JOB STRESS in OPHthalmology Physicians and Residents

NCT ID: NCT04959838

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-06
• Study Completion Date: 2027-07-31

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.

Conditions

Stress; Heart Rate Variability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Impact of prolonged work

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Clermont Auvergne (UCA), Clermont-Ferrand, France

UNKNOWN

Sponsor Role: collaborator

LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric DUTHEIL

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334.73.754.963

Facility Contacts

Lise Laclautre

Role: primary

Other Identifiers

2020-A03231-38

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2020 DUTHEIL 2

Identifier Type: -

Identifier Source: org_study_id