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临床试验/NCT04959838
NCT04959838招募中不适用

Monitoring of JOB STRESS Related to Night Shifts in OPHthalmology Physicians and Residents

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年7月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Heart rate variability

研究概览

简要总结

Ophthalmology physicians and residents work under stress conditions during night emergency ophthalmology shifts. Under time pressure, that is a characteristic of the urgency of care, they must use all their cognitive resources to make an accurate diagnosis and to provide accurate decisions, with sometimes surgical emergency acts. In addition, in France, they work at night following by an usual day work, and they can also work 48 consecutive hours during weekends, followed by a work day … i.e. 60 consecutive hours of work … Long working hours with a short recovery time has been demonstrated to be a major factor of stress and fatigue. Even if not demonstrated on ophthalmologists, those working conditions may contribute to symptoms of mental exhaustion and physical fatigue (sleep deprivation), often accompanied by a loss of motivation at work. This may leads to a feeling of loss of time control; stress can also distort the perception of time and leads to hasty actions or delayed decision-making. The combined effects of stress, feelings of loss of time control, and fatigue necessarily have an impact on work performance and work quality, with a high risk of medical error. Moreover, prolonged stress may expose ophthalmologists to a higher risk of multiple diseases, predominantly systemic inflammation and coronary heart disease.

The main hypothesis is that prolonged work (up to 60 consecutive working hours) may impact on HRV, comparatively to a typical working day.

详细描述

The JOBSTRESS.OPH protocol was designed to study the impact of prolonged work (up to 60 consecutive working hours) on HRV, comparatively to a typical working day. Each residents and / or ophthalmology physicians participates up to a maximum of 5 times. Participants wears a heart rate belt and a watch that measures physical activity and skin conductance for 34 hours straight. Participants only wears an EEG monitor while sleeping to assess its quality. At the end of the evaluation session, a simulator test mimicking the successive stages of cataract surgery is performed, as well as the performance of saliva tests. Short quality of life assessment questionnaires are completed at the start and end of the day, supplemented by a general questionnaire completed only once during the study.

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. All statistical tests will be two-sided and p<0.05 will be considered significant. Graphic representations will be complete presentations of results.

Investigators process multivariate physiological series (HRV, SC, biomarkers) in order to build a stress index. For such multivariate physiological series, investigators first use change point analysis on each univariate series in order to get clusters with constant parameters, then investigators use classification algorithm on the constant parameters obtained in first step in order to obtain different classes corresponding to different levels of stress. Eventually, investigators 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
Na
干预模型
Single Group
主要目的
Screening
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

入选标准

  • Ophthalmologists defined as physicians who completed the ophthalmology DES (Specialized studies diploma), as well as ophthalmology residents defined as a resident registered in the ophthalmology DES working during the inclusion period in the ophthalmology department of the university hospital center of Clermont-Ferrand.
  • Ability to give a written informed consent to participate in research.
  • Affiliation to a social security system.
  • Age between 18 and 65 years old

排除标准

  • Participant refusal to participate
  • Children under the age of 18, pregnant and breastfeeding women, protected adults (individuals under guardianship by court order), adults deprived of their liberty.

研究组 & 干预措施

Ophthalmology physicians and residents

Experimental

Ophthalmology physicians and residents will be followed during 34h, from 8 am to 6 pm the following day,in five different conditions:

  • Control day (no work)
  • Typical working day
  • Working day + one night shift
  • Emergency working day + two consecutive night shifts
  • Night shift.

干预措施: Impact of prolonged work (Behavioral)

结局指标

主要结局

Heart rate variability

时间窗: During 34 hours in the five different conditions

HRV will be explored in time and frequency domains Abrupt changes in HRV signals will be explored.

次要结局

  • change in sleep quality(at 6pm, end of the 34 hours follow-up, in the five different conditions)
  • Saliva biomarkers Leptine(24 hours after the beginning of the procedure, in the five different conditions)
  • Saliva biomarkers Ghrelin(24 hours after the beginning of the procedure, in the five different conditions)
  • Level of physical activity(during 34 hours, in the five different conditions)
  • change in work addiction levels(at 6pm, end of the 34 hours follow-up, in the five different conditions)
  • Saliva biomarkers cortisol(24hours after the beginning of the procedure, in the five different conditions)
  • Food intake(34 hours recording, in the five different conditions)
  • change in stress levels(at 6pm, end of the 34 hours follow-up, in the five different conditions)
  • change in fatigue levels(at 6pm, end of the 34 hours follow-up, in the five different conditions)
  • Saliva biomarkers dheas(24 hours after the beginning of the procedure, in the five different conditions)
  • Level of sedentary(once at 8am, at the beginning of the procedure)
  • Age(once at 8am, at the beginning of the procedure)
  • Personal status(once at 8amat the beginning of the procedure)
  • change in depression levels(at 6pm, end of the 34 hours follow-up, in the five different conditions)
  • change in anxiety levels(at 6pm, end of the 34 hours follow-up, in the five different conditions)
  • change in "Effort reward imbalance" levels(at 6pm, end of the 34 hours follow-up, in the five different conditions)
  • Saliva biomarkers lgAs(24 hours after the beginning of the procedure, in the five different conditions)
  • Qualification(once at 8am, at the beginning of the procedure)
  • change in burnout levels(at 6pm, end of the 34 hours follow-up, in the five different conditions)
  • change in "Job demand control support" levels(at 6pm, end of the 34 hours follow-up, in the five different conditions)
  • Weight(once at 8am, at the beginning of the procedure)
  • Lifestyle(once at 8am, at the beginning of the procedure)
  • Surgical performance(Once at 6pm, at the end of the 34 hours follow-up , in the five different conditions)
  • Declared level of physical activity(once at 8am, at the beginning of the procedure)
  • Sick leave(once at 8am, at the beginning of the procedure)
  • Height(once at 8am, at the beginning of the procedure)
  • Gender(once at 8am, at the beginning of the procedure)
  • Skin conductance(during 34 hours , in the five different conditions)
  • Sleep quality(measure for about 7 hours during the night of the typical working day)

研究者

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

研究点 (1)

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