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

Stress Clinical Trial

— ThermStress  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536624
• Other study ID #: CHU-386
• Secondary ID: 2016 A02082 49
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Burn Out
• Burns
• Heart Rate Variability
• Stress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (8)

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

Country where clinical trial is conducted

France, 

Outcome

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)