CoronavirusICUcovidNCT04604769
Perceived Stress Among ICU Medical Staff During COVID-19 Crisis
An observational study of Coronavirus and Nurse's Role, run by University of Liege at 1 site in Belgium.
Trial summary
The objective of this study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus, Nurse's Role, Professional Stress
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jun 2019to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nurses and doctors working in intensive care units before and during the COVID pandemic.
Who may be able to join
- 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
Who cannot join
- Medical professionals from others departments
- Internship students
- External volunteers for COVID
- Non front-line nurses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronavirus, Nurse's Role, Professional Stress
- Keywords
- coronavirus, covid-19, pandemia, professional stress, burnout, nursing, intensive care units (ICU), infection, work organization
- Medical subject headings
- Coronavirus Infections, Occupational Stress, COVID-19, Burnout, Psychological, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
stress at work
Job Content Questionnaire (Karasek, 1979)
Measured: change from baseline at one year
stress in a medical unit
Nursing Stress Questionnaire (Gray-Toft, 1981)
Measured: change from baseline at one year
Secondary outcomes (1)
hobby activities
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.
Measured: change from baseline at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start26 Jun 2019
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrey Vanhaudenhuyse, University of Liege
- Investigators
- Anne-Sophie Nyssen, Principal investigator, Université de Liège
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604769
- Sponsor's protocol ID
- stressICUcovid
- Acronym
- ICUcovid
- Status last verified
- Oct 2020
- First submitted
- 27 Apr 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Stress and Needs Among Medical Staff in ICU During COVID-19 Crisis
- ClinicalTrials.gov ID
- NCT04604769
- Acronym / sponsor ID
- ICUcovid / stressICUcovid
- Conditions
- Coronavirus, Nurse's Role, Professional Stress
- Keywords
- coronavirus, covid-19, pandemia, professional stress, burnout, nursing, intensive care units (ICU), infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to compare psychological distress and needs of nurses in ICU before and during coronavirus pandemic.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nurses and doctors working in intensive care units before and during the COVID pandemic.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Medical professionals from others departments
- Internship students
- External volunteers for COVID
- Non front-line nurses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stress at work
Time frame: change from baseline at one year
Job Content Questionnaire (Karasek, 1979)
stress in a medical unit
Time frame: change from baseline at one year
Nursing Stress Questionnaire (Gray-Toft, 1981)
1 secondary outcome
hobby activities
Time frame: change from baseline at one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sophie Nyssen principal investigator
Université de Liège
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and Nurse's Role, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress at work (time frame: change from baseline at one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.