain.

Detailed Description
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The majority of cystic fibrosis patients have chronic or intermittent pains. These pains have important consequences on the quality of life. Currently, the treatment is essentially pharmacological (essentially paracetamol) but it is not enough in presence of of visual analogue scale (VAS) >4. In the study, the patients will receive in addition to an usual pharmacological and psychological management, sophrology sessions at home. The sophrology is a dynamic method of physical and psychical relaxation. This aims are to decrease the pain, to decrease the anxiety and to improve the everyday life. This study will provide a new global strategy of the management of the patients' pain.

Official Title
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Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Other: sophrology sessions at home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cystic fibrosis patients defined by a test sweat and / or 2 pathogenic mutations Patients over 10 years Patients with pain symptoms (VAS> 4) recurrent (> 4 episodes / month) or permanent since more than 6 months Agreement of patients, and parents (for children) for sophrology sessions conducted at home. Patient affiliated to social security Exclusion Criteria: Transplant patients or placed on a waiting list transplantation Patients had a patient-support by techniques hypnosis or relaxation therapy, during or within 3 months. Patients enrolled in another research interventional protocol. Women without contraception or pregnant.

Ages Eligible for Study
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Minimum Age: 10 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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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sophrology sessions<br>The sophrology is a dynamic method of physical and psychical relaxation | Other: sophrology sessions at home<br>* The sophrology is a dynamic method of physical and psychical relaxation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of maximum VAS | Change of maximum VAS for the site presenting a max VAS in the month following the inclusion. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of paroxystic episodes | Change of the number of paroxystic episodes | 6 months | 
| intensity of maximum VAS of the painful episodes | Change of the intensity of maximum VAS of the painful episodes between the month following the inclusion and last month of the study (for all the sites) | 6 months | 
| Improvement of the quality of life | Questionnaire of Quality of life CFQ 14 + and CHILD: physical functioning, vitality, body image and respiratory symptoms | 6 months | 
| BMI | improvement of the BMI, | 6 months | 
| VEMS | improvement of the VEMS | 6 months | 
| CVF | improvement of the CVF | 6 months | 
| SaO2 | improvement of the SaO2 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic fibrosis-pain-sophrology