SARS-CoV-2NCT04779944
Impact of SARS-CoV-2 Pandemic on Psychological State of Health Care Workers
An observational study of SARS-CoV-2, run by Assiut University at 1 site in Egypt.
Trial summary
In COVID-19 pandemic, many health-care workers (HCWs) have worked in high-pressure environments. They have been exposed to and faced moral dilemmas in addition to infection exposure risk are increasing the risk of mental health disorders. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- other
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Apr 2020to 15 Aug 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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All that work in the hospitals either doctors, nurses, dentist, pharmacysit
Who may be able to join
- All health workers team
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
In COVID-19 pandemic, many health-care workers (HCWs) have worked in high-pressure environments. They have been exposed to and faced moral dilemmas in addition to infection exposure risk are increasing the risk of mental health disorders.
Read the detailed description
Throughout the SARS-CoV-2 pandemic, many HCWs have worked in high-pressure environments. Moreover, they may have been exposed to trauma and/or faced moral dilemmas relating to challenges in the delivery of high-quality care, possibly due to a lack of experience or equipment, or as a result of low staffing levels. These unfavorable circumstances and exposure risk to infection are likely to increase the risk of mental health disorders such as post-traumatic stress disorder (PTSD) or depression, other anxiety disorders, substance misuse and suicide In the present study, This study aimed to assess the psychological state of HCWs who were facing challenges of SARS-CoV-2pandemic comparing them to non medical staff group based on use of the Hamilton Anxiety and Depression Rating Scale.
- Conditions
- SARS-CoV-2
- Being tested
- other
- Keywords
- SARS-CoV-2, Anxiety, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
otherOther
Also called questionnaire
questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire to assess the psychological impacts of SARS-CoV-2 on health care workers
Impact of SARS-CoV-2 on the Psychology of health care workers
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start7 Apr 2020
- Primary completion30 Jul 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba A Yassa, Assiut University
- Investigators
- Aliae Mohamed Hussein, Principal investigator, Assiut university- professorNoha Abo Elfetoh, Study chair, Assiut university- professorHoda Makhlouf, Study chair, Assiut university- professorNahed Makhlouf, Study chair, Assiut university- professorAhmed AbdelBaqy, Study chair, Assiut university- Assistant professorHeba Yassa, Study director, Assiut university- professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779944
- Sponsor's protocol ID
- AssiutU1235
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Williamson V, Stevelink SAM, Greenberg N. Occupational moral injury and mental health: systematic review and meta-analysis. Br J Psychiatry. 2018 Jun;212(6):339-346. doi: 10.1192/bjp.2018.55.
PubMed 29786495Li R, Pei S, Chen B, Song Y, Zhang T, Yang W, Shaman J. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV-2). Science. 2020 May 1;368(6490):489-493. doi: 10.1126/science.abb3221. Epub 2020 Mar 16.
PubMed 32179701Greenberg N, Docherty M, Gnanapragasam S, Wessely S. Managing mental health challenges faced by healthcare workers during covid-19 pandemic. BMJ. 2020 Mar 26;368:m1211. doi: 10.1136/bmj.m1211. No abstract available.
PubMed 32217624Brooks S, Amlot R, Rubin GJ, Greenberg N. Psychological resilience and post-traumatic growth in disaster-exposed organisations: overview of the literature. BMJ Mil Health. 2020 Feb;166(1):52-56. doi: 10.1136/jramc-2017-000876. Epub 2018 Feb 2.
PubMed 29420257
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SARS-CoV-2 Pandemic on Psychological State of Health Care Workers
- ClinicalTrials.gov ID
- NCT04779944
- Acronym / sponsor ID
- AssiutU1235
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 3 Mar 2021 (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.
In COVID-19 pandemic, many health-care workers (HCWs) have worked in high-pressure environments. They have been exposed to and faced moral dilemmas in addition to infection exposure risk are increasing the risk of mental health disorders.
Detailed description
Throughout the SARS-CoV-2 pandemic, many HCWs have worked in high-pressure environments. Moreover, they may have been exposed to trauma and/or faced moral dilemmas relating to challenges in the delivery of high-quality care, possibly due to a lack of experience or equipment, or as a result of low staffing levels. These unfavorable circumstances and exposure risk to infection are likely to increase the risk of mental health disorders such as post-traumatic stress disorder (PTSD) or depression, other anxiety disorders, substance misuse and suicide In the present study, This study aimed to assess the psychological state of HCWs who were facing challenges of SARS-CoV-2pandemic comparing them to non medical staff group based on use of the Hamilton Anxiety and Depression Rating Scale.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All that work in the hospitals either doctors, nurses, dentist, pharmacysit
Key inclusion criteria (1 listed)
- All health workers team
Key exclusion criteria (1 listed)
- no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| otherAlso: questionnairequestionnaire | Other | – |
Primary outcome
Questionnaire to assess the psychological impacts of SARS-CoV-2 on health care workers
Time frame: 4 month
Impact of SARS-CoV-2 on the Psychology of health care workers
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 3 Mar 2021.
- Background: PubMed 29786495Williamson V, Stevelink SAM, Greenberg N. Occupational moral injury and mental health: systematic review and meta-analysis. Br J Psychiatry. 2018 Jun;212(6):339-346. doi: 10.1192/bjp.2018.55.
- Results publication: PubMed 32179701Li R, Pei S, Chen B, Song Y, Zhang T, Yang W, Shaman J. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV-2). Science. 2020 May 1;368(6490):489-493. doi: 10.1126/science.abb3221. Epub 2020 Mar 16.
- Results publication: PubMed 32217624Greenberg N, Docherty M, Gnanapragasam S, Wessely S. Managing mental health challenges faced by healthcare workers during covid-19 pandemic. BMJ. 2020 Mar 26;368:m1211. doi: 10.1136/bmj.m1211. No abstract available.
- Results publication: PubMed 29420257Brooks S, Amlot R, Rubin GJ, Greenberg N. Psychological resilience and post-traumatic growth in disaster-exposed organisations: overview of the literature. BMJ Mil Health. 2020 Feb;166(1):52-56. doi: 10.1136/jramc-2017-000876. Epub 2018 Feb 2.
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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.
Aliae Mohamed Hussein principal investigator
Assiut university- professor
Noha Abo Elfetoh study chair
Assiut university- professor
Hoda Makhlouf study chair
Assiut university- professor
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 SARS-CoV-2, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 3 Mar 2021. 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 Egypt. 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?
Questionnaire to assess the psychological impacts of SARS-CoV-2 on health care workers (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779944, which also lists 4 linked publications.
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 3 Mar 2021.