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

NCT03536624 | Unknown

• 2 other identifiers: CHU-3862016 A02082 49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Burn Out; Heart Rate Variability

Keywords

prevention; biomarkers; stress; burn out; occupation; work; spa bath

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Variation of biomarkers of stress after the end of the interventional phase.

  at inclusion (Month1 to Month5)

• Variation of cardiovascular risk after the end of the interventional phase.

  at inclusion (Month1 to Month5)

• Genetic polymorphisms related to stress

  at inclusion (Month1 to Month5)

• Demographics information

  at inclusion (Month1 to Month5)

• Variation of health factors risks after the interventional phase

  at inclusion (Month1 to Month5)

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Behavioral: 6 days spa residential program

Interventions

6 days spa residential program BEHAVIORAL

6 days spa residential program combining psychological intervention, physical activity, thermal spa treatment, health education and corrections of eating disorders.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Participant refusal to participate

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Regional Council of Auvergne-Rhône-Alpes: collaborator
• European Regional Development Fund: collaborator
• Spa resort of Néris-les-Bains, SEMETT, 6 place des Thermes, 03310 Néris-les-Bains, France: collaborator
• Université d'Auvergne: collaborator
• LaPEC laboratory (EA 4278), Avignon University, Avignon, France: collaborator
• Innovatherm: collaborator
• EIPAS: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Frederic DUTHEIL

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: no masking
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: May 24, 2018
• Study Start: March 1, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 24, 2018

Record last verified: 2018-05

Locations

FR (1)