JOB STRESS in OPHthalmology Physicians and Residents

NCT04959838 | Recruiting

• 2 other identifiers: RBHP 2020 DUTHEIL 22020-A03231-38
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Heart Rate Variability

Keywords

ophthalmologists; on-call duty; stress; surgical simulator; heart rate variability; sleep; questionnaires; actimetry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (44)

• change in stress levels

  at 8am, beginning of the 34 hours follow-up, in the five different conditions

• change in stress levels

  at 6pm, end of the 34 hours follow-up, in the five different conditions

• change in fatigue levels

  at 8am, beginning of the 34 hours follow-up, in the five different conditions

• change in fatigue levels

  at 6pm, end of the 34 hours follow-up, in the five different conditions

• change in burnout levels

  at 8am, beginning of the 34 hours follow-up, in the five different conditions

Study Arms (1)

Ophthalmology physicians and residents

EXPERIMENTAL

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

Interventions

Impact of prolonged work 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.

Ophthalmology physicians and residents

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to give a written informed consent to participate in research.
• Affiliation to a social security system.
• Age between 18 and 65 years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• University Clermont Auvergne (UCA), Clermont-Ferrand, France: collaborator
• LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France: collaborator

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

Study Officials

• Frédéric DUTHEIL

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 13, 2021
• Study Start: July 6, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

FR (1)