JOB STRESS in OPHthalmology Physicians and Residents (JOBSTRESS-OPH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Heart Rate Variability
• Intervention / Treatment: Behavioral: Impact of prolonged work

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • Chu Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ophthalmology physicians and residents; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: University Clermont Auvergne (UCA), Clermont-Ferrand, France; LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 13, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: sleep; stress; heart rate variability; surgical simulator; questionnaires; actimetry; ophthalmologists; on-call duty
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Occupational Diseases; Occupational Stress
• Other Study ID Numbers: RBHP 2020 DUTHEIL 2; 2020-A03231-38 (Other Identifier: 2020-A03231-38)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No