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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-A01575-50 | Other Identifier | EudraCT Number |
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| Name | Class |
|---|---|
| Fondation de France | OTHER |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sophrology sessions | Experimental | The sophrology is a dynamic method of physical and psychical relaxation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sophrology sessions at home | Other | The sophrology is a dynamic method of physical and psychical relaxation |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Sermet, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hôpital Necker Enfants malades | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |