Cystic FibrosisMUCO-SOPHRONCT01915875
Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis
A study testing sophrology sessions at home in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- sophrology sessions at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2012to 19 Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- sophrology sessions at home
- Keywords
- Cystic fibrosis-pain-sophrology
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sophrology sessions at homeOther
The sophrology is a dynamic method of physical and psychical relaxation
| Study group | Role | What they receive |
|---|---|---|
| sophrology sessions | Experimental | The sophrology is a dynamic method of physical and psychical relaxation Receives: Other: sophrology sessions at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of maximum VAS
Change of maximum VAS for the site presenting a max VAS in the month following the inclusion.
Measured: 6 months
Secondary outcomes (7)
number of paroxystic episodes
Change of the number of paroxystic episodes
Measured: 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)
Measured: 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
Measured: 6 months
BMI
improvement of the BMI,
Measured: 6 months
VEMS
improvement of the VEMS
Measured: 6 months
CVF
improvement of the CVF
Measured: 6 months
SaO2
improvement of the SaO2
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study start15 Feb 2012
- Primary completion19 Nov 2014
- Study completion19 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Isabelle Sermet, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915875
- Sponsor's protocol ID
- P070706
- Other IDs
- 2008-A01575-50
- Acronym
- MUCO-SOPHRO
- Status last verified
- Oct 2025
- First submitted
- 20 Jul 2012
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Global Care of the Pain at Chronic Painful Patients Affected by Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01915875
- Acronym / sponsor ID
- MUCO-SOPHRO / P070706
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis-pain-sophrology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation de France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Feb 2012 (actual)
- Primary completion
- 19 Nov 2014 (actual)
- Study completion
- 19 Nov 2014 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sophrology sessions | Experimental | Other: sophrology sessions at homeThe sophrology is a dynamic method of physical and psychical relaxation |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sophrology sessions at homeThe sophrology is a dynamic method of physical and psychical relaxation | Other | sophrology sessions |
Primary outcome
Change of maximum VAS
Time frame: 6 months
Change of maximum VAS for the site presenting a max VAS in the month following the inclusion.
7 secondary outcomes
number of paroxystic episodes
Time frame: 6 months
intensity of maximum VAS of the painful episodes
Time frame: 6 months
Improvement of the quality of life
Time frame: 6 months
BMI
Time frame: 6 months
VEMS
Time frame: 6 months
CVF
Time frame: 6 months
SaO2
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Sermet, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sophrology sessions at home in people with Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of maximum VAS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.