Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04849546 |
| Other study ID # |
SAMAF - 29BRC21.0125 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
September 1, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
University Hospital, Brest |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Objectives: This study compare the mental health impact and psychosocial perception of
healthcare workers and non healthcare workers in hospital after the first peak of COVID-19
outbreak in France.
Methods: The validated SATIN questionnaire with specific scoring was used to collect data on
health and psychosocial factors. A self-administered online questionnaire was send to all
workers of the hospital in June 2020. A multinomial regression model was created to assess
differences and risk factors in outcomes between healthcare workers and non healthcare
workers. Variables were adjusted for age, sexe, frontline workplaces and experience at
hospital.
Description:
The survey was conducted between 01 th of July and 31th of August 2020 and involved all
workers employed in a teaching hospital in France. The total number of workers was 7299.
The Inclusion criteria were as follows: working in the hospital since more than one year,
adults over than 18 years, acceptance.
Questionnaire After SATIN questionnaire authors allowing, we created a specific questionnaire
with all original questions and some additional on workplaces and demographics' data. In
first question, participants must check that they met inclusion criteria and accept to be
included in this survey. An open question was available at the end for remarks.
86 questions in 6 parts: 1. Personnel and Professional Identification (10 questions) 2.
Health reports (16 questions) 3. Work strain and capacities (8 questions) 4. Working
environment (39 questions) 5. Work assessment (4 questions) 6. Supplementary questions for
occupational physician (9 questions) Each question had five possible answers and each answer
is linked to a specific score. Mean of scores were calculated in each part of the
questionnaire: health reports (physical health, psychic health, physical symptoms,
psycho-somatic symptoms, and stress), work strain and ability, working environment (physical
environment, activity, framework of activities and organizational context), self-assessed
work conditions in their entirety. The scores of each part were interpreted as follows: <2.5
poor health or negative perception, 2.5-3.5 mild health or perception, > 3.5 good health or
positive perception. Global health and general workplace environment self-evaluation were
scored in a second time with respectively health reports and working environment scores.
Demographic data were self-reported by the participants including occupation, sexe
(male/female), age (<34, 35-44, 45-54, >55 years), time at workplace (<5, 6-15, 16-26,>26
years), shift work or night work (never, rarely, regularly, often/very often).
Statistical analyses. Data analysis was performed using R software (R Foundation for
Statistical Computing, Vienna, Austria). The results for continuous variables were shown as
medians with Interquartile range (IQRs). The ranked data, which were ranked from each part of
the questionnaire, are presented as numbers and percentages. Participants were divided into
three groups according to the previously reported questionnaire cut-off (<2.5; 2.5-3.5; >
3.5). Doctor, nurse, medical student, nurse assistant, midwife, paramedics, physiotherapist
and radiographer were included in the subgroup "health care worker", other participants were
included in the subgroup "non healthcare worker". We also made an analysis by subgroup of
workers if they regularly or not worked in a COVID 19 dedicated sector. A multinomial
logistic regression analysis was performed and the associations between risk factors and
outcomes are presented as Odds Ratio (ORs) and 95% Confidence Intervals (Cis), after
adjustment for cofounders including, gender, age, years at workplace. The significant level
was set at p= 0.05.
