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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03236-33 | Other Identifier | ANSM |
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Study stopped early for futility after a pre-planned interim analysis of the first 100 participants. The treatment effect met the predefined futility criterion (-0.2 to +0.2), indicating a low likelihood of benefit.
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| Name | Class |
|---|---|
| University Clermont Auvergne (UCA) | UNKNOWN |
| Centre National de la Recherche Scientifique, France | OTHER |
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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).
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | 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). |
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| control group | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sophrology / neurolinguistic programming intervention | Behavioral | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin conductance | Measure using Wristband electrodes - Empatica E4 | Once per session of sophrology (6 to 8 sessions) during the 2 months intervention |
| Skin conductance | Measure using Wristband electrodes - Empatica E4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Dutheil | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU clermont-ferrand | Clermont-Ferrand | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36673939 | Derived | Dutheil F, Parreira LM, Pereira B, Baldet M, Marson F, Chabaud C, Blot M, Baker JS, Zak M, Vallet G, Magnon V, Clinchamps M, Altun S. SOphrology Intervention to Improve WELL-Being in Hospital Staff (SO-WELL): Protocol for a Randomized Controlled Trial Study. Int J Environ Res Public Health. 2023 Jan 9;20(2):1185. doi: 10.3390/ijerph20021185. |
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We will recruit workers from hospitals who will be randomized in two groups:
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| Once per month during 6 months |
| Demographics variables | Measure of age, gender, qualification, personal status using a questionnaire | Once at inclusion |
| Clinical measurements (height) | Measure of height using a questionnaire | Once at inclusion |
| Clinical measurements (weight) | Measure of weight using a questionnaire | Once at inclusion |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
| Lifestyle (physical activity) | Measure of physical activity using Recent Physical Activity Questionnaire (RAPQ) | Once per month during 6 months |
| Lifestyle (physical activity) | Measure of physical activity using questionnaire | Once per week during the whole protocol (8 month) |
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
| Allostatic load (cortisol) | Measure of cortisol using saliva sampling (and deep-freezing) | Once per month during 6 months |
| 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 |
| Allostatic load (DHEAS) | Measure of DHEAS using saliva sampling (and deep-freezing) | Once per month during 6 months |
| 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 |
| Allostatic load (leptin) | Measure of leptin using saliva sampling (and deep-freezing) | Once per month during 6 months |
| 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 |
| Allostatic load (ghrelin) | Measure of ghrelinusing saliva sampling (and deep-freezing) | Once per month during 6 months |