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

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: sophrology sessions at home

• Registration Number: NCT01915875
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2012-02-15
• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2013-08-02
• Study First Posted: 2013-08-05
• Primary Completion: 2014-11-19
• Study Completion: 2014-11-19
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sophrology sessions	sophrology sessions at home	The sophrology is a dynamic method of physical and psychical relaxation

Primary Outcome Measures

Name	Time	Method
Change of maximum VAS	6 months	Change of maximum VAS for the site presenting a max VAS in the month following the inclusion.

Secondary Outcome Measures

Name	Time	Method
VEMS	6 months	improvement of the VEMS
SaO2	6 months	improvement of the SaO2
number of paroxystic episodes	6 months	Change of the number of paroxystic episodes
CVF	6 months	improvement of the CVF
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
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)
BMI	6 months	improvement of the BMI,

Trial Locations

Locations (1)

hôpital Necker Enfants malades; 🇫🇷 Paris, France