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Completed

NCT Number: NCT01915875

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

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

hôpital Necker Enfants malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sophrology sessions at home

Other

The sophrology is a dynamic method of physical and psychical relaxation

Primary outcomes

  1. 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.

Secondary outcomes

  1. number of paroxystic episodes

    Time frame: 6 months

    Change of the number of paroxystic episodes

  2. intensity of maximum VAS of the painful episodes

    Time frame: 6 months

    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)

  3. Improvement of the quality of life

    Time frame: 6 months

    Questionnaire of Quality of life CFQ 14 + and CHILD: physical functioning, vitality, body image and respiratory symptoms

  4. BMI

    Time frame: 6 months

    improvement of the BMI,

  5. VEMS

    Time frame: 6 months

    improvement of the VEMS

  6. CVF

    Time frame: 6 months

    improvement of the CVF

  7. SaO2

    Time frame: 6 months

    improvement of the SaO2

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fondation de France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: MUCO-SOPHRO

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2013
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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