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

NCT ID: NCT01915875

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-15

Study Completion Date

2014-11-19

Brief Summary

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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

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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

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Cystic Fibrosis

Keywords

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Cystic fibrosis-pain-sophrology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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sophrology sessions

The sophrology is a dynamic method of physical and psychical relaxation

Group Type EXPERIMENTAL

sophrology sessions at home

Intervention Type OTHER

The sophrology is a dynamic method of physical and psychical relaxation

Interventions

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sophrology sessions at home

The sophrology is a dynamic method of physical and psychical relaxation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation de France

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle Sermet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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hôpital Necker Enfants malades

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2008-A01575-50

Identifier Type: OTHER

Identifier Source: secondary_id

P070706

Identifier Type: -

Identifier Source: org_study_id