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

June 14, 2022 updated by: Centre Hospitalier Metropole Savoie

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
change of quality of life during the program
Time Frame: score at the end of the workshop compared to the score at the beginning
SF36 score
score at the end of the workshop compared to the score at the beginning

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: Comparison between the beginning of the program and twelve months after the end of the program.
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
Time Frame: Comparison at different moments in time - beginning, end, 6 months after, 12 months after
assessed by HADS
Comparison at different moments in time - beginning, end, 6 months after, 12 months after
Change in perceived pain
Time Frame: Assessment at the beginning of the program and 12 months after the end using a numerical pain scale
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
Time Frame: Comparison at different moments in time - beginning, end, 6 months after, 12 months after
assessed by Chronic Pain Acceptance Questionnaire
Comparison at different moments in time - beginning, end, 6 months after, 12 months after
Change in physical activity
Time Frame: Change in physical activity between the beginning of the program and 12 months after the end
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Metropole Savoie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valérie Roullot-Pradel, CH Métropole Savoie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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