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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 (ThermStress)

Primary Purpose

Stress, Burn Out, Heart Rate Variability

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
6 days spa residential program
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress focused on measuring prevention, biomarkers, stress, burn out, occupation, work, spa bath

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Genetic polymorphisms related to stress
effectiveness of an individualized thermal intervention on genetic polymorphisms related to stress.
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
Variation of health factors risks after the interventional phase
Evaluate the effectiveness of an individualized thermal intervention on health factors.
Variation of body composition after the interventional phase
Evaluate the effectiveness of an individualized thermal intervention on body composition.
Variation of subjective stress measures after the interventional phase
Evaluate the effectiveness of an individualized thermal intervention on subjective stress measures.
Variation of health biomarkers after the interventional phase
Evaluate the effectiveness of an individualized thermal intervention on Health-related risk assessed by biomarkers.

Full Information

First Posted
March 26, 2018
Last Updated
May 14, 2018
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Regional Council of Auvergne-Rhône-Alpes, European Regional Development Fund, Spa resort of Néris-les-Bains, SEMETT, 6 place des Thermes, 03310 Néris-les-Bains, France, Université d'Auvergne, LaPEC laboratory (EA 4278), Avignon University, Avignon, France, Innovatherm, EIPAS
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1. Study Identification

Unique Protocol Identification Number
NCT03536624
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Regional Council of Auvergne-Rhône-Alpes, European Regional Development Fund, Spa resort of Néris-les-Bains, SEMETT, 6 place des Thermes, 03310 Néris-les-Bains, France, Université d'Auvergne, LaPEC laboratory (EA 4278), Avignon University, Avignon, France, Innovatherm, EIPAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Burn Out, Heart Rate Variability
Keywords
prevention, biomarkers, stress, burn out, occupation, work, spa bath

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
no masking
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
6 days spa residential program
Intervention Description
6 days spa residential program combining psychological intervention, physical activity, thermal spa treatment, health education and corrections of eating disorders.
Primary Outcome Measure Information:
Title
heart rate variability
Description
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
Time Frame
at inclusion (Month1 to Month5)
Secondary Outcome Measure Information:
Title
Variation of biomarkers of stress after the end of the interventional phase.
Description
Evaluate the effectiveness of an individualized thermal intervention on biomarkers of stress among working people.
Time Frame
at inclusion (Month1 to Month5)
Title
Variation of cardiovascular risk after the end of the interventional phase.
Description
Evaluate the effectiveness of an individualized thermal intervention on cardiovascular risk among working people.
Time Frame
at inclusion (Month1 to Month5)
Title
Genetic polymorphisms related to stress
Description
effectiveness of an individualized thermal intervention on genetic polymorphisms related to stress.
Time Frame
at inclusion (Month1 to Month5)
Title
Demographics information
Description
Demographics information will be obtained via a single questionnaire including questions on age, gender, qualification, personal work status, ethnicity, life and occupational events
Time Frame
at inclusion (Month1 to Month5)
Title
Variation of health factors risks after the interventional phase
Description
Evaluate the effectiveness of an individualized thermal intervention on health factors.
Time Frame
at inclusion (Month1 to Month5)
Title
Variation of body composition after the interventional phase
Description
Evaluate the effectiveness of an individualized thermal intervention on body composition.
Time Frame
at inclusion (Month1 to Month5)
Title
Variation of subjective stress measures after the interventional phase
Description
Evaluate the effectiveness of an individualized thermal intervention on subjective stress measures.
Time Frame
at inclusion (Month1 to Month5)
Title
Variation of health biomarkers after the interventional phase
Description
Evaluate the effectiveness of an individualized thermal intervention on Health-related risk assessed by biomarkers.
Time Frame
at inclusion (Month1 to Month5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederic DUTHEIL
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Frederic DUTHEIL

12. IPD Sharing Statement

Learn more about this trial

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

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