Clinical trial NCT04959838: JOB STRESS in OPHthalmology Physicians and Residents
Official title: Monitoring of JOB STRESS Related to Night Shifts in OPHthalmology Physicians and Residents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Heart Rate Variability
Keywords: ophthalmologists
on-call duty
stress
surgical simulator
heart rate variability
sleep
questionnaires
actimetry
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Clermont Auvergne (UCA), Clermont-Ferrand, France
name: LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France
First posted: 2021-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heart rate variability
timeFrame: During 34 hours in the five different conditions
Secondary outcomes:
measure: change in stress levels
timeFrame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
measure: change in stress levels
timeFrame: at 6pm, end of the 34 hours follow-up, in the five different conditions
measure: change in fatigue levels
timeFrame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
measure: change in fatigue levels
timeFrame: at 6pm, end of the 34 hours follow-up, in the five different conditions
measure: change in burnout levels
timeFrame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
measure: change in burnout levels
timeFrame: at 6pm, end of the 34 hours follow-up, in the five different conditions
measure: change in depression levels
timeFrame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
measure: change in depression levels
timeFrame: at 6pm, end of the 34 hours follow-up, in the five different conditions
measure: change in anxiety levels
timeFrame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
measure: change in anxiety levels
timeFrame: at 6pm, end of the 34 hours follow-up, in the five different conditions
measure: change in "Job demand control support" levels
timeFrame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
measure: change in "Job demand control support" levels
timeFrame: at 6pm, end of the 34 hours follow-up, in the five different conditions
measure: change in "Effort reward imbalance" levels
timeFrame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
measure: change in "Effort reward imbalance" levels
timeFrame: at 6pm, end of the 34 hours follow-up, in the five different conditions
measure: change in work addiction levels
timeFrame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
measure: change in work addiction levels
timeFrame: at 6pm, end of the 34 hours follow-up, in the five different conditions
measure: change in sleep quality
timeFrame: at 8am, beginning of the 34 hours follow-up, in the five different conditions
measure: change in sleep quality
timeFrame: at 6pm, end of the 34 hours follow-up, in the five different conditions
measure: Saliva biomarkers cortisol
timeFrame: baseline of the 34 hours procedure, in the five different conditions
measure: Saliva biomarkers cortisol
timeFrame: 24hours after the beginning of the procedure, in the five different conditions
measure: Saliva biomarkers dheas
timeFrame: baseline of the 34 hours procedure, in the five different conditions
measure: Saliva biomarkers dheas
timeFrame: 24 hours after the beginning of the procedure, in the five different conditions
measure: Saliva biomarkers lgAs
timeFrame: baseline of the 34 hours procedure, in the five different conditions
measure: Saliva biomarkers lgAs
timeFrame: 24 hours after the beginning of the procedure, in the five different conditions
measure: Saliva biomarkers Leptine
timeFrame: baseline of the 34 hours procedure, in the five different conditions
measure: Saliva biomarkers Leptine
timeFrame: 24 hours after the beginning of the procedure, in the five different conditions
measure: Saliva biomarkers Ghrelin
timeFrame: baseline of the 34 hours procedure, in the five different conditions
measure: Saliva biomarkers Ghrelin
timeFrame: 24 hours after the beginning of the procedure, in the five different conditions
measure: Declared level of physical activity
timeFrame: once at 8am, at the beginning of the procedure
measure: Level of physical activity
timeFrame: during 34 hours, in the five different conditions
measure: Level of sedentary
timeFrame: once at 8am, at the beginning of the procedure
measure: Food intake
timeFrame: 34 hours recording, in the five different conditions
measure: Sick leave
timeFrame: once at 8am, at the beginning of the procedure
measure: Height
timeFrame: once at 8am, at the beginning of the procedure
measure: Weight
timeFrame: once at 8am, at the beginning of the procedure
measure: Age
timeFrame: once at 8am, at the beginning of the procedure
measure: Gender
timeFrame: once at 8am, at the beginning of the procedure
measure: Qualification
timeFrame: once at 8am, at the beginning of the procedure
measure: Personal status
timeFrame: once at 8amat the beginning of the procedure
measure: Lifestyle
timeFrame: once at 8am, at the beginning of the procedure
measure: Skin conductance
timeFrame: during 34 hours , in the five different conditions
measure: Sleep quality
timeFrame: measure for about 7 hours the night of the control day (no work)
measure: Sleep quality
timeFrame: measure for about 7 hours during the night of the typical working day
measure: Surgical performance
timeFrame: Once at 6pm, at the end of the 34 hours follow-up , in the five different conditions
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric DUTHEIL
role: PRINCIPAL_INVESTIGATOR
References: