hôpital Necker Enfants malades
Paris, 75015, France
NCT Number: NCT01915875
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.
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Notify Me10 year and older
All sexes
Interventional
Not applicable
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The sophrology is a dynamic method of physical and psychical relaxation
Time frame: 6 months
Change of maximum VAS for the site presenting a max VAS in the month following the inclusion.
Time frame: 6 months
Change of the number of paroxystic episodes
Time frame: 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)
Time frame: 6 months
Questionnaire of Quality of life CFQ 14 + and CHILD: physical functioning, vitality, body image and respiratory symptoms
Time frame: 6 months
improvement of the BMI,
Time frame: 6 months
improvement of the VEMS
Time frame: 6 months
improvement of the CVF
Time frame: 6 months
improvement of the SaO2
Assistance Publique - Hôpitaux de Paris
Other
Acronym: MUCO-SOPHRO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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