WELL-being Improvement Following Sophrology Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- DHEAS
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Protected persons (minors, pregnant women, breastfeeding women, guardianship, curatorship, deprived of freedoms, safeguard of justice)
- •Refusal to participate
研究组 & 干预措施
sophrology practitioners
Practice sophrology - no intervention
non practitioners
Do not practice sophrology - no intervention
结局指标
主要结局
DHEAS
时间窗: month 6
Stress measure objectively using dheas measured in pg/ml
Leptine
时间窗: Baseline
Stress measure objectively using leptin measured in ng/ml
Leptin
时间窗: month 6
Stress measure objectively using leptin measured in ng/ml
Cortisol
时间窗: month 6
Stress measure objectively using cortisol measured in µg/dl
Subjective stress
时间窗: Month 6
stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)
Ghrelin
时间窗: month 6
Stress measure objectively using ghrelin measured in pg/ml
DHEAS
时间窗: Baseline
Stress measure objectively using dheas measured in pg/ml
Cortisol
时间窗: Baseline
Stress measure objectively using cortisol measured in µg/dl
Ghrelin
时间窗: Baseline
Stress measure objectively using ghrelin measured in pg/ml
DHEAS
时间窗: month 1
Stress measure objectively using dheas measured in pg/ml
Cortisol
时间窗: month 1
Stress measure objectively using cortisol measured in µg/dl
Leptin
时间窗: month 1
Stress measure objectively using leptin measured in ng/ml
Ghrelin
时间窗: month 1
Stress measure objectively using ghrelin measured in pg/ml
DHEAS
时间窗: month 2
Stress measure objectively using dheas measured in pg/ml
Cortisol
时间窗: month 2
Stress measure objectively using cortisol measured in µg/dl
Leptin
时间窗: month 2
Stress measure objectively using leptin measured in ng/ml
Ghrelin
时间窗: month 2
Stress measure objectively using ghrelin measured in pg/ml
DHEAS
时间窗: month 3
Stress measure objectively using dheas measured in pg/ml
Cortisol
时间窗: month 3
Stress measure objectively using cortisol measured in µg/dl
Leptin
时间窗: month 3
Stress measure objectively using leptin measured in ng/ml
Ghrelin
时间窗: month 3
Stress measure objectively using ghrelin measured in pg/ml
DHEAS
时间窗: month 4
Stress measure objectively using dheas measured in pg/ml
Cortisol
时间窗: month 4
Stress measure objectively using cortisol measured in µg/dl
Leptin
时间窗: month 4
Stress measure objectively using leptin measured in ng/ml
Ghrelin
时间窗: month 4
Stress measure objectively using ghrelin measured in pg/ml
DHEAS
时间窗: month 5
Stress measure objectively using dheas measured in pg/ml
Cortisol
时间窗: month 5
Stress measure objectively using cortisol measured in µg/dl
Leptin
时间窗: month 5
Stress measure objectively using leptin measured in ng/ml
Ghrelin
时间窗: month 5
Stress measure objectively using ghrelin measured in pg/ml
Subjective stress
时间窗: Baseline
stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)
Subjective stress
时间窗: Month 1
stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)
Subjective stress
时间窗: Month 2
stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)
Subjective stress
时间窗: Month 3
stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)
Subjective stress
时间窗: Month 4
stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)
Subjective stress
时间窗: Month 5
stress measure subjectively using a visual analogue scale ranging from 0 (minimum) to 100 (maximum)
次要结局
- Sophrology practice(once at baseline)
- Food consumption(Month 6)
- Well-being(Month 6)
- Coffee consumption(Month 6)
- Tea consumption(Month 6)
- Drug treatment(Month 6)
- Sociodemographic(once at baseline)
- Tobacco consumption(Month 6)
- Physical activity(Month 6)
- Alcohol consumption(Month 6)
- Cannabis consumption(Month 6)
- Drug treatment(Baseline)
- Drug treatment(Month 1)
- Drug treatment(Month 2)
- Drug treatment(Month 3)
- Drug treatment(Month 4)
- Drug treatment(Month 5)
- Tobacco consumption(Baseline)
- Coffee consumption(Baseline)
- Tea consumption(Baseline)
- Tobacco consumption(Month 1)
- Coffee consumption(Month 1)
- Tea consumption(Month 1)
- Tobacco consumption(Month 2)
- Coffee consumption(Month 2)
- Tea consumption(Month 2)
- Tobacco consumption(Month 3)
- Coffee consumption(Month 3)
- Tea consumption(Month 3)
- Tobacco consumption(Month 4)
- Coffee consumption(Month 4)
- Tea consumption(Month 4)
- Tobacco consumption(Month 5)
- Coffee consumption(Month 5)
- Tea consumption(Month 5)
- Alcohol consumption(Baseline)
- Cannabis consumption(Baseline)
- Alcohol consumption(Month 1)
- Cannabis consumption(Month 1)
- Alcohol consumption(Month 2)
- Cannabis consumption(Month 2)
- Alcohol consumption(Month 3)
- Cannabis consumption(Month 3)
- Alcohol consumption(Month 4)
- Cannabis consumption(Month 4)
- Alcohol consumption(Month 5)
- Cannabis consumption(Month 5)
- Food consumption(Baseline)
- Food consumption(Month 1)
- Food consumption(Month 2)
- Food consumption(Month 3)
- Food consumption(Month 4)
- Food consumption(Month 5)
- Physical activity(Baseline)
- Physical activity(Month 1)
- Physical activity(Month 2)
- Physical activity(Month 3)
- Physical activity(Month 4)
- Physical activity(Month 5)
- Well-being(Baseline)
- Well-being(Month 1)
- Well-being(Month 2)
- Well-being(Month 3)
- Well-being(Month 4)
- Well-being(Month 5)