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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2021-03-01

Brief Summary

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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

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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.

Conditions

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Stress Burn Out Heart Rate Variability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

no masking

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.

Group Type EXPERIMENTAL

6 days spa residential program

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regional Council of Auvergne-Rhône-Alpes

OTHER

Sponsor Role collaborator

European Regional Development Fund

OTHER

Sponsor Role collaborator

Spa resort of Néris-les-Bains, SEMETT, 6 place des Thermes, 03310 Néris-les-Bains, France

UNKNOWN

Sponsor Role collaborator

Université d'Auvergne

OTHER

Sponsor Role collaborator

LaPEC laboratory (EA 4278), Avignon University, Avignon, France

UNKNOWN

Sponsor Role collaborator

Innovatherm

INDUSTRY

Sponsor Role collaborator

EIPAS

OTHER

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

0473751195

Facility Contacts

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Patrick LACARIN

Role: primary

0473751195

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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