- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04604769
Perceived Stress Among ICU Medical Staff During COVID-19 Crisis (ICUcovid)
October 26, 2020 updated by: Audrey Vanhaudenhuyse, University of Liege
Perceived Stress and Needs Among Medical Staff in ICU During COVID-19 Crisis
The objective of this study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.
Study Overview
Status
Completed
Conditions
Detailed Description
Well-being of caregivers and stress management in intensive care units are essential keys to an adequate quality of care, especially during the anxious context of coronavirus pandemic.
Taking care of numerous patients, the increasing work and mental charges, facing death, the need of material and changes in work organization are all elements that can influence stress among medical workers.
Considering real causes of stress and what are the needs of the medical team is fundamental for developing concrete actions to ease the workloads.
A few studies were conducted in China on psychological distress of medical staff during COVID-19.
According to these few studies about psychological distress in ICU, investigators think that stress scores during COVID-19 could be increased among nurses during pandemic.
The second hypothesis is that causes of stress would be not so different from normal care but could be amplified by the actual situation.
One point to take into consideration is that most of the studies were conducted in China and medical policy and hospital organization are different in Belgium.
The objective of the study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Province De Liège
-
Liège, Province De Liège, Belgium, 4000
- University of Liege
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Nurses and doctors working in intensive care units before and during the COVID pandemic.
Description
Inclusion Criteria:
- Adults > 18 years old
- working in ICU for at least November 2019
- working in ICU regularly since March 2020
- Medical and paramedical professionals
- Working in direct contact with COVID patients
Exclusion Criteria:
- Medical professionals from others departments
- Internship students
- External volunteers for COVID
- Non front-line nurses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Daily routine, control group
ICU medical staff were asked about their stress and causes of stress during their daily professional life.
|
|
During Covid-19
ICU medical staff were asked about their stress and causes of stress in their daily professional life during COVID-19 crisis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stress at work
Time Frame: change from baseline at one year
|
Job Content Questionnaire (Karasek, 1979)
|
change from baseline at one year
|
|
stress in a medical unit
Time Frame: change from baseline at one year
|
Nursing Stress Questionnaire (Gray-Toft, 1981)
|
change from baseline at one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hobby activities
Time Frame: change from baseline at one year
|
We will ask if they are used to do activities like hypnosis, yoga, mediation, sport, etc.
This factor could help us to know if these activities can help and if we have to promote them in the hospital.
|
change from baseline at one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne-Sophie Nyssen, Université de Liège
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2019
Primary Completion (Actual)
September 1, 2020
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
April 27, 2020
First Submitted That Met QC Criteria
October 26, 2020
First Posted (Actual)
October 27, 2020
Study Record Updates
Last Update Posted (Actual)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 26, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Stress, Psychological
- Occupational Diseases
- COVID-19
- Coronavirus Infections
- Occupational Stress
Other Study ID Numbers
- stressICUcovid
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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