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Recruiting NCT04959838

JOB STRESS in OPHthalmology Physicians and Residents

No phase Interventional Stress Heart Rate Variability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Impact of prolonged work.
Who it may be relevant to
Registry conditions: Stress, Heart Rate Variability. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Heart rate variability [Time frame: During 34 hours in the five different conditions]
Secondary outcome measures (12)
  • change in stress levels [Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions]
  • change in stress levels [Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions]
  • change in fatigue levels [Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions]
  • change in fatigue levels [Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions]
  • change in burnout levels [Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions]
  • change in burnout levels [Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions]
  • change in depression levels [Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions]
  • change in depression levels [Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions]
  • change in anxiety levels [Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions]
  • change in anxiety levels [Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions]
  • change in "Job demand control support" levels [Time frame: at 8am, beginning of the 34 hours follow-up, in the five different conditions]
  • change in "Job demand control support" levels [Time frame: at 6pm, end of the 34 hours follow-up, in the five different conditions]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

France · 1 center
  • CHU clermont-ferrand — Clermont-Ferrand

Identifiers

NCT: NCT04959838 · RBHP 2020 DUTHEIL 2 · 2020-A03231-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗