WELL-being Improvement Following Sophrology Practice

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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WELL-being Improvement Following Sophrology Practice

Conditions
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Well-being

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sophrology practitioners<br>Practice sophrology - no intervention | |
| non practitioners<br>Do not practice sophrology - no intervention | |

What is the study measuring?
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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 |