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

Sponsor
Centre Hospitalier Metropole Savoie (Other)
Overall Status
Recruiting
CT.gov ID
NCT04536155
Collaborator
(none)
72
1
45
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
72 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Study of the Quality of Life for the Chronic Pain Patients Included in a Therapeutic Education Program Focused on Relaxation Techniques
Actual Study Start Date :
Jan 2, 2020
Anticipated Primary Completion Date :
Oct 2, 2022
Anticipated Study Completion Date :
Oct 2, 2023

Arms and Interventions

Arm 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

    Outcome Measures

    Primary Outcome Measures

    1. change of quality of life during the program [score at the end of the workshop compared to the score at the beginning]

      SF36 score

    Secondary Outcome Measures

    1. Change in quality of life [Comparison between the beginning of the program and twelve months after the end of the program.]

      assessed by sf36 score

    2. Change in anxiety and depression [Comparison at different moments in time - beginning, end, 6 months after, 12 months after]

      assessed by HADS

    3. Change in perceived pain [Assessment at the beginning of the program and 12 months after the end using a numerical pain scale]

      assessed by numeric pain scale

    4. 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]

      assessed by Chronic Pain Acceptance Questionnaire

    5. Change in physical activity [Change in physical activity between the beginning of the program and 12 months after the end]

      assessed by SF36 Physical Activity Sub-Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CH Metropole Savoie Chambéry France 73011

    Sponsors and Collaborators

    • Centre Hospitalier Metropole Savoie

    Investigators

    • Principal Investigator: Valérie Roullot-Pradel, CH Metropole Savoie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Metropole Savoie
    ClinicalTrials.gov Identifier:
    NCT04536155
    Other Study ID Numbers:
    • CHMS19002
    First Posted:
    Sep 2, 2020
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Metropole Savoie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 15, 2022