WELL-being Improvement Following Sophrology Practice (SoWell-Learn)

Stress and psychosocial risks are a major public health problem.Sophrology is a psycho-corporal method exclusively verbal and non-tactile used as a therapeutic technique. It combines a set of techniques that will act both on the body and on the mind through breathing exercises, muscle relaxation and mental imagery (or visualization). It allows to find a state of well-being and to activate all physical and psychological potential in order to acquire a better knowledge of oneself. Sophrology demonstrated some benefits on symptoms of patients. However, these approaches have never been evaluated with a prolonged follow-up of several months, with biological measures or with adjustments according to the levels of mastery of sophrology. This project proposes to evaluate the effects of sophrology practice. The investigators aim to evaluate both subjective and objective measures of stress.

Study Overview

• Status: Completed
• Conditions: Well-being

Detailed Description

Those interested in participating in the study will contact the investigators via the email address provided on the flyer. A clinical research associate will contact them and give them an appointment at the Institute of Occupational Medicine, Faculty of Medicine, 28 place Henri Dunant, 63000 Clermont-Ferrand, in order to provide them with informed information and respond to their their questions.

If participants agree to participate, the clinical research associate will provide them with the saliva collection kit with instructions for use and a Redcap® link to inform their commitment, and complete an inclusion questionnaire and the first main questionnaire. Then, the participants will receive the questionnaire directly by email for the following fillings.

When accessing Redcap®, a brief description of the study will again be provided. We will ask the participant to commit to their group's inclusion criteria by checking a box. The non-opposition will be collected by clicking on "envoyer" at the end of the information letter. The following sentence will be indicated "In the case of an agreement please click on the button "envoyer".

After collection of the non-opposition, participant will have to completed a short inclusion questionnaire composed of:

• Initials for create an ID
• Sociodemographic variables: gender, age, marital status, children, occupation, and recent stressful event.
• Group : " pratiquant " or " non pratiquant ". For those practicing sophrology: type of practice and number of years of practice
• Realization of another wellness practice
• Email address to be able to receive the questionnaires each month by automatic sending. In order to guarantee anonymity, the email address of the participants will not be accessible to the investigators / collaborators of the study. They will thus be contacted by email directly by REDCap® for the questionnaire filling (identical questionnaire each month during 6 months).

The self-administered main questionnaire will be composed of:

• Information about saliva sampling: Date and time of collection, Time of awakening on day of collection, Eppendorf number
• Visual analog scales assessing the perceived stress, anxiety, sleep quality, fatigue, time judgment and emotions on a horizontal, non-calibrated line of 100 mm, ranging from very low (0) to very high (100).
• Lifestyle variables: treatment, physical activity, addiction (alcohol, cannabis, and tobacco), coffee/tea and food intake.
• Sophrology practice: Number of sessions per week, type of practice, stress before and after the last sophrology session, realization of another wellness practice

Furthermore, each participant will do a self-collection of saliva the first week of each month, upon waking up, on a day of the week chosen by the participant as being as reproducible as possible. Participants will have to keep the samples in their freezer and bring them back to us in an ice pack at the end of the 6 months. For this purpose, in the last questionnaire, we will display a window asking them to contact us to organise the return of their saliva samples.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clemront-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study is composed of a group of people practicing sophrology and a group of people who do not practice it

Description

Inclusion criteria

For both groups (sophro-practitioners vs. non-practitioners), being able to give informed consent to participate in the research. Commit to respecting the inclusion criteria of their group.

• For sophro-practitioners:

  • practice at least once a week,
  • practice vertically following the dynamic relaxation method.
• For non-practitioners, do not practice sophrology during the follow-up. If the participant changes his mind, he will be asked to inform the investigator.

Exclusion Criteria:

• Protected persons (minors, pregnant women, breastfeeding women, guardianship, curatorship, deprived of freedoms, safeguard of justice)
• Refusal to participate

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
sophrology practitioners; Practice sophrology - no intervention
non practitioners; Do not practice sophrology - no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DHEAS	Stress measure objectively using dheas measured in pg/ml	Baseline
Cortisol	Stress measure objectively using cortisol measured in µg/dl	Baseline
Leptine	Stress measure objectively using leptin measured in ng/ml	Baseline
Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	Baseline
DHEAS	Stress measure objectively using dheas measured in pg/ml	month 1
Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 1
Leptin	Stress measure objectively using leptin measured in ng/ml	month 1
Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 1
DHEAS	Stress measure objectively using dheas measured in pg/ml	month 2
Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 2
Leptin	Stress measure objectively using leptin measured in ng/ml	month 2
Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 2
DHEAS	Stress measure objectively using dheas measured in pg/ml	month 3
Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 3
Leptin	Stress measure objectively using leptin measured in ng/ml	month 3
Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 3
DHEAS	Stress measure objectively using dheas measured in pg/ml	month 4
Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 4
Leptin	Stress measure objectively using leptin measured in ng/ml	month 4
Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 4
DHEAS	Stress measure objectively using dheas measured in pg/ml	month 5
Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 5
Leptin	Stress measure objectively using leptin measured in ng/ml	month 5
Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 5
DHEAS	Stress measure objectively using dheas measured in pg/ml	month 6
Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 6
Leptin	Stress measure objectively using leptin measured in ng/ml	month 6
Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 6
Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Baseline
Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 1
Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 2
Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 3
Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 4
Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 5
Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic	gender, age, marital status, children, occupation, and recent stressful event	once at baseline
Sophrology practice	Type of sophrology practice using a multiple-choice question	once at baseline
Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Baseline
Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 1
Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 2
Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc." If yes, "type of treatment" and "number of tablets per day"	Month 3
Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 4
Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 5
Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 6
Tobacco consumption	Average number of cigarettes per day over the past month	Baseline
Coffee consumption	Average number of cups of coffee per day over the past month	Baseline
Tea consumption	Average number of cups of tea per day over the past month	Baseline
Tobacco consumption	Average number of cigarettes per day over the past month	Month 1
Coffee consumption	Average number of cups of coffee per day over the past month	Month 1
Tea consumption	Average number of cups of tea per day over the past month	Month 1
Tobacco consumption	Average number of cigarettes per day over the past month	Month 2
Coffee consumption	Average number of cups of coffee per day over the past month	Month 2
Tea consumption	Average number of cups of tea per day over the past month	Month 2
Tobacco consumption	Average number of cigarettes per day over the past month	Month 3
Coffee consumption	Average number of cups of coffee per day over the past month	Month 3
Tea consumption	Average number of cups of tea per day over the past month	Month 3
Tobacco consumption	Average number of cigarettes per day over the past month	Month 4
Coffee consumption	Average number of cups of coffee per day over the past month	Month 4
Tea consumption	Average number of cups of tea per day over the past month	Month 4
Tobacco consumption	Average number of cigarettes per day over the past month	Month 5
Coffee consumption	Average number of cups of coffee per day over the past month	Month 5
Tea consumption	Average number of cups of tea per day over the past month	Month 5
Tobacco consumption	Average number of cigarettes per day over the past month	Month 6
Coffee consumption	Average number of cups of coffee per day over the past month	Month 6
Tea consumption	Average number of cups of tea per day over the past month	Month 6
Alcohol consumption	Average number of alcoholic drinks per week	Baseline
Cannabis consumption	Average number of cannabis joints per week	Baseline
Alcohol consumption	Average number of alcoholic drinks per week	Month 1
Cannabis consumption	Average number of cannabis joints per week	Month 1
Alcohol consumption	Average number of alcoholic drinks per week	Month 2
Cannabis consumption	Average number of cannabis joints per week	Month 2
Alcohol consumption	Average number of alcoholic drinks per week	Month 3
Cannabis consumption	Average number of cannabis joints per week	Month 3
Alcohol consumption	Average number of alcoholic drinks per week	Month 4
Cannabis consumption	Average number of cannabis joints per week	Month 4
Alcohol consumption	Average number of alcoholic drinks per week	Month 5
Cannabis consumption	Average number of cannabis joints per week	Month 5
Alcohol consumption	Average number of alcoholic drinks per week	Month 6
Cannabis consumption	Average number of cannabis joints per week	Month 6
Food consumption	Average food consumption in the last month	Baseline
Food consumption	Average food consumption in the last month	Month 1
Food consumption	Average food consumption in the last month	Month 2
Food consumption	Average food consumption in the last month	Month 3
Food consumption	Average food consumption in the last month	Month 4
Food consumption	Average food consumption in the last month	Month 5
Food consumption	Average food consumption in the last month	Month 6
Physical activity	Average number of hours of physical activity per week over the past month	Baseline
Physical activity	Average number of hours of physical activity per week over the past month	Month 1
Physical activity	Average number of hours of physical activity per week over the past month	Month 2
Physical activity	Average number of hours of physical activity per week over the past month	Month 3
Physical activity	Average number of hours of physical activity per week over the past month	Month 4
Physical activity	Average number of hours of physical activity per week over the past month	Month 5
Physical activity	Average number of hours of physical activity per week over the past month	Month 6
Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Baseline
Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 1
Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 2
Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 3
Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 4
Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 5
Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2023
• Primary Completion (Actual): May 6, 2026
• Study Completion (Actual): May 6, 2026

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RNI 2022 DUTHEIL 2

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