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JOB STRESS in OPHthalmology Physicians and Residents

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04959838
Acronym
JOBSTRESS-OPH
Enrollment
30
Registered
2021-07-13
Start date
2021-07-06
Completion date
2027-07-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Rate Variability, Stress

Keywords

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

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.

Interventions

BEHAVIORALImpact 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.

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variabilityDuring 34 hours in the five different conditionsHRV will be explored in time and frequency domains Abrupt changes in HRV signals will be explored.

Secondary

MeasureTime frameDescription
change in stress levelsat 8am, beginning of the 34 hours follow-up, in the five different conditionsmeasure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in fatigue levelsat 8am, beginning of the 34 hours follow-up, in the five different conditionsmeasure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in burnout levelsat 8am, beginning of the 34 hours follow-up, in the five different conditionsmeasure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in depression levelsat 8am, beginning of the 34 hours follow-up, in the five different conditionsmeasure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in anxiety levelsat 8am, beginning of the 34 hours follow-up, in the five different conditionsmeasure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in "Job demand control support" levelsat 8am, beginning of the 34 hours follow-up, in the five different conditionsmeasure 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.
change in "Effort reward imbalance" levelsat 8am, beginning of the 34 hours follow-up, in the five different conditionsmeasure of effort reward imbalance using visual analogue scale of 100 mm, from 0 to 100. Higher scores of mean a better outcome level.
change in work addiction levelsat 8am, beginning of the 34 hours follow-up, in the five different conditionsmeasure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in sleep qualityat 8am, beginning of the 34 hours follow-up, in the five different conditionsmeasure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Saliva biomarkers cortisolbaseline of the 34 hours procedure, in the five different conditionsmeasure on Cortisol
Saliva biomarkers dheasbaseline of the 34 hours procedure, in the five different conditionsmeasure on dheas
Saliva biomarkers lgAsbaseline of the 34 hours procedure, in the five different conditionsmeasure on lgAs
Saliva biomarkers Leptinebaseline of the 34 hours procedure, in the five different conditionsmeasure on Leptine
Saliva biomarkers Ghrelinbaseline of the 34 hours procedure, in the five different conditionsmeasure on Ghrelin
Declared level of physical activityonce at 8am, at the beginning of the procedurePhysical activity is assessed with one question
Level of physical activityduring 34 hours, in the five different conditionsPhysical activity is assessed with a 3-Axis accelerometer
Level of sedentaryonce at 8am, at the beginning of the procedureSedentary is assessed regarding the time spent sitting assessed with one question
Food intake34 hours recording, in the five different conditionsassessing food intake with ingesta
Sick leaveonce at 8am, at the beginning of the procedureassessing the number of absence days the previous 6 months using a questionnaire
Heightonce at 8am, at the beginning of the proceduremeasure of height in cm using a questionnaire
Weightonce at 8am, at the beginning of the proceduremeasure of weight in kilograms using a questionnaire
Ageonce at 8am, at the beginning of the proceduremeasure of age in years using a questionnaire
Genderonce at 8am, at the beginning of the proceduremeasure of gender using a questionnaire
Qualificationonce at 8am, at the beginning of the proceduremeasure of qualification using a questionnaire
Personal statusonce at 8amat the beginning of the proceduremeasure of personal status using a questionnaire
Lifestyleonce at 8am, at the beginning of the procedureAssessing factors related to lifestyle as smoking, alcohol and coffee consumption using a questionnaire
Skin conductanceduring 34 hours , in the five different conditionsmeasure of the skin conductance using Wrist band electrodes
Sleep qualitymeasure for about 7 hours the night of the control day (no work)measure of sleep quality using Sleep profiler
Surgical performanceOnce at 6pm, at the end of the 34 hours follow-up , in the five different conditionsassessing surgical performance using a high-end virtual reality simulator for intraocular surgery training

Countries

France

Contacts

CONTACTLise Laclautre
promo_interne_drci@chu-clermontferrand.fr334.73.754.963
PRINCIPAL_INVESTIGATORFrédéric DUTHEIL

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026