Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis (MUCO-SOPHRO)

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: sophrology sessions at home

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hopital Necker Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sophrology sessions; The sophrology is a dynamic method of physical and psychical relaxation	Other: sophrology sessions at home; The sophrology is a dynamic method of physical and psychical relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Fondation de France
• Investigators: Principal Investigator: Isabelle Sermet, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2012
• Primary Completion (Actual): November 19, 2014
• Study Completion (Actual): November 19, 2014

Study Registration Dates

• First Submitted: July 20, 2012
• First Submitted That Met QC Criteria: August 2, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Cystic fibrosis-pain-sophrology
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: P070706; 2008-A01575-50 (Other Identifier: EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No