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
NCT ID: NCT03536624
Last Updated: 2018-05-24
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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2017-03-01
2021-03-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Experimental group
Participants will be involved in a short-term spa residential program of 6 days combining psychological intervention, physical activity, thermal spa treatment, health education and corrections of eating disorders.
After the program, participants will be followed for 12 months.
6 days spa residential program
6 days spa residential program combining psychological intervention, physical activity, thermal spa treatment, health education and corrections of eating disorders.
Interventions
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6 days spa residential program
6 days spa residential program combining psychological intervention, physical activity, thermal spa treatment, health education and corrections of eating disorders.
Eligibility Criteria
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Inclusion Criteria
* from 18 years to retirement
* written informed consent
* Affiliation to French health care system (for France)
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Regional Council of Auvergne-Rhône-Alpes
OTHER
European Regional Development Fund
OTHER
Spa resort of Néris-les-Bains, SEMETT, 6 place des Thermes, 03310 Néris-les-Bains, France
UNKNOWN
Université d'Auvergne
OTHER
LaPEC laboratory (EA 4278), Avignon University, Avignon, France
UNKNOWN
Innovatherm
INDUSTRY
EIPAS
OTHER
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Frederic DUTHEIL
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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CHU Clermont-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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2016 A02082 49
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-386
Identifier Type: -
Identifier Source: org_study_id
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