Skip to main content
OpenTrials
Completed

NCT Number: NCT05888415

WELL-being Improvement Following Sophrology Practice

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Well-Being

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clemront-Ferrand

Clermont-Ferrand, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. DHEAS

    Time frame: Baseline

    Stress measure objectively using dheas measured in pg/ml

  2. Cortisol

    Time frame: Baseline

    Stress measure objectively using cortisol measured in µg/dl

  3. Leptine

    Time frame: Baseline

    Stress measure objectively using leptin measured in ng/ml

  4. Ghrelin

    Time frame: Baseline

    Stress measure objectively using ghrelin measured in pg/ml

  5. DHEAS

    Time frame: month 1

    Stress measure objectively using dheas measured in pg/ml

  6. Cortisol

    Time frame: month 1

    Stress measure objectively using cortisol measured in µg/dl

  7. Leptin

    Time frame: month 1

    Stress measure objectively using leptin measured in ng/ml

  8. Ghrelin

    Time frame: month 1

    Stress measure objectively using ghrelin measured in pg/ml

  9. DHEAS

    Time frame: month 2

    Stress measure objectively using dheas measured in pg/ml

  10. Cortisol

    Time frame: month 2

    Stress measure objectively using cortisol measured in µg/dl

  11. Leptin

    Time frame: month 2

    Stress measure objectively using leptin measured in ng/ml

  12. Ghrelin

    Time frame: month 2

    Stress measure objectively using ghrelin measured in pg/ml

  13. DHEAS

    Time frame: month 3

    Stress measure objectively using dheas measured in pg/ml

  14. Cortisol

    Time frame: month 3

    Stress measure objectively using cortisol measured in µg/dl

  15. Leptin

    Time frame: month 3

    Stress measure objectively using leptin measured in ng/ml

  16. Ghrelin

    Time frame: month 3

    Stress measure objectively using ghrelin measured in pg/ml

  17. DHEAS

    Time frame: month 4

    Stress measure objectively using dheas measured in pg/ml

  18. Cortisol

    Time frame: month 4

    Stress measure objectively using cortisol measured in µg/dl

  19. Leptin

    Time frame: month 4

    Stress measure objectively using leptin measured in ng/ml

  20. Ghrelin

    Time frame: month 4

    Stress measure objectively using ghrelin measured in pg/ml

  21. DHEAS

    Time frame: month 5

    Stress measure objectively using dheas measured in pg/ml

  22. Cortisol

    Time frame: month 5

    Stress measure objectively using cortisol measured in µg/dl

  23. Leptin

    Time frame: month 5

    Stress measure objectively using leptin measured in ng/ml

  24. Ghrelin

    Time frame: month 5

    Stress measure objectively using ghrelin measured in pg/ml

  25. DHEAS

    Time frame: month 6

    Stress measure objectively using dheas measured in pg/ml

  26. Cortisol

    Time frame: month 6

    Stress measure objectively using cortisol measured in µg/dl

  27. Leptin

    Time frame: month 6

    Stress measure objectively using leptin measured in ng/ml

  28. Ghrelin

    Time frame: month 6

    Stress measure objectively using ghrelin measured in pg/ml

  29. Subjective stress

    Time frame: Baseline

    stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  30. Subjective stress

    Time frame: Month 1

    stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  31. Subjective stress

    Time frame: Month 2

    stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  32. Subjective stress

    Time frame: Month 3

    stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  33. Subjective stress

    Time frame: Month 4

    stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  34. Subjective stress

    Time frame: Month 5

    stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  35. Subjective stress

    Time frame: Month 6

    stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

Secondary outcomes

  1. Sociodemographic

    Time frame: once at baseline

    gender, age, marital status, children, occupation, and recent stressful event

  2. Sophrology practice

    Time frame: once at baseline

    Type of sophrology practice using a multiple-choice question

  3. Drug treatment

    Time frame: Baseline

    Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."

  4. Drug treatment

    Time frame: Month 1

    Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."

  5. Drug treatment

    Time frame: Month 2

    Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."

  6. Drug treatment

    Time frame: Month 3

    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"

  7. Drug treatment

    Time frame: Month 4

    Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."

  8. Drug treatment

    Time frame: Month 5

    Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."

  9. Drug treatment

    Time frame: Month 6

    Multiple-choice question: "Do you take long-term medication? No treatment, Psychotropics, Sleeping pills, Antihypertensives, etc."

  10. Tobacco consumption

    Time frame: Baseline

    Average number of cigarettes per day over the past month

  11. Coffee consumption

    Time frame: Baseline

    Average number of cups of coffee per day over the past month

  12. Tea consumption

    Time frame: Baseline

    Average number of cups of tea per day over the past month

  13. Tobacco consumption

    Time frame: Month 1

    Average number of cigarettes per day over the past month

  14. Coffee consumption

    Time frame: Month 1

    Average number of cups of coffee per day over the past month

  15. Tea consumption

    Time frame: Month 1

    Average number of cups of tea per day over the past month

  16. Tobacco consumption

    Time frame: Month 2

    Average number of cigarettes per day over the past month

  17. Coffee consumption

    Time frame: Month 2

    Average number of cups of coffee per day over the past month

  18. Tea consumption

    Time frame: Month 2

    Average number of cups of tea per day over the past month

  19. Tobacco consumption

    Time frame: Month 3

    Average number of cigarettes per day over the past month

  20. Coffee consumption

    Time frame: Month 3

    Average number of cups of coffee per day over the past month

  21. Tea consumption

    Time frame: Month 3

    Average number of cups of tea per day over the past month

  22. Tobacco consumption

    Time frame: Month 4

    Average number of cigarettes per day over the past month

  23. Coffee consumption

    Time frame: Month 4

    Average number of cups of coffee per day over the past month

  24. Tea consumption

    Time frame: Month 4

    Average number of cups of tea per day over the past month

  25. Tobacco consumption

    Time frame: Month 5

    Average number of cigarettes per day over the past month

  26. Coffee consumption

    Time frame: Month 5

    Average number of cups of coffee per day over the past month

  27. Tea consumption

    Time frame: Month 5

    Average number of cups of tea per day over the past month

  28. Tobacco consumption

    Time frame: Month 6

    Average number of cigarettes per day over the past month

  29. Coffee consumption

    Time frame: Month 6

    Average number of cups of coffee per day over the past month

  30. Tea consumption

    Time frame: Month 6

    Average number of cups of tea per day over the past month

  31. Alcohol consumption

    Time frame: Baseline

    Average number of alcoholic drinks per week

  32. Cannabis consumption

    Time frame: Baseline

    Average number of cannabis joints per week

  33. Alcohol consumption

    Time frame: Month 1

    Average number of alcoholic drinks per week

  34. Cannabis consumption

    Time frame: Month 1

    Average number of cannabis joints per week

  35. Alcohol consumption

    Time frame: Month 2

    Average number of alcoholic drinks per week

  36. Cannabis consumption

    Time frame: Month 2

    Average number of cannabis joints per week

  37. Alcohol consumption

    Time frame: Month 3

    Average number of alcoholic drinks per week

  38. Cannabis consumption

    Time frame: Month 3

    Average number of cannabis joints per week

  39. Alcohol consumption

    Time frame: Month 4

    Average number of alcoholic drinks per week

  40. Cannabis consumption

    Time frame: Month 4

    Average number of cannabis joints per week

  41. Alcohol consumption

    Time frame: Month 5

    Average number of alcoholic drinks per week

  42. Cannabis consumption

    Time frame: Month 5

    Average number of cannabis joints per week

  43. Alcohol consumption

    Time frame: Month 6

    Average number of alcoholic drinks per week

  44. Cannabis consumption

    Time frame: Month 6

    Average number of cannabis joints per week

  45. Food consumption

    Time frame: Baseline

    Average food consumption in the last month

  46. Food consumption

    Time frame: Month 1

    Average food consumption in the last month

  47. Food consumption

    Time frame: Month 2

    Average food consumption in the last month

  48. Food consumption

    Time frame: Month 3

    Average food consumption in the last month

  49. Food consumption

    Time frame: Month 4

    Average food consumption in the last month

  50. Food consumption

    Time frame: Month 5

    Average food consumption in the last month

  51. Food consumption

    Time frame: Month 6

    Average food consumption in the last month

  52. Physical activity

    Time frame: Baseline

    Average number of hours of physical activity per week over the past month

  53. Physical activity

    Time frame: Month 1

    Average number of hours of physical activity per week over the past month

  54. Physical activity

    Time frame: Month 2

    Average number of hours of physical activity per week over the past month

  55. Physical activity

    Time frame: Month 3

    Average number of hours of physical activity per week over the past month

  56. Physical activity

    Time frame: Month 4

    Average number of hours of physical activity per week over the past month

  57. Physical activity

    Time frame: Month 5

    Average number of hours of physical activity per week over the past month

  58. Physical activity

    Time frame: Month 6

    Average number of hours of physical activity per week over the past month

  59. Well-being

    Time frame: Baseline

    Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  60. Well-being

    Time frame: Month 1

    Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  61. Well-being

    Time frame: Month 2

    Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  62. Well-being

    Time frame: Month 3

    Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  63. Well-being

    Time frame: Month 4

    Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  64. Well-being

    Time frame: Month 5

    Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

  65. Well-being

    Time frame: Month 6

    Well-being measured using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Acronym: SoWell-Learn

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2023
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.