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

Cystic Fibrosis Clinical Trial

— MUCO-SOPHRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915875
• Other study ID #: P070706
• Secondary ID: 2008-A01575-50
• Status: Completed
• Phase: N/A
• First received: July 20, 2012
• Last updated: December 20, 2017
• Start date: February 15, 2012
• Est. completion date: November 19, 2014

Study information

• Verified date: December 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 19, 2014
• Est. primary completion date: November 19, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• sophrology sessions at home
The sophrology is a dynamic method of physical and psychical relaxation

Locations

Country	Name	City	State
France	hôpital Necker Enfants malades	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of maximum VAS	Change of maximum VAS for the site presenting a max VAS in the month following the inclusion.	6 months
Secondary	number of paroxystic episodes	Change of the number of paroxystic episodes	6 months
Secondary	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
Secondary	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
Secondary	BMI	improvement of the BMI,	6 months
Secondary	VEMS	improvement of the VEMS	6 months
Secondary	CVF	improvement of the CVF	6 months
Secondary	SaO2	improvement of the SaO2	6 months