JOB STRESS in OPHthalmology Physicians and Residents

Stress Clinical Trial

— JOBSTRESS-OPH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04959838
• Other study ID #: RBHP 2020 DUTHEIL 2
• Secondary ID: 2020-A03231-38
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: July 2025

Study information

• Verified date: June 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Rate Variability
• Occupational Stress
• Stress

Intervention

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.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France, University Clermont Auvergne (UCA), Clermont-Ferrand, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Saliva biomarkers cortisol	measure on Cortisol	baseline of the 34 hours procedure, in the five different conditions
Secondary	Saliva biomarkers cortisol	measure on Cortisol	24hours after the beginning of the procedure, in the five different conditions
Secondary	Saliva biomarkers dheas	measure on dheas	baseline of the 34 hours procedure, in the five different conditions
Secondary	Saliva biomarkers dheas	measure on dheas	24 hours after the beginning of the procedure, in the five different conditions
Secondary	Saliva biomarkers lgAs	measure on lgAs	baseline of the 34 hours procedure, in the five different conditions
Secondary	Saliva biomarkers lgAs	measure on lgAs	24 hours after the beginning of the procedure, in the five different conditions
Secondary	Saliva biomarkers Leptine	measure on Leptine	baseline of the 34 hours procedure, in the five different conditions
Secondary	Saliva biomarkers Leptine	measure on Leptine	24 hours after the beginning of the procedure, in the five different conditions
Secondary	Saliva biomarkers Ghrelin	measure on Ghrelin	baseline of the 34 hours procedure, in the five different conditions
Secondary	Saliva biomarkers Ghrelin	measure on Ghrelin	24 hours after the beginning of the procedure, in the five different conditions
Secondary	Declared level of physical activity	Physical activity is assessed with one question	once at 8am, at the beginning of the procedure
Secondary	Level of physical activity	Physical activity is assessed with a 3-Axis accelerometer	during 34 hours, in the five different conditions
Secondary	Level of sedentary	Sedentary is assessed regarding the time spent sitting assessed with one question	once at 8am, at the beginning of the procedure
Secondary	Food intake	assessing food intake with ingesta	34 hours recording, in the five different conditions
Secondary	Sick leave	assessing the number of absence days the previous 6 months using a questionnaire	once at 8am, at the beginning of the procedure
Secondary	Height	measure of height in cm using a questionnaire	once at 8am, at the beginning of the procedure
Secondary	Weight	measure of weight in kilograms using a questionnaire	once at 8am, at the beginning of the procedure
Secondary	Age	measure of age in years using a questionnaire	once at 8am, at the beginning of the procedure
Secondary	Gender	measure of gender using a questionnaire	once at 8am, at the beginning of the procedure
Secondary	Qualification	measure of qualification using a questionnaire	once at 8am, at the beginning of the procedure
Secondary	Personal status	measure of personal status using a questionnaire	once at 8amat the beginning of the procedure
Secondary	Lifestyle	Assessing factors related to lifestyle as smoking, alcohol and coffee consumption using a questionnaire	once at 8am, at the beginning of the procedure
Secondary	Skin conductance	measure of the skin conductance using Wrist band electrodes	during 34 hours , in the five different conditions
Secondary	Sleep quality	measure of sleep quality using Sleep profiler	measure for about 7 hours the night of the control day (no work)
Secondary	Sleep quality	measure of sleep quality using Sleep profiler	measure for about 7 hours during the night of the typical working day
Secondary	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