WELL-being Improvement Following Sophrology Practice

Well-being Clinical Trial

— SoWell-Learn  

Official title:

WELL-being Improvement Following Sophrology Practice

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05888415
• Other study ID #: RNI 2022 DUTHEIL 2
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2025

Study information

• Verified date: April 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 04 73 75 11 95
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Well-being

Locations

Country	Name	City	State
France	CHU Clemront-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DHEAS	Stress measure objectively using dheas measured in pg/ml	Baseline
Primary	Cortisol	Stress measure objectively using cortisol measured in µg/dl	Baseline
Primary	Leptine	Stress measure objectively using leptin measured in ng/ml	Baseline
Primary	Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	Baseline
Primary	DHEAS	Stress measure objectively using dheas measured in pg/ml	month 1
Primary	Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 1
Primary	Leptin	Stress measure objectively using leptin measured in ng/ml	month 1
Primary	Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 1
Primary	DHEAS	Stress measure objectively using dheas measured in pg/ml	month 2
Primary	Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 2
Primary	Leptin	Stress measure objectively using leptin measured in ng/ml	month 2
Primary	Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 2
Primary	DHEAS	Stress measure objectively using dheas measured in pg/ml	month 3
Primary	Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 3
Primary	Leptin	Stress measure objectively using leptin measured in ng/ml	month 3
Primary	Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 3
Primary	DHEAS	Stress measure objectively using dheas measured in pg/ml	month 4
Primary	Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 4
Primary	Leptin	Stress measure objectively using leptin measured in ng/ml	month 4
Primary	Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 4
Primary	DHEAS	Stress measure objectively using dheas measured in pg/ml	month 5
Primary	Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 5
Primary	Leptin	Stress measure objectively using leptin measured in ng/ml	month 5
Primary	Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 5
Primary	DHEAS	Stress measure objectively using dheas measured in pg/ml	month 6
Primary	Cortisol	Stress measure objectively using cortisol measured in µg/dl	month 6
Primary	Leptin	Stress measure objectively using leptin measured in ng/ml	month 6
Primary	Ghrelin	Stress measure objectively using ghrelin measured in pg/ml	month 6
Primary	Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Baseline
Primary	Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 1
Primary	Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 2
Primary	Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 3
Primary	Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 4
Primary	Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 5
Primary	Subjective stress	stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 6
Secondary	Sociodemographic	gender, age, marital status, children, occupation, and recent stressful event	once at baseline
Secondary	Sophrology practice	Type of sophrology practice using a multiple-choice question	once at baseline
Secondary	Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Baseline
Secondary	Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 1
Secondary	Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 2
Secondary	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
Secondary	Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 4
Secondary	Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 5
Secondary	Drug treatment	Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."	Month 6
Secondary	Tobacco consumption	Average number of cigarettes per day over the past month	Baseline
Secondary	Coffee consumption	Average number of cups of coffee per day over the past month	Baseline
Secondary	Tea consumption	Average number of cups of tea per day over the past month	Baseline
Secondary	Tobacco consumption	Average number of cigarettes per day over the past month	Month 1
Secondary	Coffee consumption	Average number of cups of coffee per day over the past month	Month 1
Secondary	Tea consumption	Average number of cups of tea per day over the past month	Month 1
Secondary	Tobacco consumption	Average number of cigarettes per day over the past month	Month 2
Secondary	Coffee consumption	Average number of cups of coffee per day over the past month	Month 2
Secondary	Tea consumption	Average number of cups of tea per day over the past month	Month 2
Secondary	Tobacco consumption	Average number of cigarettes per day over the past month	Month 3
Secondary	Coffee consumption	Average number of cups of coffee per day over the past month	Month 3
Secondary	Tea consumption	Average number of cups of tea per day over the past month	Month 3
Secondary	Tobacco consumption	Average number of cigarettes per day over the past month	Month 4
Secondary	Coffee consumption	Average number of cups of coffee per day over the past month	Month 4
Secondary	Tea consumption	Average number of cups of tea per day over the past month	Month 4
Secondary	Tobacco consumption	Average number of cigarettes per day over the past month	Month 5
Secondary	Coffee consumption	Average number of cups of coffee per day over the past month	Month 5
Secondary	Tea consumption	Average number of cups of tea per day over the past month	Month 5
Secondary	Tobacco consumption	Average number of cigarettes per day over the past month	Month 6
Secondary	Coffee consumption	Average number of cups of coffee per day over the past month	Month 6
Secondary	Tea consumption	Average number of cups of tea per day over the past month	Month 6
Secondary	Alcohol consumption	Average number of alcoholic drinks per week	Baseline
Secondary	Cannabis consumption	Average number of cannabis joints per week	Baseline
Secondary	Alcohol consumption	Average number of alcoholic drinks per week	Month 1
Secondary	Cannabis consumption	Average number of cannabis joints per week	Month 1
Secondary	Alcohol consumption	Average number of alcoholic drinks per week	Month 2
Secondary	Cannabis consumption	Average number of cannabis joints per week	Month 2
Secondary	Alcohol consumption	Average number of alcoholic drinks per week	Month 3
Secondary	Cannabis consumption	Average number of cannabis joints per week	Month 3
Secondary	Alcohol consumption	Average number of alcoholic drinks per week	Month 4
Secondary	Cannabis consumption	Average number of cannabis joints per week	Month 4
Secondary	Alcohol consumption	Average number of alcoholic drinks per week	Month 5
Secondary	Cannabis consumption	Average number of cannabis joints per week	Month 5
Secondary	Alcohol consumption	Average number of alcoholic drinks per week	Month 6
Secondary	Cannabis consumption	Average number of cannabis joints per week	Month 6
Secondary	Food consumption	Average food consumption in the last month	Baseline
Secondary	Food consumption	Average food consumption in the last month	Month 1
Secondary	Food consumption	Average food consumption in the last month	Month 2
Secondary	Food consumption	Average food consumption in the last month	Month 3
Secondary	Food consumption	Average food consumption in the last month	Month 4
Secondary	Food consumption	Average food consumption in the last month	Month 5
Secondary	Food consumption	Average food consumption in the last month	Month 6
Secondary	Physical activity	Average number of hours of physical activity per week over the past month	Baseline
Secondary	Physical activity	Average number of hours of physical activity per week over the past month	Month 1
Secondary	Physical activity	Average number of hours of physical activity per week over the past month	Month 2
Secondary	Physical activity	Average number of hours of physical activity per week over the past month	Month 3
Secondary	Physical activity	Average number of hours of physical activity per week over the past month	Month 4
Secondary	Physical activity	Average number of hours of physical activity per week over the past month	Month 5
Secondary	Physical activity	Average number of hours of physical activity per week over the past month	Month 6
Secondary	Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Baseline
Secondary	Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 1
Secondary	Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 2
Secondary	Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 3
Secondary	Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 4
Secondary	Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 5
Secondary	Well-being	Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)	Month 6