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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sophrology sessions at home
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis focused on measuring Cystic fibrosis-pain-sophrology

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • hôpital Necker Enfants malades

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sophrology sessions

Arm Description

The sophrology is a dynamic method of physical and psychical relaxation

Outcomes

Primary Outcome Measures

Change of maximum VAS
Change of maximum VAS for the site presenting a max VAS in the month following the inclusion.

Secondary Outcome Measures

number of paroxystic episodes
Change of the number of paroxystic episodes
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)
Improvement of the quality of life
Questionnaire of Quality of life CFQ 14 + and CHILD: physical functioning, vitality, body image and respiratory symptoms
BMI
improvement of the BMI,
VEMS
improvement of the VEMS
CVF
improvement of the CVF
SaO2
improvement of the SaO2

Full Information

First Posted
July 20, 2012
Last Updated
December 20, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Fondation de France
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1. Study Identification

Unique Protocol Identification Number
NCT01915875
Brief Title
Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis
Acronym
MUCO-SOPHRO
Official Title
Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 15, 2012 (Actual)
Primary Completion Date
November 19, 2014 (Actual)
Study Completion Date
November 19, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Fondation de France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic fibrosis-pain-sophrology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sophrology sessions
Arm Type
Experimental
Arm Description
The sophrology is a dynamic method of physical and psychical relaxation
Intervention Type
Other
Intervention Name(s)
sophrology sessions at home
Intervention Description
The sophrology is a dynamic method of physical and psychical relaxation
Primary Outcome Measure Information:
Title
Change of maximum VAS
Description
Change of maximum VAS for the site presenting a max VAS in the month following the inclusion.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
number of paroxystic episodes
Description
Change of the number of paroxystic episodes
Time Frame
6 months
Title
intensity of maximum VAS of the painful episodes
Description
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
Title
Improvement of the quality of life
Description
Questionnaire of Quality of life CFQ 14 + and CHILD: physical functioning, vitality, body image and respiratory symptoms
Time Frame
6 months
Title
BMI
Description
improvement of the BMI,
Time Frame
6 months
Title
VEMS
Description
improvement of the VEMS
Time Frame
6 months
Title
CVF
Description
improvement of the CVF
Time Frame
6 months
Title
SaO2
Description
improvement of the SaO2
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Sermet, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
hôpital Necker Enfants malades
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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