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NCT Number: NCT04959838

JOB STRESS 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.

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Key information

Conditions

Stress Heart Rate Variability

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU clermont-ferrand

Clermont-Ferrand, France

Location status: Recruiting

Location contact

Frédéric DUTHEIL

PRINCIPAL_INVESTIGATOR

Lise Laclautre

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Heart rate variability

    Time frame: During 34 hours in the five different conditions

    HRV will be explored in time and frequency domains Abrupt changes in HRV signals will be explored.

Secondary outcomes

  1. change in stress levels

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

    measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  2. change in stress levels

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

    measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  3. change in fatigue levels

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

    measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  4. change in fatigue levels

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

    measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  5. change in burnout levels

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

    measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  6. change in burnout levels

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

    measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  7. change in depression levels

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

    measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  8. change in depression levels

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

    measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  9. change in anxiety levels

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

    measure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  10. change in anxiety levels

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

    measure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  11. change in "Job demand control support" levels

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

    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.

  12. change in "Job demand control support" levels

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

    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.

  13. change in "Effort reward imbalance" levels

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

    measure of effort reward imbalance using visual analogue scale of 100 mm, from 0 to 100. Higher scores of mean a better outcome level.

  14. change in "Effort reward imbalance" levels

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

    measure of effort reward imbalance using visual analogue scale of 100 mm, from 0 to 100. Higher scores of mean a better outcome level.

  15. change in work addiction levels

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

    measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  16. change in work addiction levels

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

    measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  17. change in sleep quality

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

    measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  18. change in sleep quality

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

    measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.

  19. Saliva biomarkers cortisol

    Time frame: baseline of the 34 hours procedure, in the five different conditions

    measure on Cortisol

  20. Saliva biomarkers cortisol

    Time frame: 24hours after the beginning of the procedure, in the five different conditions

    measure on Cortisol

  21. Saliva biomarkers dheas

    Time frame: baseline of the 34 hours procedure, in the five different conditions

    measure on dheas

  22. Saliva biomarkers dheas

    Time frame: 24 hours after the beginning of the procedure, in the five different conditions

    measure on dheas

  23. Saliva biomarkers lgAs

    Time frame: baseline of the 34 hours procedure, in the five different conditions

    measure on lgAs

  24. Saliva biomarkers lgAs

    Time frame: 24 hours after the beginning of the procedure, in the five different conditions

    measure on lgAs

  25. Saliva biomarkers Leptine

    Time frame: baseline of the 34 hours procedure, in the five different conditions

    measure on Leptine

  26. Saliva biomarkers Leptine

    Time frame: 24 hours after the beginning of the procedure, in the five different conditions

    measure on Leptine

  27. Saliva biomarkers Ghrelin

    Time frame: baseline of the 34 hours procedure, in the five different conditions

    measure on Ghrelin

  28. Saliva biomarkers Ghrelin

    Time frame: 24 hours after the beginning of the procedure, in the five different conditions

    measure on Ghrelin

  29. Declared level of physical activity

    Time frame: once at 8am, at the beginning of the procedure

    Physical activity is assessed with one question

  30. Level of physical activity

    Time frame: during 34 hours, in the five different conditions

    Physical activity is assessed with a 3-Axis accelerometer

  31. Level of sedentary

    Time frame: once at 8am, at the beginning of the procedure

    Sedentary is assessed regarding the time spent sitting assessed with one question

  32. Food intake

    Time frame: 34 hours recording, in the five different conditions

    assessing food intake with ingesta

  33. Sick leave

    Time frame: once at 8am, at the beginning of the procedure

    assessing the number of absence days the previous 6 months using a questionnaire

  34. Height

    Time frame: once at 8am, at the beginning of the procedure

    measure of height in cm using a questionnaire

  35. Weight

    Time frame: once at 8am, at the beginning of the procedure

    measure of weight in kilograms using a questionnaire

  36. Age

    Time frame: once at 8am, at the beginning of the procedure

    measure of age in years using a questionnaire

  37. Gender

    Time frame: once at 8am, at the beginning of the procedure

    measure of gender using a questionnaire

  38. Qualification

    Time frame: once at 8am, at the beginning of the procedure

    measure of qualification using a questionnaire

  39. Personal status

    Time frame: once at 8amat the beginning of the procedure

    measure of personal status using a questionnaire

  40. Lifestyle

    Time frame: once at 8am, at the beginning of the procedure

    Assessing factors related to lifestyle as smoking, alcohol and coffee consumption using a questionnaire

  41. Skin conductance

    Time frame: during 34 hours , in the five different conditions

    measure of the skin conductance using Wrist band electrodes

  42. Sleep quality

    Time frame: measure for about 7 hours the night of the control day (no work)

    measure of sleep quality using Sleep profiler

  43. Sleep quality

    Time frame: measure for about 7 hours during the night of the typical working day

    measure of sleep quality using Sleep profiler

  44. Surgical performance

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

    assessing surgical performance using a high-end virtual reality simulator for intraocular surgery training

Study contacts

Contact information is provided by the study sponsor or research team.

Lise Laclautre

CONTACT

[email protected]

334.73.754.963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

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

Registry information

Official study title

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

Acronym: JOBSTRESS-OPH

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2021
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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