Observational Study of the Quality of Life for the Chronic Pain Patients Included in a Therapeutic Education Program Focused on Relaxation Techniques

NCT04536155 | Unknown

• 1 other identifier: CHMS19002
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The benefit of learning psychocorporal techniques in Therapeutic Education on the quality of life of patients with chronic pain will be studied. The purpose of this nursing research protocol is to highlight the improvement of the quality of life of chronic pain patients through psycho-physical techniques performed during group therapeutic education workshops.

Conditions

Chronic Pain

Keywords

visualization; abdominal respiration; synchronized breathing; Sophronisation; relaxation therapy; Do In self-massage; sophrology; breathing exercise; therapeutic education

Outcome Measures

Primary Outcomes (1)

• change of quality of life during the program

  SF36 score

  score at the end of the workshop compared to the score at the beginning

Secondary Outcomes (5)

• Change in quality of life

  Comparison between the beginning of the program and twelve months after the end of the program.

• Change in anxiety and depression

  Comparison at different moments in time - beginning, end, 6 months after, 12 months after

• Change in perceived pain

  Assessment at the beginning of the program and 12 months after the end using a numerical pain scale

• Evolution in patient's acceptance of chronic pain:after the end

  Comparison at different moments in time - beginning, end, 6 months after, 12 months after

• Change in physical activity

  Change in physical activity between the beginning of the program and 12 months after the end

Study Arms (1)

patient with chronic pain

Other: questionnary SF36; Other: Hospital Anxiety and Depression Scale; Other: Chronic Pain Acceptance Questionnaire; Other: digital pain scale

Interventions

questionnary SF36 OTHER

This is a validate questionnary: Ware et al,1992, McHorney et al, 1993, McHorney et al, 1994 French version : Author : Alain Leplège; et coll. En 2001

Also known as: 36 items Medical Outcome Study Short Form health survey

patient with chronic pain

Hospital Anxiety and Depression Scale OTHER

this is a validate scale: author: Zigmond A.S., Snaith R.P. in 1983

Also known as: HADS

patient with chronic pain

Chronic Pain Acceptance Questionnaire OTHER

This is a validate questionnaire: Fish, R., McGuire, B.E., Hogan, M., Stewart, I. \& Morrison, T. (2010).

Also known as: CPAQ

patient with chronic pain

digital pain scale OTHER

this is a validate scale A.N.A.E.S. February 1999

patient with chronic pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with chronic pain for whom a group "relaxation techniques" programm is planned and accepted by the patient.

You may qualify if:

• chronic pain since more the 3months
• Patients for whom a group "relaxation techniques" program is planned and accepted by the patient

You may not qualify if:

• Patient with progressive cancer pain
• severe psychiatric pathology (example: psychosis, deep melancholy)
• Patient not compliant or refusing to participate in research
• Person who does not understand French, or illiterate
• Person physically unable to complete questionnaires (visually impaired or blind)
• Person protected by sections L1121-5 to L1121-8.1 of the French Public Health Code

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead

Study Sites (1)

CH Metropole Savoie

Chambéry, 73011, France

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Valérie Roullot-Pradel

  CH Metropole Savoie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia TRIOLO

CONTACT

04.79.96.58.36; patricia.triolo@ch-metropole-savoie.fr

Valérie Roullot-Pradel

CONTACT

04.79.96.58.36; valerie.roullot.pradel@ch-metropole-savoie.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: September 2, 2020
• Study Start: January 2, 2020
• Primary Completion: October 2, 2022
• Study Completion: October 2, 2023
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)