Stress Clinical Trial
Official 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.
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.
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