search
Back to results

JOB STRESS in OPHthalmology Physicians and Residents (JOBSTRESS-OPH)

Primary Purpose

Stress, Heart Rate Variability

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Impact of prolonged work
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Stress focused on measuring ophthalmologists, on-call duty, stress, surgical simulator, heart rate variability, sleep, questionnaires, actimetry

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU clermont-ferrandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ophthalmology physicians and residents

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

change in stress levels
measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in stress levels
measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in fatigue levels
measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in fatigue levels
measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in burnout levels
measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in burnout levels
measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in depression levels
measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in depression levels
measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in anxiety levels
measure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in anxiety levels
measure 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" levels
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.
change in "Job demand control support" levels
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.
change in "Effort reward imbalance" levels
measure 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 "Effort reward imbalance" levels
measure 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 levels
measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in work addiction levels
measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in sleep quality
measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
change in sleep quality
measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Saliva biomarkers cortisol
measure on Cortisol
Saliva biomarkers cortisol
measure on Cortisol
Saliva biomarkers dheas
measure on dheas
Saliva biomarkers dheas
measure on dheas
Saliva biomarkers lgAs
measure on lgAs
Saliva biomarkers lgAs
measure on lgAs
Saliva biomarkers Leptine
measure on Leptine
Saliva biomarkers Leptine
measure on Leptine
Saliva biomarkers Ghrelin
measure on Ghrelin
Saliva biomarkers Ghrelin
measure on Ghrelin
Declared level of physical activity
Physical activity is assessed with one question
Level of physical activity
Physical activity is assessed with a 3-Axis accelerometer
Level of sedentary
Sedentary is assessed regarding the time spent sitting assessed with one question
Food intake
assessing food intake with ingesta
Sick leave
assessing the number of absence days the previous 6 months using a questionnaire
Height
measure of height in cm using a questionnaire
Weight
measure of weight in kilograms using a questionnaire
Age
measure of age in years using a questionnaire
Gender
measure of gender using a questionnaire
Qualification
measure of qualification using a questionnaire
Personal status
measure of personal status using a questionnaire
Lifestyle
Assessing factors related to lifestyle as smoking, alcohol and coffee consumption using a questionnaire
Skin conductance
measure of the skin conductance using Wrist band electrodes
Sleep quality
measure of sleep quality using Sleep profiler
Sleep quality
measure of sleep quality using Sleep profiler
Surgical performance
assessing surgical performance using a high-end virtual reality simulator for intraocular surgery training

Full Information

First Posted
June 22, 2021
Last Updated
June 3, 2022
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
University Clermont Auvergne (UCA), Clermont-Ferrand, France, LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France
search

1. Study Identification

Unique Protocol Identification Number
NCT04959838
Brief Title
JOB STRESS in OPHthalmology Physicians and Residents
Acronym
JOBSTRESS-OPH
Official Title
Monitoring of JOB STRESS Related to Night Shifts in OPHthalmology Physicians and Residents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
University Clermont Auvergne (UCA), Clermont-Ferrand, France, LaPSCO laboratory, UMR CNRS 6024, Clermont-Ferrand, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Heart Rate Variability
Keywords
ophthalmologists, on-call duty, stress, surgical simulator, heart rate variability, sleep, questionnaires, actimetry

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ophthalmology physicians and residents
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Impact of prolonged work
Intervention Description
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 Measure Information:
Title
Heart rate variability
Description
HRV will be explored in time and frequency domains Abrupt changes in HRV signals will be explored.
Time Frame
During 34 hours in the five different conditions
Secondary Outcome Measure Information:
Title
change in stress levels
Description
measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 8am, beginning of the 34 hours follow-up, in the five different conditions
Title
change in stress levels
Description
measure of stress using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 6pm, end of the 34 hours follow-up, in the five different conditions
Title
change in fatigue levels
Description
measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 8am, beginning of the 34 hours follow-up, in the five different conditions
Title
change in fatigue levels
Description
measure of fatigue using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 6pm, end of the 34 hours follow-up, in the five different conditions
Title
change in burnout levels
Description
measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 8am, beginning of the 34 hours follow-up, in the five different conditions
Title
change in burnout levels
Description
measure of burnout using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 6pm, end of the 34 hours follow-up, in the five different conditions
Title
change in depression levels
Description
measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 8am, beginning of the 34 hours follow-up, in the five different conditions
Title
change in depression levels
Description
measure of depression using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 6pm, end of the 34 hours follow-up, in the five different conditions
Title
change in anxiety levels
Description
measure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 8am, beginning of the 34 hours follow-up, in the five different conditions
Title
change in anxiety levels
Description
measure of anxiety using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 6pm, end of the 34 hours follow-up, in the five different conditions
Title
change in "Job demand control support" levels
Description
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.
Time Frame
at 8am, beginning of the 34 hours follow-up, in the five different conditions
Title
change in "Job demand control support" levels
Description
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.
Time Frame
at 6pm, end of the 34 hours follow-up, in the five different conditions
Title
change in "Effort reward imbalance" levels
Description
measure of effort reward imbalance using visual analogue scale of 100 mm, from 0 to 100. Higher scores of mean a better outcome level.
Time Frame
at 8am, beginning of the 34 hours follow-up, in the five different conditions
Title
change in "Effort reward imbalance" levels
Description
measure of effort reward imbalance using visual analogue scale of 100 mm, from 0 to 100. Higher scores of mean a better outcome level.
Time Frame
at 6pm, end of the 34 hours follow-up, in the five different conditions
Title
change in work addiction levels
Description
measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 8am, beginning of the 34 hours follow-up, in the five different conditions
Title
change in work addiction levels
Description
measure of work addiction using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 6pm, end of the 34 hours follow-up, in the five different conditions
Title
change in sleep quality
Description
measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 8am, beginning of the 34 hours follow-up, in the five different conditions
Title
change in sleep quality
Description
measure of sleep quality using visual analogue scale of 100 mm, from 0 to 100. Higher scores mean a worse outcome level.
Time Frame
at 6pm, end of the 34 hours follow-up, in the five different conditions
Title
Saliva biomarkers cortisol
Description
measure on Cortisol
Time Frame
baseline of the 34 hours procedure, in the five different conditions
Title
Saliva biomarkers cortisol
Description
measure on Cortisol
Time Frame
24hours after the beginning of the procedure, in the five different conditions
Title
Saliva biomarkers dheas
Description
measure on dheas
Time Frame
baseline of the 34 hours procedure, in the five different conditions
Title
Saliva biomarkers dheas
Description
measure on dheas
Time Frame
24 hours after the beginning of the procedure, in the five different conditions
Title
Saliva biomarkers lgAs
Description
measure on lgAs
Time Frame
baseline of the 34 hours procedure, in the five different conditions
Title
Saliva biomarkers lgAs
Description
measure on lgAs
Time Frame
24 hours after the beginning of the procedure, in the five different conditions
Title
Saliva biomarkers Leptine
Description
measure on Leptine
Time Frame
baseline of the 34 hours procedure, in the five different conditions
Title
Saliva biomarkers Leptine
Description
measure on Leptine
Time Frame
24 hours after the beginning of the procedure, in the five different conditions
Title
Saliva biomarkers Ghrelin
Description
measure on Ghrelin
Time Frame
baseline of the 34 hours procedure, in the five different conditions
Title
Saliva biomarkers Ghrelin
Description
measure on Ghrelin
Time Frame
24 hours after the beginning of the procedure, in the five different conditions
Title
Declared level of physical activity
Description
Physical activity is assessed with one question
Time Frame
once at 8am, at the beginning of the procedure
Title
Level of physical activity
Description
Physical activity is assessed with a 3-Axis accelerometer
Time Frame
during 34 hours, in the five different conditions
Title
Level of sedentary
Description
Sedentary is assessed regarding the time spent sitting assessed with one question
Time Frame
once at 8am, at the beginning of the procedure
Title
Food intake
Description
assessing food intake with ingesta
Time Frame
34 hours recording, in the five different conditions
Title
Sick leave
Description
assessing the number of absence days the previous 6 months using a questionnaire
Time Frame
once at 8am, at the beginning of the procedure
Title
Height
Description
measure of height in cm using a questionnaire
Time Frame
once at 8am, at the beginning of the procedure
Title
Weight
Description
measure of weight in kilograms using a questionnaire
Time Frame
once at 8am, at the beginning of the procedure
Title
Age
Description
measure of age in years using a questionnaire
Time Frame
once at 8am, at the beginning of the procedure
Title
Gender
Description
measure of gender using a questionnaire
Time Frame
once at 8am, at the beginning of the procedure
Title
Qualification
Description
measure of qualification using a questionnaire
Time Frame
once at 8am, at the beginning of the procedure
Title
Personal status
Description
measure of personal status using a questionnaire
Time Frame
once at 8amat the beginning of the procedure
Title
Lifestyle
Description
Assessing factors related to lifestyle as smoking, alcohol and coffee consumption using a questionnaire
Time Frame
once at 8am, at the beginning of the procedure
Title
Skin conductance
Description
measure of the skin conductance using Wrist band electrodes
Time Frame
during 34 hours , in the five different conditions
Title
Sleep quality
Description
measure of sleep quality using Sleep profiler
Time Frame
measure for about 7 hours the night of the control day (no work)
Title
Sleep quality
Description
measure of sleep quality using Sleep profiler
Time Frame
measure for about 7 hours during the night of the typical working day
Title
Surgical performance
Description
assessing surgical performance using a high-end virtual reality simulator for intraocular surgery training
Time Frame
Once at 6pm, at the end of the 34 hours follow-up , in the five different conditions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric DUTHEIL
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Frédéric DUTHEIL

12. IPD Sharing Statement

Learn more about this trial

JOB STRESS in OPHthalmology Physicians and Residents

We'll reach out to this number within 24 hrs