Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02401607 |
| Other study ID # |
CHU-0228 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2015 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
February 2021 |
| Source |
University Hospital, Clermont-Ferrand |
| Contact |
Lise Laclautre |
| Phone |
04 73 75 11 95 |
| Email |
promo_interne_drci[@]chu-clermontferrand.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Emergency health care workers are exposed to job strain - defined by Karasek as a combination
of high job demands and low job control. Emergency health care work is a complex interaction
between stress due to life-threatening emergencies, overcrowding of the Emergency Department,
the lack of sleep, bad food repartition during shifts, and accumulated fatigue. However, the
Karasek questionnaire has never been assessed for Emergency Health Care workers. Furthermore,
the variation of results during the career has never been assessed.
The same measures will be repeated every 5 year to assess long term changes in subjective and
objective measures of stress.
The study's main objective is the creation of an Emergency Health Care worker's cohort to
assess the evolution of the Karasek questionnaire during the follow-up.
Secondary objectives are
- the evaluation of the food intake before, during and after a nightshift.
- the evaluation of other questionnaires
Description:
Chronic stress at work is a public health problem increasing morbidity and mortality.
Emergency physicians is particularly an at risk population. Indeed, their work is a complex
interaction between stress due to life-threatening emergencies, the lack of sleep and
accumulated fatigue.
A way of measuring stress at work is the use of self-reported psychological questionnaire.
Among them, the Job control demand model from Karasek is widely used to evaluate psychosocial
factors at work. The Karasek job strain model has been assessed in 25 000 workers in the
Sumer study and allowed to classify the main types of occupations. However, no data regarding
emergency physicians scores at the Karasek questionnaire were available, even though burnout
exposure is a well-known problematic among health care workers. This absence is particularly
unfortunate as emergency physicians often needs to deals with life threatening emergency in a
short amount of time, following regularly long and craving shifts. A preliminary study with a
low sample size reported in concrete terms the atypical "out of limit" situations of
emergency physicians, with a decision latitude among the lowest and the highest psychological
demand ever reported. Moreover, variation of stress at work has been linked with professional
experiences. Karasek questionnaire is supposed to assess a long-term stable perception of
work, despite the absence of study comparing Karasek scores within different conditions in
the same participant. It is also important to explore protective factors that might help
alleviate perceived stress and that are quite easy to integrate into medical organizations or
in daily lifestyle.
Finally, several biomarkers of stress have been proposed. Among them, our team previously
highlighted the potential of DHEAS to assess stress, due to its stability (steroid) and its
long half-life of 16 hours. To our knowledge, the relationships between biomarkers of stress
and the Karasek job strain model have never been investigated. Comparisons between emergency
health care workers are also lacking.
Therefore, the general aim of this study is to enhance psychological well-being in emergency
physicians. The primary objective is to verify our preliminary findings at Karasek scores on
a large sample size of emergency physicians. The secondary objectives are to evaluate whether
there is a change in perception of work both at short-term (on leave and after a 24-hour
shift) and long-term (with professional experience). We will further explore its
relationships with some biomarkers of stress and protective factors. Moreover, we aim to
compare emergency health care workers specificity.
Questionnaires and saliva collection will be performed twice: at the beginning of a day work
and at the end of a night work. Both measures will be recorded at the same time within each
participant, between 6.30 am and 8.30 am depending of the health care workers. The time
required by participant is evaluated to about 15min each time.
The same measures will be repeated every 5 year to assess long term changes in subjective and
objective measures of stress.
The population description will be achieved with descriptive statistics. Continuous variables
will be presented as mean and standard deviation, under the normality of distribution
condition (Shapiro-Wilk needed).
The primary analysis will be mainly descriptive and will express (as a quantitative and
categorical variables) the perception scores of emergency physicians work according to the
Karasek questionnaire, for each dimensions composing the score (decision latitude,
psychological demands and social support).
The evolution of the Karasek questionnaire score, obtained for each dimension, will be tested
with a paired two-sample emergency physician's test (or nonparametric Wilcoxon test if
necessary). Linear regression models or aleatory effects models (as described by Klar and
Darlington, 2004, in Statistics in Medicine) will eventualy complete these analyzes. This
will permit, with multivariate analyzes and the introduction of covariates, to seek for
possible explanatory factors of the Karasek score and its evolution. The same process will be
used for quantitative parameters that will be collected.
All statistical analyses will be performed as bilateral tests with a p <0.05 considered as
significant. Statistical analyzes will be performed using STATA 16 software (Stata
Corporation, College Station).
