- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04961372
Socio-psychological Status of Healthcare Workers During SARS-CoV2 Pandemic
March 22, 2022 updated by: Hakan Gokalp TAS, Erzincan University
The aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.
Study Overview
Detailed Description
Severe Acute Respiratory Syndrome - Corona Virus 2 (SARS-CoV2) was detected by the Chinese Center for Disease Control and Prevention on 7 January 2020 in a patient with atypical pneumonia in Wuhan, China, via a nasopharyngeal swab.
On March 11, 2020, the World Health Organization declared it a "Pandemic".
SARS-CoV2 quickly turned into a global epidemic, with a total of 134,957,021 confirmed cases and 2,918,752 deaths reported in April 2021.Since SARS-CoV2 is a highly contagious disease, the risk of infection in healthcare workers is quite high.
In one of the earliest studies in Wuhan, 29 percent of patients (40 out of 138) were reported to be healthcare workers.
A report from the American Centers for Disease Control and Prevention (CDC) stated that a total of 9,282 healthcare workers were diagnosed with COVID-19, including 27 deaths, between February 12 and April 9, 2020.
Eleven to nineteen percent of COVID-19 cases have been identified as healthcare professionals.As the investigators have seen in studies of SARS or Ebola outbreaks, the sudden onset of an immediately life-threatening epidemic can place an extraordinary amount of pressure on healthcare workers.
Increased workload, physical fatigue, inadequate personal equipment, nosocomial transmission, and having to make ethically difficult decisions can have dramatic effects on their physical and mental health.
The weight of working conditions together with the risk of illness of their social environment and families can cause mental health problems such as fear and anxiety in healthcare workers.When an effective vaccination program is in place, population uptake should be as high as possible to achieve herd immunity.
Vaccination hesitancy, defined as a delay in acceptance or rejection of vaccination despite the availability of vaccination services, is one of the barriers to this.
It is a complex special case that varies with time, place, and vaccines.
It is influenced by factors such as peace of mind, convenience, and trust.
Vaccine hesitations have been identified as one of the ten global health threats of 2019.The aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the SARS-CoV2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.
Study Type
Observational
Enrollment (Actual)
333
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
-
-
Siran
-
Gumushane, Siran, Turkey, 29700
- Siran Government Hospital
-
-
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All healthcare workers aged between 18-65 who works at Siran Government Hospital (111 volunteers) and 222 healthy volunteers who are non-healthcare workers.
Description
Inclusion Criteria:
- All healthcare workers aged between 18-65 who works at Siran Government Hospital
Exclusion Criteria:
- Participants who did not agree to participate in the study
- Uncooperative participants
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
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthcare Workers
All healthcare professionals working at Gümüşhane Şiran Government Hospital
|
PHQ9 Depression Scale for evaluating depression, GAD7 Anxiety Score for evaluating anxiety, WSAS Score for evaluating Work and Social Adjustment
|
|
Non-Healthcare Workers
Twice the number of health workers included in the study, non-health worker volunteers
|
PHQ9 Depression Scale for evaluating depression, GAD7 Anxiety Score for evaluating anxiety, WSAS Score for evaluating Work and Social Adjustment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire-9 Score
Time Frame: 6 Months
|
Depression Score.1-4
Minimal depression,5-9 Mild depression,10-14 Moderate depression,15-19 Moderately severe depression,20-27 Severe depression
|
6 Months
|
|
Generalised Anxiety Disorder Assessment Score
Time Frame: 6 Months
|
Anxiety Score.
0-4: minimal anxiety,5-9: mild anxiety,10-14: moderate anxiety,15-21: severe anxiety
|
6 Months
|
|
Work and Social Adjustment Score
Time Frame: 6 Months
|
Work and Social Adjustment Score.
WSAS score above 20 appears to suggest moderately severe or worse psychopathology.
Scores between 10 and 20 are associated with significant functional impairment but less severe clinical symptomatology.
Scores below 10 appear to be associated with subclinical populations
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
- Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
- Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- Wu P, Fang Y, Guan Z, Fan B, Kong J, Yao Z, Liu X, Fuller CJ, Susser E, Lu J, Hoven CW. The psychological impact of the SARS epidemic on hospital employees in China: exposure, risk perception, and altruistic acceptance of risk. Can J Psychiatry. 2009 May;54(5):302-11. doi: 10.1177/070674370905400504.
- MacDonald NE; SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: Definition, scope and determinants. Vaccine. 2015 Aug 14;33(34):4161-4. doi: 10.1016/j.vaccine.2015.04.036. Epub 2015 Apr 17.
- CDC COVID-19 Response Team. Characteristics of Health Care Personnel with COVID-19 - United States, February 12-April 9, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):477-481. doi: 10.15585/mmwr.mm6915e6.
- WHO. WHO Coronavirus (COVID-19) Dashboard [Web Page]. 2021 [updated 11.04.2021. WHO Coronavirus (COVID-19) Dashboard]. Available from: https://covid19.who.int/.
- Liu X, Kakade M, Fuller CJ, Fan B, Fang Y, Kong J, Guan Z, Wu P. Depression after exposure to stressful events: lessons learned from the severe acute respiratory syndrome epidemic. Compr Psychiatry. 2012 Jan;53(1):15-23. doi: 10.1016/j.comppsych.2011.02.003. Epub 2011 Apr 12.
- Lung FW, Lu YC, Chang YY, Shu BC. Mental Symptoms in Different Health Professionals During the SARS Attack: A Follow-up Study. Psychiatr Q. 2009 Jun;80(2):107-16. doi: 10.1007/s11126-009-9095-5. Epub 2009 Feb 27.
- Fontanet A, Cauchemez S. COVID-19 herd immunity: where are we? Nat Rev Immunol. 2020 Oct;20(10):583-584. doi: 10.1038/s41577-020-00451-5.
- Ashby B, Best A. Herd immunity. Curr Biol. 2021 Feb 22;31(4):R174-R177. doi: 10.1016/j.cub.2021.01.006. Epub 2021 Jan 12.
- Swaminathan S. The WHO's chief scientist on a year of loss and learning. Nature. 2020 Dec;588(7839):583-585. doi: 10.1038/d41586-020-03556-y. No abstract available.
- Thangaraju P, Venkatesan SJCMJ. WHO Ten threats to global health in 2019: Antimicrobial resistance. 2019;44(3):1150-1.
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)
March 1, 2021
Primary Completion (Actual)
September 1, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
July 1, 2021
First Submitted That Met QC Criteria
July 8, 2021
First Posted (Actual)
July 14, 2021
Study Record Updates
Last Update Posted (Actual)
March 23, 2022
Last Update Submitted That Met QC Criteria
March 22, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ErzincanUniversity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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