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

N/ACompletedNCT01915875

Assistance Publique - Hôpitaux de Paris13 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

sophrology sessions at homeOTHER

The sophrology is a dynamic method of physical and psychical relaxation

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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.

Locations (1)

hôpital Necker Enfants malades

Paris, France

Outcomes

Primary Outcomes

Change of maximum VAS

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

Time frame: 6 months

Secondary Outcomes

number of paroxystic episodes

Change of the number of paroxystic episodes

Time frame: 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)

Time frame: 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

Time frame: 6 months

BMI

improvement of the BMI,

Time frame: 6 months

VEMS

improvement of the VEMS

Time frame: 6 months

CVF

improvement of the CVF

Time frame: 6 months

SaO2

improvement of the SaO2

Time frame: 6 months

Data from ClinicalTrials.gov

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