Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis
MUCO-SOPHRO
2 other identifiers
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2012
CompletedFirst Submitted
Initial submission to the registry
July 20, 2012
CompletedFirst Posted
Study publicly available on registry
August 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2014
CompletedNovember 20, 2025
October 1, 2025
2.8 years
July 20, 2012
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of maximum VAS
Change of maximum VAS for the site presenting a max VAS in the month following the inclusion.
6 months
Secondary Outcomes (7)
number of paroxystic episodes
6 months
intensity of maximum VAS of the painful episodes
6 months
Improvement of the quality of life
6 months
BMI
6 months
VEMS
6 months
- +2 more secondary outcomes
Study Arms (1)
sophrology sessions
EXPERIMENTALThe sophrology is a dynamic method of physical and psychical relaxation
Interventions
The sophrology is a dynamic method of physical and psychical relaxation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Fondation de Francecollaborator
- URC-CIC Paris Descartes Necker Cochincollaborator
Study Sites (1)
hôpital Necker Enfants malades
Paris, 75015, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle Sermet, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2012
First Posted
August 5, 2013
Study Start
February 15, 2012
Primary Completion
November 19, 2014
Study Completion
November 19, 2014
Last Updated
November 20, 2025
Record last verified: 2025-10