StressThermStressNCT03536624
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
A study testing 6 days spa residential program in people with Stress and Burn Out, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Burn Out, Heart Rate Variability
- What is being tested?
- 6 days spa residential program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2017to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Participant refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Frederic DUTHEIL
About this 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.
Read the 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.
- Conditions
- Stress, Burn Out, Heart Rate Variability
- Being tested
- 6 days spa residential program
- Keywords
- prevention, biomarkers, stress, burn out, occupation, work, spa bath
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 days spa residential programBehavioural
6 days spa residential program combining psychological intervention, physical activity, thermal spa treatment, health education and corrections of eating disorders.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: 6 days spa residential program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at inclusion (Month1 to Month5)
Secondary outcomes (8)
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.
Measured: at inclusion (Month1 to Month5)
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.
Measured: at inclusion (Month1 to Month5)
Genetic polymorphisms related to stress
effectiveness of an individualized thermal intervention on genetic polymorphisms related to stress.
Measured: at inclusion (Month1 to Month5)
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
Measured: at inclusion (Month1 to Month5)
Variation of health factors risks after the interventional phase
Evaluate the effectiveness of an individualized thermal intervention on health factors.
Measured: at inclusion (Month1 to Month5)
Variation of body composition after the interventional phase
Evaluate the effectiveness of an individualized thermal intervention on body composition.
Measured: at inclusion (Month1 to Month5)
Variation of subjective stress measures after the interventional phase
Evaluate the effectiveness of an individualized thermal intervention on subjective stress measures.
Measured: at inclusion (Month1 to Month5)
Variation of health biomarkers after the interventional phase
Evaluate the effectiveness of an individualized thermal intervention on Health-related risk assessed by biomarkers.
Measured: at inclusion (Month1 to Month5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Mar 2017
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Frederic DUTHEIL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536624
- Sponsor's protocol ID
- CHU-386
- Other IDs
- 2016 A02082 49
- Acronym
- ThermStress
- Status last verified
- May 2018
- First submitted
- 26 Mar 2018
- Last updated
- 24 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03536624
- Acronym / sponsor ID
- ThermStress / CHU-386
- Conditions
- Stress, Burn Out, Heart Rate Variability
- Keywords
- prevention, biomarkers, stress, burn out, occupation, work, spa bath
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- 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
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: 6 days spa residential programParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- Participant refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 days spa residential program6 days spa residential program combining psychological intervention, physical activity, thermal spa treatment, health education and corrections of eating disorders. | Behavioural | Experimental group |
Primary outcome
heart rate variability
Time frame: at inclusion (Month1 to Month5)
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
8 secondary outcomes
Variation of biomarkers of stress after the end of the interventional phase.
Time frame: at inclusion (Month1 to Month5)
Variation of cardiovascular risk after the end of the interventional phase.
Time frame: at inclusion (Month1 to Month5)
Genetic polymorphisms related to stress
Time frame: at inclusion (Month1 to Month5)
Demographics information
Time frame: at inclusion (Month1 to Month5)
Variation of health factors risks after the interventional phase
Time frame: at inclusion (Month1 to Month5)
Variation of body composition after the interventional phase
Time frame: at inclusion (Month1 to Month5)
Variation of subjective stress measures after the interventional phase
Time frame: at inclusion (Month1 to Month5)
Variation of health biomarkers after the interventional phase
Time frame: at inclusion (Month1 to Month5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic DUTHEIL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 days spa residential program in people with Stress and Burn Out, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
heart rate variability (time frame: at inclusion (Month1 to Month5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.