Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2023-06-19
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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sophrology practitioners
Practice sophrology - no intervention
No interventions assigned to this group
non practitioners
Do not practice sophrology - no intervention
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Refusal to participate
ALL
Yes
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Locations
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CHU Clemront-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RNI 2022 DUTHEIL 2
Identifier Type: -
Identifier Source: org_study_id