WELL-being Improvement Following a SOphrology Intervention in Hospital Staff
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 103
- 试验地点
- 3
- 主要终点
- heart rate variability (HRV) Description : Abrupt changes in HRV signals will be explored. Time Frame : During 34 hours in five different conditions
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
intervention group
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).
干预措施: sophrology / neurolinguistic programming intervention (Behavioral)
control group
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).
干预措施: sophrology / neurolinguistic programming intervention (Behavioral)
结局指标
主要结局
heart rate variability (HRV) Description : Abrupt changes in HRV signals will be explored. Time Frame : During 34 hours in five different conditions
时间窗: Once per month during 6 months
HRV will be explored in time and frequency domains using Zephyr™ BioHarness™ BT.
次要结局
- Psychology and quality of life (depression)(5 times : Month 0, Month 1, Month 3, Month 5 and Month 7)
- Psychology and quality of life (burn-out)(5 times : Month 0, Month 1, Month 3, Month 5 and Month 7)
- Psychology and quality of life (alexithymia)(5 times : Month 0, Month 1, Month 3, Month 5 and Month 7)
- Psychology and quality of life (VAS stress at home)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS sleep quality)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS anxiety)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS job control)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS job demand)(Once per week during the whole protocol (8 month))
- Skin conductance(Once per month during 6 months)
- Demographics variables(Once at inclusion)
- Clinical measurements (height)(Once at inclusion)
- Clinical measurements (weight)(Once at inclusion)
- Psychology and quality of life (anxiety)(5 times : Month 0, Month 1, Month 3, Month 5 and Month 7)
- Psychology and quality of life (VAS fatigue)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS colleagues support)(Once per week during the whole protocol (8 month))
- Lifestyle (physical activity)(Once per week during the whole protocol (8 month))
- Allostatic load (leptin)(Once per month during 6 months)
- Psychology and quality of life (perception of work)(5 times : Month 0, Month 1, Month 3, Month 5 and Month 7)
- Psychology and quality of life (VAS stress at work)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS mood)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS family support)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS hierarchy support)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS burnout)(Once per week during the whole protocol (8 month))
- Psychology and quality of life (VAS effort reward imbalance)(Once per week during the whole protocol (8 month))
- Lifestyle (coffee, tea and food intakes)(Once per week during the whole protocol (8 month))
- Lifestyle (alcohol, tobacco, cannabis and medication)(Once per week during the whole protocol (8 month))
- Sophrology practice (number of sessions per week)(Once per week during the whole protocol (8 month))
- Stress before the last sophrology session(Once per session of sophrology (6 to 8 sessions) during the 2 months intervention)
- Stress after the last sophrology session(Once per session of sophrology (6 to 8 sessions) during the 2 months intervention)
- Allostatic load (cortisol)(Once per month during 6 months)
- Allostatic load (DHEAS)(Once per month during 6 months)
- Allostatic load (ghrelin)(Once per month during 6 months)