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临床试验/NCT04334083
NCT04334083已完成不适用

Biomarkers Of Job STRess In Emergency Senior Physicians - Detection of Stressful Events

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年2月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
heart rate variability at night work

研究概览

简要总结

Emergency medicine is a unique specialty focusing on a breadth of acute care, on demand . Shift work is also a fundamental component of emergency medicine, and is associated with chronic stress, including stress at work. Consequently, stress may lead to symptoms of mental exhaustion, physical fatigue, detachment from work, and feelings of diminished competence . Emergency physicians (EPs) are exposed to a complex interplay between stress (life-and-death emergencies - a defining characteristic of their job), sleep deprivation, and fatigue due to repeated changes in, and duration of shifts. Work-related exhaustion can lead to various physical and psychological symptoms, and also may be associated with delayed decision-making . The combined effects of stress and fatigue can impact on job performance, often resulting in otherwise preventable medical errors. Moreover, prolonged stress may expose EPs to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease. All these contribute to the premature departure of EPs to other specialties. Furthermore, low HRV has been associated with stress, burnout, and is linked with an increased risk of cardiovascular diseases.

This project proposes to evaluate if life-and-death emergencies or specific situations will induce abrupt changes in HRV among emergency physicians. Moreover, we would like to compare reactions between being an actor (EPs) and being a spectator and assess the role of expertise and habituation to stressful emergency situations.

详细描述

The JOBSTRESS protocol was designed to provide a better understanding of the association between specific situations (ie: life and death emergencies) and breaks in the variability of the heart rate. Each emergency physician participates in the study two times. A night shift from 6:30 p.m to 8:30 a.m (14 hours) which will be compared with a day shift, as a control, from 8:30 a.m to 6:30 p.m. Emergency physicians will be accompanied by a medical externship student.

Statistical analysis will be performed using Stata software (version 13; Stata-Corp, College Station, Tex., USA). All statistical tests will be bilateral and a p <0.05 will be considered significant. Qualitative variables will be described in terms of numbers and proportions. Quantitative variables will be described in terms of numbers, average, median, standard deviation, and range. Graphic representations will be complete presentations of results. We process multivariate physiological series (HR, HRV, SC, wrist motion, respiratory rate) in order to build a stress index. For such multivariate physiological series, we first use change point analysis on each univariate series in order to get clusters with constant parameters, then we use classification algorithm on the constant parameters obtained in first step in order to obtain different classes corresponding to different levels of stress. Eventually, we obtain at each time the level of stress and can compare it to the environmental conditions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Emergency physicians from the emergency department of CHU Clermont-Ferrand will be accompanied by a medical externship student.
  • Ability to give a written informed consent.

排除标准

  • Participant refusal to participate

研究组 & 干预措施

Emergency physicians

Experimental

actors during the work

干预措施: Comparison of biomarkers of stress (Behavioral)

medical externship student

Experimental

spectator during the emergency physician work

干预措施: Comparison of biomarkers of stress (Behavioral)

结局指标

主要结局

heart rate variability at night work

时间窗: from 18:30 to 8:30, during the 14 hours of the night shift

measure of abrupt changes in HRV signals during 14 hours

heart rate variability at day work

时间窗: from 8:30 to 18:30, during the 10 hours of the day shift

measure of abrupt changes in HRV signals during 10 hours

次要结局

  • Fatigue(at 18:30, end of the day shift)
  • Saliva biomarkers DHEAS(at 18:30, end of the day shift)
  • blood samples TG(at 8:30, baseline of the day shift)
  • blood samples DHEAS(at 8:30, baseline of the day shift)
  • blood samples BDNF(at 8:30, baseline of the day shift)
  • blood samples proinflammatory cytokines(at 8:30, baseline of the day shift)
  • Burnout(day 1)
  • Sick leave(day 1)
  • blood samples HDLc and LDL-cholesterol(at 8:30, baseline of the day shift)
  • blood samples Cortisol(at 8:30, baseline of the day shift)
  • blood samples vitamine D(at 8:30, baseline of the day shift)
  • Stress(at 18:30, end of the day shift)
  • Saliva biomarkers cortisol(at 18:30, end of the day shift)
  • blood samples full blood count(at 8:30, baseline of the day shift)
  • blood samples HbA1c,(at 8:30, baseline of the day shift)
  • Saliva biomarkers lgAs(at 18:30, end of the day shift)
  • blood samples telomeres lengh(at 8:30, baseline of the day shift)
  • Anxiety(day 1)
  • Depression(day 1)
  • systolic blood pressure(at 18:30, end of day shift)
  • Life satisfaction(day 1)
  • Lifestyle(day 1)
  • Clinical measurements weight(day 1)
  • Clinical measurements height(day 1)
  • Life and occupational events(day 1)
  • diastolic blood pressure(at 18:30, end of day shift)
  • skin conductance(from 8:30 to 18:30, during the 10 hours of day shift)
  • Genetic factors ACE(at 8:30, baseline of the day shift)
  • Genetic factors (5-HTT)(at 8:30, baseline of the day shift)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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