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

Chronic Pain Clinical Trial

— QOLPain  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04536155
• Other study ID #: CHMS19002
• Status: Recruiting
• Start date: January 2, 2020
• Est. completion date: October 2, 2023

Study information

• Verified date: June 2022
• Source: Centre Hospitalier Metropole Savoie
• Contact: Patricia TRIOLO
• Phone: 04.79.96.58.36
• Email: patricia.triolo[@]ch-metropole-savoie.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 2, 2023
• Est. primary completion date: October 2, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• questionnary SF36
This is a validate questionnary: Ware et al,1992, McHorney et al, 1993, McHorney et al, 1994 French version : Author : Alain Leple`ge; et coll. En 2001
• Hospital Anxiety and Depression Scale
this is a validate scale: author: Zigmond A.S., Snaith R.P. in 1983
• Chronic Pain Acceptance Questionnaire
This is a validate questionnaire: Fish, R., McGuire, B.E., Hogan, M., Stewart, I. & Morrison, T. (2010).
• digital pain scale
this is a validate scale A.N.A.E.S. February 1999

Locations

Country	Name	City	State
France	CH Metropole Savoie	Chambéry

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Metropole Savoie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Change in anxiety and depression	assessed by HADS	Comparison at different moments in time - beginning, end, 6 months after, 12 months after
Secondary	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
Secondary	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
Secondary	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