Psychological Stress Clinical Trial
— COVID-19Official title:
Evaluation of Serum Copeptin and Psychological Stress Level Among Healthcare Providers During COVID-19 Pandemic
NCT number | NCT04757285 |
Other study ID # | 0304842 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 10, 2020 |
Est. completion date | October 30, 2020 |
Verified date | February 2021 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Psychological stress (PSS) is one of the most common problems among healthcare providers during COVID-19 pandemic. PSS influences the homeostatic equilibrium of the body, involving activation of the sympathetic nervous system and hypothalamus pituitary adrenal (HPA) axis. Copeptin; C-terminal portion of Vasopressin (AVP) precursor is stable. Nevertheless, Evidence about influence of PSS on copeptin levels is lacking. The reason we are doing this research is to determine the level of psychological stress among healthcare providers exposed to at the time of work in intensive care unit (ICU) during COVID-19 pandemic; They will be appraised every assembly for psychological stress level; before start of duty shifts (first time), one week after start (second time) and two weeks after departure from shift duties in ICU (third time) for assessment of psychological stress level and stress hormones.
Status | Completed |
Enrollment | 90 |
Est. completion date | October 30, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 24 Years to 37 Years |
Eligibility | Inclusion Criteria: physicians and nurses under age of 37 years in good health Exclusion Criteria: - body mass index above 30 - hypertension - Diabetes mellitus - females receiving contraceptive pills |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria University Faculty of Medicine | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Christ-Crain M, Fenske W. Copeptin in the diagnosis of vasopressin-dependent disorders of fluid homeostasis. Nat Rev Endocrinol. 2016 Mar;12(3):168-76. doi: 10.1038/nrendo.2015.224. Epub 2016 Jan 22. Review. — View Citation
McEwen BS. Protective and damaging effects of stress mediators: central role of the brain. Dialogues Clin Neurosci. 2006;8(4):367-81. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | evaluation of psychological stress | - Primarily outcome determination of psychological stress among doctors and nurses working in ICU through a questionnaire before duty shifts [first time] and re-evaluate it after one week of work in ICU [second time], and lastly two weeks after departure from shift duties [third time]. | four weeks for each participant. | |
Primary | determine stress hormones in serum cortisol and copeptin | Second to determine stress hormones copeptin and cortisol (possible stress biomarkers) concurrently with questionnaire. | four weeks for each participant.. | |
Secondary | correlation of psychological stress with stress hormone copeptin | correlate the level of psychological stress calculated from provided questionnaire in the three assemblies with stress biomarkers copeptin and cortisol in the three measurements. | four weeks for each participant.. |
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