JOB STRESS in OPHthalmology Physicians and Residents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stress, Heart Rate Variability

Intervention / Treatment
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* Behavioral: Impact of prolonged work


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ophthalmology physicians and residents<br>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. | Behavioral: Impact of prolonged work<br>* Evaluate the impact of prolonged work (up to 60 consecutive hours) on the surgical capacities evaluated on a simulator, as well as on stress markers (questionnaires, saliva assays, skin conductance, quality of sleep) compared to a standard day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | HRV will be explored in time and frequency domains Abrupt changes in HRV signals will be explored. | During 34 hours in the five different conditions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in stress levels | measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 8am, beginning of the 34 hours follow-up, in the five different conditions | 
| change in stress levels | measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 6pm, end of the 34 hours follow-up, in the five different conditions | 
| change in fatigue levels | measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 8am, beginning of the 34 hours follow-up, in the five different conditions | 
| change in fatigue levels | measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 6pm, end of the 34 hours follow-up, in the five different conditions | 
| change in burnout levels | measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 8am, beginning of the 34 hours follow-up, in the five different conditions | 
| change in burnout levels | measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 6pm, end of the 34 hours follow-up, in the five different conditions | 
| change in depression levels | measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 8am, beginning of the 34 hours follow-up, in the five different conditions | 
| change in depression levels | measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 6pm, end of the 34 hours follow-up, in the five different conditions | 
| change in anxiety levels | measure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 8am, beginning of the 34 hours follow-up, in the five different conditions | 
| change in anxiety levels | measure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 6pm, end of the 34 hours follow-up, in the five different conditions | 
| change in Job demand control support levels | measure of job demand, job control and support levels using visual analogue scale of 100 mm, from 0 to 100. Higher scores of demand mean a worse level. Higher scores of control and support mean a better level. | at 8am, beginning of the 34 hours follow-up, in the five different conditions | 
| change in Job demand control support levels | measure of job demand, job control and support levels using visual analogue scale of 100 mm, from 0 to 100. Higher scores of demand mean a worse level. Higher scores of control and support mean a better level. | at 6pm, end of the 34 hours follow-up, in the five different conditions | 
| change in Effort reward imbalance levels | measure of effort reward imbalance using visual analogue scale of 100 mm, from 0 to 100. Higher scores of mean a better outcome level. | at 8am, beginning of the 34 hours follow-up, in the five different conditions | 
| change in Effort reward imbalance levels | measure of effort reward imbalance using visual analogue scale of 100 mm, from 0 to 100. Higher scores of mean a better outcome level. | at 6pm, end of the 34 hours follow-up, in the five different conditions | 
| change in work addiction levels | measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 8am, beginning of the 34 hours follow-up, in the five different conditions | 
| change in work addiction levels | measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 6pm, end of the 34 hours follow-up, in the five different conditions | 
| change in sleep quality | measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 8am, beginning of the 34 hours follow-up, in the five different conditions | 
| change in sleep quality | measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level. | at 6pm, end of the 34 hours follow-up, in the five different conditions | 
| Saliva biomarkers cortisol | measure on Cortisol | baseline of the 34 hours procedure, in the five different conditions | 
| Saliva biomarkers cortisol | measure on Cortisol | 24hours after the beginning of the procedure, in the five different conditions | 
| Saliva biomarkers dheas | measure on dheas | baseline of the 34 hours procedure, in the five different conditions | 
| Saliva biomarkers dheas | measure on dheas | 24 hours after the beginning of the procedure, in the five different conditions | 
| Saliva biomarkers lgAs | measure on lgAs | baseline of the 34 hours procedure, in the five different conditions | 
| Saliva biomarkers lgAs | measure on lgAs | 24 hours after the beginning of the procedure, in the five different conditions | 
| Saliva biomarkers Leptine | measure on Leptine | baseline of the 34 hours procedure, in the five different conditions | 
| Saliva biomarkers Leptine | measure on Leptine | 24 hours after the beginning of the procedure, in the five different conditions | 
| Saliva biomarkers Ghrelin | measure on Ghrelin | baseline of the 34 hours procedure, in the five different conditions | 
| Saliva biomarkers Ghrelin | measure on Ghrelin | 24 hours after the beginning of the procedure, in the five different conditions | 
| Declared level of physical activity | Physical activity is assessed with one question | once at 8am, at the beginning of the procedure | 
| Level of physical activity | Physical activity is assessed with a 3-Axis accelerometer | during 34 hours, in the five different conditions | 
| Level of sedentary | Sedentary is assessed regarding the time spent sitting assessed with one question | once at 8am, at the beginning of the procedure | 
| Food intake | assessing food intake with ingesta | 34 hours recording, in the five different conditions | 
| Sick leave | assessing the number of absence days the previous 6 months using a questionnaire | once at 8am, at the beginning of the procedure | 
| Height | measure of height in cm using a questionnaire | once at 8am, at the beginning of the procedure | 
| Weight | measure of weight in kilograms using a questionnaire | once at 8am, at the beginning of the procedure | 
| Age | measure of age in years using a questionnaire | once at 8am, at the beginning of the procedure | 
| Gender | measure of gender using a questionnaire | once at 8am, at the beginning of the procedure | 
| Qualification | measure of qualification using a questionnaire | once at 8am, at the beginning of the procedure | 
| Personal status | measure of personal status using a questionnaire | once at 8amat the beginning of the procedure | 
| Lifestyle | Assessing factors related to lifestyle as smoking, alcohol and coffee consumption using a questionnaire | once at 8am, at the beginning of the procedure | 
| Skin conductance | measure of the skin conductance using Wrist band electrodes | during 34 hours , in the five different conditions | 
| Sleep quality | measure of sleep quality using Sleep profiler | measure for about 7 hours the night of the control day (no work) | 
| Sleep quality | measure of sleep quality using Sleep profiler | measure for about 7 hours during the night of the typical working day | 
| Surgical performance | assessing surgical performance using a high-end virtual reality simulator for intraocular surgery training | Once at 6pm, at the end of the 34 hours follow-up , in the five different conditions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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questionnaires, ophthalmologists, on-call duty, stress, surgical simulator, heart rate variability, sleep, actimetry