Chronic PainQOLPainNCT04536155
Observational Study of the Quality of Life for the Chronic Pain Patients Included in a Therapeutic Education Program Focused on Relaxation Techniques
An observational study of Chronic Pain, run by Centre Hospitalier Metropole Savoie at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- questionnary SF36, Hospital Anxiety and Depression Scale and Chronic Pain Acceptance Questionnaire
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2020to 2 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patient with chronic pain for whom a group "relaxation techniques" programm is planned and accepted by the patient.
Who may be able to join
- chronic pain since more the 3months
- Patients for whom a group "relaxation techniques" program is planned and accepted by the patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CH Metropole Savoie
Chambéry, 73011
Patricia Triolo
Valérie Roullot-Pradel
About this study
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- questionnary SF36, Hospital Anxiety and Depression Scale, Chronic Pain Acceptance Questionnaire, digital pain scale
- Keywords
- visualization, abdominal respiration, synchronized breathing, Sophronisation, relaxation therapy, Do In self-massage, sophrology, breathing exercise, therapeutic education
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnary SF36Other
Also called 36 items Medical Outcome Study Short Form health survey
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
Hospital Anxiety and Depression ScaleOther
Also called HADS
this is a validate scale: author: Zigmond A.S., Snaith R.P. in 1983
Chronic Pain Acceptance QuestionnaireOther
Also called CPAQ
This is a validate questionnaire:
Fish, R., McGuire, B.E., Hogan, M., Stewart, I. \& Morrison, T. (2010).
digital pain scaleOther
this is a validate scale A.N.A.E.S. February 1999
| Study group | Role | What they receive |
|---|---|---|
| patient with chronic pain | Not described Receives: Other: questionnary SF36; Other: Hospital Anxiety and Depression Scale; Other: Chronic Pain Acceptance Questionnaire; Other: digital pain scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of quality of life during the program
SF36 score
Measured: score at the end of the workshop compared to the score at the beginning
Secondary outcomes (5)
Change in quality of life
assessed by sf36 score
Measured: Comparison between the beginning of the program and twelve months after the end of the program.
Change in anxiety and depression
assessed by HADS
Measured: Comparison at different moments in time - beginning, end, 6 months after, 12 months after
Change in perceived pain
assessed by numeric pain scale
Measured: 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
Measured: 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
Measured: Change in physical activity between the beginning of the program and 12 months after the end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start2 Jan 2020
- Primary completion2 Oct 2022 (estimated)
- Study completion2 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Roullot-Pradel, Principal investigator, CH Metropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536155
- Sponsor's protocol ID
- CHMS19002
- Acronym
- QOLPain
- Status last verified
- Jun 2022
- First submitted
- 7 Jan 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Quality of Life for the Chronic Pain Patients Included in a Therapeutic Education Program Focused on Relaxation Techniques
- ClinicalTrials.gov ID
- NCT04536155
- Acronym / sponsor ID
- QOLPain / CHMS19002
- Conditions
- Chronic Pain
- Keywords
- visualization, abdominal respiration, synchronized breathing, Sophronisation, relaxation therapy, Do In self-massage, sophrology, breathing exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 2 Oct 2022 (estimated)
- Study completion
- 2 Oct 2023 (estimated)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with chronic pain | – | Other: questionnary SF36, Other: Hospital Anxiety and Depression Scale, Other: Chronic Pain Acceptance Questionnaire, Other: digital pain scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient with chronic pain for whom a group "relaxation techniques" programm is planned and accepted by the patient.
Key inclusion criteria (2 listed)
- chronic pain since more the 3months
- Patients for whom a group "relaxation techniques" program is planned and accepted by the patient
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnary SF36Also: 36 items Medical Outcome Study Short Form health surveyThis 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 | patient with chronic pain |
| Hospital Anxiety and Depression ScaleAlso: HADSthis is a validate scale: author: Zigmond A.S., Snaith R.P. in 1983 | Other | patient with chronic pain |
| Chronic Pain Acceptance QuestionnaireAlso: CPAQThis is a validate questionnaire: Fish, R., McGuire, B.E., Hogan, M., Stewart, I. \& Morrison, T. (2010). | Other | patient with chronic pain |
| digital pain scalethis is a validate scale A.N.A.E.S. February 1999 | Other | patient with chronic pain |
Primary outcome
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
5 secondary outcomes
Change in quality of life
Time frame: 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
Change in perceived pain
Time frame: 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
Change in physical activity
Time frame: Change in physical activity between the beginning of the program and 12 months after the end
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Roullot-Pradel principal investigator
CH Metropole Savoie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Centre Hospitalier Metropole Savoie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia TRIOLO (04.79.96.58.36 ext. 33, patricia.triolo@ch-metropole-savoie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of quality of life during the program (time frame: score at the end of the workshop compared to the score at the beginning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.