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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03536624
Acronym
ThermStress
Enrollment
60
Registered
2018-05-24
Start date
2017-03-01
Completion date
2021-03-01
Last updated
2018-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Out, Heart Rate Variability, Stress

Keywords

prevention, biomarkers, stress, burn out, occupation, work, spa bath

Brief summary

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.

Detailed description

The Therm-Stress protocol was designed to provide a better understanding of the effect of a short spa residential program of work-related stress prevention on the improvement of heart rate variability. In the present protocol, parameters are measured on six occasions (inclusion, 6 days before the start, at the start of the spa, at the end of the spa, at 6 months and at 12 months). Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be two-sided and p\<0.05 will be considered significant. After testing for normal distribution (Shapiro-Wilk test), data will be treated either by parametric or non-parametric analyses according to statistical assumptions. Inter-groups comparisons will systematically be performed 1) without adjustment and 2) adjusting on factors liable to be biased between groups. Analysis will be performed using anova or Kruskal-Wallis (KW) tests. When appropriate (p\<0.05), a post-hoc test for multiple comparisons (Tukey-Kramer after anova and Dunn post KW) will be used. Linear regression (with logarithmic transformation if necessary) considering an adjustment on covariates fixed according to epidemiological relevance and observance to physical activity will complete the analysis. Comparisons of categorical variables will be performed using Chi-squared or Fischer test. Marascuillo's procedure will be performed for multiple comparisons. Relations between quantitative outcomes will be analyzed using correlation coefficients (Pearson or Spearman). Fisher's Z transformation and William's T2 statistic will be performed to compare correlations between variables and within a single group of subjects. Longitudinal data will be treated using mixt-model analyses in order to treat fixed effects group, time and group x time interaction taking into account between and within participant variability.

Interventions

BEHAVIORAL6 days spa residential program

6 days spa residential program combining psychological intervention, physical activity, thermal spa treatment, health education and corrections of eating disorders.

Sponsors

Regional Council of Auvergne-Rhône-Alpes
CollaboratorOTHER
European Regional Development Fund
CollaboratorOTHER
Spa resort of Néris-les-Bains, SEMETT, 6 place des Thermes, 03310 Néris-les-Bains, France
CollaboratorUNKNOWN
Université d'Auvergne
CollaboratorOTHER
LaPEC laboratory (EA 4278), Avignon University, Avignon, France
CollaboratorUNKNOWN
Innovatherm
CollaboratorINDUSTRY
EIPAS
CollaboratorOTHER
University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Masking description

no masking

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
heart rate variabilityat inclusion (Month1 to Month5)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

Secondary

MeasureTime frameDescription
Variation of cardiovascular risk after the end of the interventional phase.at inclusion (Month1 to Month5)Evaluate the effectiveness of an individualized thermal intervention on cardiovascular risk among working people.
Genetic polymorphisms related to stressat inclusion (Month1 to Month5)effectiveness of an individualized thermal intervention on genetic polymorphisms related to stress.
Demographics informationat inclusion (Month1 to Month5)Demographics information will be obtained via a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events
Variation of biomarkers of stress after the end of the interventional phase.at inclusion (Month1 to Month5)Evaluate the effectiveness of an individualized thermal intervention on biomarkers of stress among working people.
Variation of body composition after the interventional phaseat inclusion (Month1 to Month5)Evaluate the effectiveness of an individualized thermal intervention on body composition.
Variation of subjective stress measures after the interventional phaseat inclusion (Month1 to Month5)Evaluate the effectiveness of an individualized thermal intervention on subjective stress measures.
Variation of health biomarkers after the interventional phaseat inclusion (Month1 to Month5)Evaluate the effectiveness of an individualized thermal intervention on Health-related risk assessed by biomarkers.
Variation of health factors risks after the interventional phaseat inclusion (Month1 to Month5)Evaluate the effectiveness of an individualized thermal intervention on health factors.

Countries

France

Contacts

Primary ContactPatrick LACARIN
placarin@chu-clermontferrand.fr0473751195

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026