Cystic Fibrosis
Conditions
Keywords
Cystic fibrosis-pain-sophrology
Brief summary
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
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.
Interventions
OTHERsophrology sessions at home
The sophrology is a dynamic method of physical and psychical relaxation
Sponsors
Fondation de France
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of maximum VAS | 6 months | Change of maximum VAS for the site presenting a max VAS in the month following the inclusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intensity of maximum VAS of the painful episodes | 6 months | 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) |
| Improvement of the quality of life | 6 months | Questionnaire of Quality of life CFQ 14 + and CHILD: physical functioning, vitality, body image and respiratory symptoms |
| BMI | 6 months | improvement of the BMI, |
| number of paroxystic episodes | 6 months | Change of the number of paroxystic episodes |
| CVF | 6 months | improvement of the CVF |
| SaO2 | 6 months | improvement of the SaO2 |
| VEMS | 6 months | improvement of the VEMS |
Countries
France
Outcome results
None listed