Clinical trial NCT05888415: WELL-being Improvement Following Sophrology Practice
Official title: WELL-being Improvement Following Sophrology Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Well-being
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: DHEAS
timeFrame: Baseline
measure: Cortisol
timeFrame: Baseline
measure: Leptine
timeFrame: Baseline
measure: Ghrelin
timeFrame: Baseline
measure: DHEAS
timeFrame: month 1
measure: Cortisol
timeFrame: month 1
measure: Leptin
timeFrame: month 1
measure: Ghrelin
timeFrame: month 1
measure: DHEAS
timeFrame: month 2
measure: Cortisol
timeFrame: month 2
measure: Leptin
timeFrame: month 2
measure: Ghrelin
timeFrame: month 2
measure: DHEAS
timeFrame: month 3
measure: Cortisol
timeFrame: month 3
measure: Leptin
timeFrame: month 3
measure: Ghrelin
timeFrame: month 3
measure: DHEAS
timeFrame: month 4
measure: Cortisol
timeFrame: month 4
measure: Leptin
timeFrame: month 4
measure: Ghrelin
timeFrame: month 4
measure: DHEAS
timeFrame: month 5
measure: Cortisol
timeFrame: month 5
measure: Leptin
timeFrame: month 5
measure: Ghrelin
timeFrame: month 5
measure: DHEAS
timeFrame: month 6
measure: Cortisol
timeFrame: month 6
measure: Leptin
timeFrame: month 6
measure: Ghrelin
timeFrame: month 6
measure: Subjective stress
timeFrame: Baseline
measure: Subjective stress
timeFrame: Month 1
measure: Subjective stress
timeFrame: Month 2
measure: Subjective stress
timeFrame: Month 3
measure: Subjective stress
timeFrame: Month 4
measure: Subjective stress
timeFrame: Month 5
measure: Subjective stress
timeFrame: Month 6
Secondary outcomes:
measure: Sociodemographic
timeFrame: once at baseline
measure: Sophrology practice
timeFrame: once at baseline
measure: Drug treatment
timeFrame: Baseline
measure: Drug treatment
timeFrame: Month 1
measure: Drug treatment
timeFrame: Month 2
measure: Drug treatment
timeFrame: Month 3
measure: Drug treatment
timeFrame: Month 4
measure: Drug treatment
timeFrame: Month 5
measure: Drug treatment
timeFrame: Month 6
measure: Tobacco consumption
timeFrame: Baseline
measure: Coffee consumption
timeFrame: Baseline
measure: Tea consumption
timeFrame: Baseline
measure: Tobacco consumption
timeFrame: Month 1
measure: Coffee consumption
timeFrame: Month 1
measure: Tea consumption
timeFrame: Month 1
measure: Tobacco consumption
timeFrame: Month 2
measure: Coffee consumption
timeFrame: Month 2
measure: Tea consumption
timeFrame: Month 2
measure: Tobacco consumption
timeFrame: Month 3
measure: Coffee consumption
timeFrame: Month 3
measure: Tea consumption
timeFrame: Month 3
measure: Tobacco consumption
timeFrame: Month 4
measure: Coffee consumption
timeFrame: Month 4
measure: Tea consumption
timeFrame: Month 4
measure: Tobacco consumption
timeFrame: Month 5
measure: Coffee consumption
timeFrame: Month 5
measure: Tea consumption
timeFrame: Month 5
measure: Tobacco consumption
timeFrame: Month 6
measure: Coffee consumption
timeFrame: Month 6
measure: Tea consumption
timeFrame: Month 6
measure: Alcohol consumption
timeFrame: Baseline
measure: Cannabis consumption
timeFrame: Baseline
measure: Alcohol consumption
timeFrame: Month 1
measure: Cannabis consumption
timeFrame: Month 1
measure: Alcohol consumption
timeFrame: Month 2
measure: Cannabis consumption
timeFrame: Month 2
measure: Alcohol consumption
timeFrame: Month 3
measure: Cannabis consumption
timeFrame: Month 3
measure: Alcohol consumption
timeFrame: Month 4
measure: Cannabis consumption
timeFrame: Month 4
measure: Alcohol consumption
timeFrame: Month 5
measure: Cannabis consumption
timeFrame: Month 5
measure: Alcohol consumption
timeFrame: Month 6
measure: Cannabis consumption
timeFrame: Month 6
measure: Food consumption
timeFrame: Baseline
measure: Food consumption
timeFrame: Month 1
measure: Food consumption
timeFrame: Month 2
measure: Food consumption
timeFrame: Month 3
measure: Food consumption
timeFrame: Month 4
measure: Food consumption
timeFrame: Month 5
measure: Food consumption
timeFrame: Month 6
measure: Physical activity
timeFrame: Baseline
measure: Physical activity
timeFrame: Month 1
measure: Physical activity
timeFrame: Month 2
measure: Physical activity
timeFrame: Month 3
measure: Physical activity
timeFrame: Month 4
measure: Physical activity
timeFrame: Month 5
measure: Physical activity
timeFrame: Month 6
measure: Well-being
timeFrame: Baseline
measure: Well-being
timeFrame: Month 1
measure: Well-being
timeFrame: Month 2
measure: Well-being
timeFrame: Month 3
measure: Well-being
timeFrame: Month 4
measure: Well-being
timeFrame: Month 5
measure: Well-being
timeFrame: Month 6
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clemront-Ferrand
Study officials:
References: