Clinical trial NCT05425511: WELL-being Improvement Following a SOphrology Intervention in Hospital Staff
Official title: WELL-being Improvement Following a SOphrology Intervention in Hospital Staff
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Related Disorder
Sophrology
Neurolinguistic Programming
Keywords: stress
heart rate variability
well-being
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Clermont Auvergne (UCA)
name: Centre National de la Recherche Scientifique, France
First posted: 2022-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will recruit workers from hospitals who will be randomized in two groups:

* the intervention group will have a longitudinal follow-up of seven months in total (a control period of 1 month, then 6 to 8 sophrology sessions during two months, then a 4-month follow-up)
* the control group will have a differed intervention (longitudinal follow-up of seven months in total beginning by a control period without intervention of 3 months, then 6 to 8 sophrology sessions during two months, then a 2-month follow-up).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Work stress and psychosocial risks are a major public health problem. Health-care workers (HCW) are particularly at risk. Moreover, non-HCW staff of hospitals can also be at risk, with working environment described as the main risk factor. The University Hospital (CHU) of Clermont-Ferrand is one of the 3 CHUs in France with more than 10% absenteeism, and the first CHU for duration of sick leave. The political orientations favor an approach to improve the quality of life at work.

Sophrology is a psychocorporal method used as a therapeutic technique or experienced as a philosophy of life. It is an exclusively verbal and non-tactile method. It combines a set of techniques that will act both on the body and on the mind through breathing exercises, muscle relaxation and mental imagery (or visualization). It allows to find a state of well-being and to activate all physical and psychological potential in order to acquire a better knowledge of oneself. NLP is a set of communication and self-transformation techniques that focuses on reactions rather than the origins of behaviors. NLP associated with sophrology proposes above all to mobilize the resources of the unconscious.

Neurolinguistic programming (NLP) strategies are effective in the improvement in mental (anxiety and depression), physical, and social health, both in the general population, in individuals with social/psychological problems or in patients, both in hospital settings or outside hospital. Similary, sophrology also demonstrated some benefits on symptoms of patients. However, these approaches have never been provided in the workplace for the benefits of workers at risk of stress-related disorders.

This protocol may permit improvements of stress-related outcomes. Putative short-term benefits: This protocol may incidentally detect cardiac disorders. Any abnormality discovered will not be covered by promotor's insurance (our exploratory study cannot lead to such event) and will be supported by health insurance.

In general, the investigators aim to demonstrate the effectiveness of a workplace sophrology / NLP intervention for HCW at risk of stress-related disorders. Stress and well-being will be the target of the intervention, and will be measured both in a subjective (questionnaire) and objective (biomarkers).

Detailed description: Work stress and psychosocial risks are a major public health problem. Health-care workers (HCW) are particularly at risk. Moreover, non-HCW staff of hospitals can also be at risk, with working environment described as the main risk factor. The University Hospital (CHU) of Clermont-Ferrand is one of the 3 CHUs in France with more than 10% absenteeism, and the first CHU for duration of sick leave. The political orientations favor an approach to improve the quality of life at work.

Sophrology is a psychocorporal method used as a therapeutic technique or experienced as a philosophy of life. It is an exclusively verbal and non-tactile method. It combines a set of techniques that will act both on the body and on the mind through breathing exercises, muscle relaxation and mental imagery (or visualization). It allows to find a state of well-being and to activate all physical and psychological potential in order to acquire a better knowledge of oneself. NLP is a set of communication and self-transformation techniques that focuses on reactions rather than the origins of behaviors. NLP associated with sophrology proposes above all to mobilize the resources of the unconscious.

Neurolinguistic programming (NLP) strategies are effective in the improvement in mental (anxiety and depression), physical, and social health, both in the general population, in individuals with social/psychological problems or in patients, both in hospital settings or outside hospital. Similary, sophrology also demonstrated some benefits on symptoms of patients. However, these approaches have never been provided in the workplace for the benefits of workers at risk of stress-related disorders.

This project proposes to evaluate the effects of a NLP and sophrology intervention for HCW, at the workplace. The investigators aim to evaluate both subjective and objective measures of stress.

This protocol may permit improvements of stress-related outcomes. Putative short-term benefits: This protocol may incidentally detect cardiac disorders. Any abnormality discovered will not be covered by promotor's insurance (our exploratory study cannot lead to such event) and will be supported by health insurance.

In general, the investigators aim to demonstrate the effectiveness of a workplace sophrology / NLP intervention for HCW at risk of stress-related disorders. Stress and well-being will be the target of the intervention, and will be measured both in a subjective (questionnaire) and objective (biomarkers).

The main objective is to demonstrate an improved heart rate variability in the intervention group during the period between month 1 (M1) and M3 (sophrology sessions) of the intervention group in comparison with the same control period M1 to M3 of the "deferred intervention" group.

The secondary objectives are to study for the following comparisons ((i) within groups: comparisons between and M0 to M7 by randomization group and (ii) between groups: comparisons at M5 and then between M0 and M7):

* The effects of the intervention on mental, physical and social health.
* The long-term effects of the intervention.
* The relationships between the perception of work and mental, physical and social health.
* The factors of success of the intervention (personality and perception of work, attendance rate, quality of personal practice, etc.)
* The effects on other biomarkers of stress such as other measures of the activity of the autonomic nervous system, DHEAS, cortisol, etc.

The study will be proposed to workers of the University Hospital of Clermont-Ferrand (CHU)) using the mailing list of the staff. Volunteers will send an email with their contact to the address so-well@chu-clermontferrand.fr. A Clinical Research Assistant will contact them back and give them a first quick explanation of the study by phone, and will send them the information letter, so they can read it prior to the inclusion visit. Investigators will undergo the inclusion visits, either physically or by teleconsultation. Investigators will explain to each volunteer, in an exhaustive, clear and adapted manner, the research procedure, the potential benefit and the adverse effects taking into account their specificity (state of health, age, profession, habits and life projects, family environment, etc.) and will answer all questions. They can sign the consent form either during the consultation or later after a reflection period of 8 days. In this case or for teleconsultation, the two signed consent forms will be returned by post or internal mail to the investigator. The investigator will keep one form, and the second form with both signature (investigator and volunteer) will be given to the volunteer at the baseline measure. They will be informed of the possibility, once their consent has been given, to withdraw it at any time.

Statistical analysis will be performed using Stata software (v15, Stata-Corp, College Station, US). Categorical parameters will be described in terms of numbers and frequencies, whereas continuous variables will be expressed as mean and standard deviation or median and \[inter-quartile range\] according to statistical distribution. The normality will be studied using Shapiro-Wilk test. Graphic representations will be complete presentations of results.

Patients will be described and compared between groups at inclusion according to the following variables: compliance with eligibility criteria, epidemiological characteristics, clinical characteristics and characteristics of possible treatments. The baseline comparability of the two groups will be assessed on the main characteristics of the participants and potential factors associated with the primary outcome. A possible difference between the two groups on one of these characteristics will be determined according to clinical considerations and not solely statistical ones.

Intergroup comparisons will be systematically conducted (1) without adjustment and (2) by adjusting for factors whose distribution could be unbalanced between groups.

All statistical tests will be two-sided and p\<0.05 will be considered significant. Most of analyses of the secondary evaluation criteria will be exploratory. As discussed by Feise, the adjustment of the type I error will not be systematically proposed, but case by case in view of clinical considerations and not only statistical.

This study aims to demonstrate an improved heart rate variability in the intervention group, in comparison with the control group. According to previous data, it seems reasonable to estimate that effect-size, for the primary analysis between M1 and M3, will be around 0.5 for HRV parameters (e.g. log(lf/hf), rmssd, sdnn, pnn50). To highlight such clinically relevant difference, 85 participants per randomized group will be needed for a two-sided type I error at 5%, a statistical power at 90%. Finally, it is proposed to include 100 patients per group to consider lost to follow-up.

Eligibility criteria: Inclusion Criteria:

* worker (HCW or NHCW) from a hospital,
* age between 18-65 years,
* with a stress greater than 50 on a visual analogue scale (VAS) of stress,
* person able to give an informed consent to participate in research and
* affiliated with a Social Security scheme

Exclusion Criteria:

* Psychiatric, cardiovascular (heart failure, arrhythmia, etc.), hepatic (liver failure, etc.), renal (kidney failure, etc.), or endocrinological diseases (diabetes, etc.) judged by the investigator to be incompatible with the study because they may interfere with the measurements
* Non-affiliated to a health insurance
* Protected persons (minors, pregnant women, breastfeeding women, guardianship, curatorship, deprived of freedoms, safeguard of justice)
* Refusal to participate

Primary outcomes:
measure: heart rate variability (HRV) Description : Abrupt changes in HRV signals will be explored. Time Frame : During 34 hours in five different conditions
timeFrame: Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
measure: heart rate variability (HRV) Description : Abrupt changes in HRV signals will be explored. Time Frame : During 34 hours in five different conditions
timeFrame: Once per month during 6 months
Secondary outcomes:
measure: Skin conductance
timeFrame: Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
measure: Skin conductance
timeFrame: Once per month during 6 months
measure: Demographics variables
timeFrame: Once at inclusion
measure: Clinical measurements (height)
timeFrame: Once at inclusion
measure: Clinical measurements (weight)
timeFrame: Once at inclusion
measure: Psychology and quality of life (depression)
timeFrame: 5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
measure: Psychology and quality of life (anxiety)
timeFrame: 5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
measure: Psychology and quality of life (burn-out)
timeFrame: 5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
measure: Psychology and quality of life (perception of work)
timeFrame: 5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
measure: Psychology and quality of life (alexithymia)
timeFrame: 5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
measure: Psychology and quality of life (VAS stress at home)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS stress at work)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS fatigue)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS sleep quality)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS anxiety)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS mood)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS family support)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS hierarchy support)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS colleagues support)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS burnout)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS job control)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS job demand)
timeFrame: Once per week during the whole protocol (8 month)
measure: Psychology and quality of life (VAS effort reward imbalance)
timeFrame: Once per week during the whole protocol (8 month)
measure: Lifestyle (coffee, tea and food intakes)
timeFrame: Once per week during the whole protocol (8 month)
measure: Lifestyle (physical activity)
timeFrame: Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
measure: Lifestyle (physical activity)
timeFrame: Once per month during 6 months
measure: Lifestyle (physical activity)
timeFrame: Once per week during the whole protocol (8 month)
measure: Lifestyle (alcohol, tobacco, cannabis and medication)
timeFrame: Once per week during the whole protocol (8 month)
measure: Sophrology practice (number of sessions per week)
timeFrame: Once per week during the whole protocol (8 month)
measure: Stress before the last sophrology session
timeFrame: Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
measure: Stress after the last sophrology session
timeFrame: Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
measure: Allostatic load (cortisol)
timeFrame: Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
measure: Allostatic load (cortisol)
timeFrame: Once per month during 6 months
measure: Allostatic load (DHEAS)
timeFrame: Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
measure: Allostatic load (DHEAS)
timeFrame: Once per month during 6 months
measure: Allostatic load (leptin)
timeFrame: Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
measure: Allostatic load (leptin)
timeFrame: Once per month during 6 months
measure: Allostatic load (ghrelin)
timeFrame: Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
measure: Allostatic load (ghrelin)
timeFrame: Once per month during 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric Dutheil
role: PRINCIPAL_INVESTIGATOR
References: