Stress Clinical Trial
— ThermStressOfficial title:
Effects of a Thermal Spa Short Residential Program for Prevention of Work-related Stress / Burn-out on Biomarkers of Stress - A Proof of Concept Study
Work-related stress is a public health issue. Among the multiple physical and psychological
consequences of stress, increased mortality and cardiovascular morbidity seem the main
concern. The thermal spa resort of Néris-Les-Bains is one of the five spa resorts in France
specialized in the treatment of psychosomatic disorders. Among all these resorts proposing a
thermal residential program of three weeks, only one thermal spa resort (Saujon) has a
program for occupational burn-out. However, a shorter thermal spa residential program seems
more compatible with professional context (availability of individuals), and focusing on
work-related stress prevention (before the state of burn-out).
The main hypothesis is that a short thermal spa residential program (6 days) of work-related
stress prevention will exhibit its efficacy through objective measures of well-being and
cardiovascular morbidity.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 1, 2021 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Workers with a visual analog scale of stress greater than 50 mm - from 18 years to retirement - written informed consent - Affiliation to French health care system (for France) Exclusion Criteria: - Participant refusal to participate |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | AME2P Laboratory (EA 3533), University Clermont Auvergne, Clermont-Ferrand, France, Auvergne Rhone Alpes Regional Council (Région Auvergne Rhône Alpes), Clermont-Ferrand, France, EIPAS, Stress at work preventive center, Auvergne, France, European Regional Development Fund (FEDER - Fonds Européen de Développement Economique et Régional), Innova-Therm, Auvergne, France, LaPEC laboratory (EA 4278), Avignon University, Avignon, France, Spa resort of Néris-les-Bains, SEMETT, 6 place des Thermes, 03310 Néris-les-Bains, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | heart rate variability | To assess the ability of a short spa residential program of management of work-related stress in increasing heart rate variability, a biomarker of both stress and morbidity/mortality. Heart rate variability will be measured by zephyr during 26h recording time |
at inclusion (Month1 to Month5) | |
Secondary | Variation of biomarkers of stress after the end of the interventional phase. | Evaluate the effectiveness of an individualized thermal intervention on biomarkers of stress among working people. | at inclusion (Month1 to Month5) | |
Secondary | Variation of cardiovascular risk after the end of the interventional phase. | Evaluate the effectiveness of an individualized thermal intervention on cardiovascular risk among working people. | at inclusion (Month1 to Month5) | |
Secondary | Genetic polymorphisms related to stress | effectiveness of an individualized thermal intervention on genetic polymorphisms related to stress. | at inclusion (Month1 to Month5) | |
Secondary | Demographics information | Demographics information will be obtained via a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events | at inclusion (Month1 to Month5) | |
Secondary | Variation of health factors risks after the interventional phase | Evaluate the effectiveness of an individualized thermal intervention on health factors. | at inclusion (Month1 to Month5) | |
Secondary | Variation of body composition after the interventional phase | Evaluate the effectiveness of an individualized thermal intervention on body composition. | at inclusion (Month1 to Month5) | |
Secondary | Variation of subjective stress measures after the interventional phase | Evaluate the effectiveness of an individualized thermal intervention on subjective stress measures. | at inclusion (Month1 to Month5) | |
Secondary | Variation of health biomarkers after the interventional phase | Evaluate the effectiveness of an individualized thermal intervention on Health-related risk assessed by biomarkers. | at inclusion (Month1 to Month5) |
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