WELL-being Improvement Following a SOphrology Intervention in Hospital Staff

Stress Related Disorder Clinical Trial

— So-Well  

Official title:

WELL-being Improvement Following a SOphrology Intervention in Hospital Staff

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05425511
• Other study ID #: AOI 2020 DUTHEIL
• Secondary ID: 2020-A03236-33
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2023
• Est. completion date: March 2028

Study information

• Verified date: June 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2028
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Related Disorder

Intervention

Behavioral:
• sophrology / neurolinguistic programming intervention
2 sessions will be offered per week at 2 different time and will last 1 hour. They can take place in a seated or standing position, without physical contact. The sessions will consist of breathing exercises, visualization, dynamic relaxation and concentration exercises. The program is standardized: Dialogue between the sophrologist and the participants. It is possible to specify the objective(s) of the session. The sophrologist can ask more specific questions to adapt the session. Presentation of the conduct of the session (possible variations) and instructions promoting autonomy Guided by the sophrologist, the goal is to help free yourself from tensions, to play down a situation that worries and finally to realize that we can deal with. Exercises are adapted to the difficulties encountered by the participants. Time for free expression after the practice to promote the integration of the technique while giving elements to the sophrologist to guide the future sessions.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Centre National de la Recherche Scientifique, France, University Clermont Auvergne (UCA)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate variability (HRV) Description : Abrupt changes in HRV signals will be explored. Time Frame : During 34 hours in five different conditions	HRV will be explored in time and frequency domains using Zephyr™ BioHarness™ BT.	Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Primary	heart rate variability (HRV) Description : Abrupt changes in HRV signals will be explored. Time Frame : During 34 hours in five different conditions	HRV will be explored in time and frequency domains using Zephyr™ BioHarness™ BT.	Once per month during 6 months
Secondary	Skin conductance	Measure using Wristband electrodes - Empatica E4	Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Secondary	Skin conductance	Measure using Wristband electrodes - Empatica E4	Once per month during 6 months
Secondary	Demographics variables	Measure of age, gender, qualification, personal status using a questionnaire	Once at inclusion
Secondary	Clinical measurements (height)	Measure of height using a questionnaire	Once at inclusion
Secondary	Clinical measurements (weight)	Measure of weight using a questionnaire	Once at inclusion
Secondary	Psychology and quality of life (depression)	Measure of depression using HAD 7 items	5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
Secondary	Psychology and quality of life (anxiety)	Measure of anxiety using HAD 7 items	5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
Secondary	Psychology and quality of life (burn-out)	Measure of burn-out using Maslach Burn-Out Inventory	5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
Secondary	Psychology and quality of life (perception of work)	Measure of perception of work using Job Content Questionnaire of Karasek	5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
Secondary	Psychology and quality of life (alexithymia)	Measure of alexithymia using Toronto Alexithymia Scale (TAS-20)	5 times : Month 0, Month 1, Month 3, Month 5 and Month 7
Secondary	Psychology and quality of life (VAS stress at home)	Measure of stress at home using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a worse outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS stress at work)	Measure of stress at work using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a worse outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS fatigue)	Measure of fatigue using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a worse outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS sleep quality)	Measure of sleep quality using visual analog scale of 100 mm ranging from 0 (Bad) ot 100 (Excellent). Higher scores mean a better outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS anxiety)	Measure of anxiety using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a worse outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS mood)	Measure of mood using visual analog scale of 100 mm ranging from 0 (Bad) ot 100 (Excellent). Higher scores mean a better outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS family support)	Measure of family support using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a better outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS hierarchy support)	Measure of hierarchy support using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a better outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS colleagues support)	Measure of colleagues support using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a better outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS burnout)	Measure of burnout using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a worse outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS job control)	Measure of job control using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a better outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS job demand)	Measure of job demand using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a worse outcome	Once per week during the whole protocol (8 month)
Secondary	Psychology and quality of life (VAS effort reward imbalance)	Measure of effort reward imbalance using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a better outcome	Once per week during the whole protocol (8 month)
Secondary	Lifestyle (coffee, tea and food intakes)	Measure of coffee, tea and food intakes using a questionnaire	Once per week during the whole protocol (8 month)
Secondary	Lifestyle (physical activity)	Measure of physical activity using Recent Physical Activity Questionnaire (RAPQ)	Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Secondary	Lifestyle (physical activity)	Measure of physical activity using Recent Physical Activity Questionnaire (RAPQ)	Once per month during 6 months
Secondary	Lifestyle (physical activity)	Measure of physical activity using questionnaire	Once per week during the whole protocol (8 month)
Secondary	Lifestyle (alcohol, tobacco, cannabis and medication)	Measure of consumption of alcohol, tobacco, cannabis and medication using questionnaire	Once per week during the whole protocol (8 month)
Secondary	Sophrology practice (number of sessions per week)	Measure of number of sessions per week using questionnaire	Once per week during the whole protocol (8 month)
Secondary	Stress before the last sophrology session	Measure of stress before the last sophrology session using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a worse outcome	Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Secondary	Stress after the last sophrology session	Measure of stress after the last sophrology session using visual analog scale of 100 mm ranging from 0 (Minimum) ot 100 (Maximum). Higher scores mean a worse outcome	Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Secondary	Allostatic load (cortisol)	Measure of cortisol using saliva sampling (and deep-freezing)	Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Secondary	Allostatic load (cortisol)	Measure of cortisol using saliva sampling (and deep-freezing)	Once per month during 6 months
Secondary	Allostatic load (DHEAS)	Measure of DHEAS using saliva sampling (and deep-freezing)	Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Secondary	Allostatic load (DHEAS)	Measure of DHEAS using saliva sampling (and deep-freezing)	Once per month during 6 months
Secondary	Allostatic load (leptin)	Measure of leptin using saliva sampling (and deep-freezing)	Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Secondary	Allostatic load (leptin)	Measure of leptin using saliva sampling (and deep-freezing)	Once per month during 6 months
Secondary	Allostatic load (ghrelin)	Measure of ghrelin using saliva sampling (and deep-freezing)	Once per session of sophrology (6 to 8 sessions) during the 2 months intervention
Secondary	Allostatic load (ghrelin)	Measure of ghrelinusing saliva sampling (and deep-freezing)	Once per month during 6 months