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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Cystic Fibrosis

Treatments

Other: sophrology sessions at home

Study type

Interventional

Funder types

Other

Identifiers

NCT01915875
P070706
2008-A01575-50 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

10+ years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

sophrology sessions
Experimental group
Description:
The sophrology is a dynamic method of physical and psychical relaxation
Treatment:
Other: sophrology sessions at home

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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