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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: questionnary SF36; Other: Hospital Anxiety and Depression Scale; Other: Chronic Pain Acceptance Questionnaire; Other: digital pain scale

Detailed Description

The study will be performed at Centre for the Study and Treatment of Pain. The patients with chronic pain will participate to a group programm of therapeutic education.

The programm consists of 9 workshops about psycho-corporal techniques performed in group.

The patients will complete questionnaries before beginning the program, at the end of the programm, 6 months after the end of the program, and 12 months after the end of program.

The questionnaries will be SF36, HADS, CPAQ, and digital pain scale.

• Study Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

• Study Contact: Name: Patricia TRIOLO; Phone Number: 33 04.79.96.58.36; Email: patricia.triolo@ch-metropole-savoie.fr
• Study Contact Backup: Name: Valérie Roullot-Pradel; Phone Number: 33 04.79.96.58.36; Email: valerie.roullot.pradel@ch-metropole-savoie.fr

Study Locations

• France
  • Chambéry, France, 73011
    • Recruiting
    • CH Métropole Savoie
    • Principal Investigator: Valérie Roullot-Pradel
    • Contact: Patricia Triolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patient with chronic pain

Other: questionnary SF36; 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; Other Names: 36 items Medical Outcome Study Short Form health survey; Other: Hospital Anxiety and Depression Scale; this is a validate scale: author: Zigmond A.S., Snaith R.P. in 1983; Other Names: HADS; Other: Chronic Pain Acceptance Questionnaire; This is a validate questionnaire: Fish, R., McGuire, B.E., Hogan, M., Stewart, I. & Morrison, T. (2010).; Other Names: CPAQ; Other: digital pain scale; this is a validate scale A.N.A.E.S. February 1999

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	assessed by sf36 score	Comparison between the beginning of the program and twelve months after the end of the program.
Change in anxiety and depression	assessed by HADS	Comparison at different moments in time - beginning, end, 6 months after, 12 months after
Change in perceived pain	assessed by numeric pain scale	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	assessed by Chronic Pain Acceptance Questionnaire	Comparison at different moments in time - beginning, end, 6 months after, 12 months after
Change in physical activity	assessed by SF36 Physical Activity Sub-Scale	Change in physical activity between the beginning of the program and 12 months after the end

Collaborators and Investigators

• Sponsor: Centre Hospitalier Metropole Savoie
• Investigators: Principal Investigator: Valérie Roullot-Pradel, CH Métropole Savoie

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Anticipated): October 2, 2022
• Study Completion (Anticipated): October 2, 2023

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: therapeutic education; breathing exercise; relaxation therapy; visualization; abdominal respiration; synchronized breathing; Sophronisation; Do In self-massage; sophrology
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CHMS19002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No