Copeptin and Psychological Stress of Medic During COVID-19 Pandemic (COVID-19)

February 15, 2021 updated by: hala mourad demerdash, Alexandria University

Evaluation of Serum Copeptin and Psychological Stress Level Among Healthcare Providers During COVID-19 Pandemic

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.

Study Overview

Status

Completed

Conditions

Detailed Description

A total of 70 healthcare personnel volunteers participated; 35 physicians and 35 nurses. All healthcare providers' volunteers are in good physical health, Exclusion criteria included hypertension, diabetes mellitus, obesity BMI ≥30, subjects with serum sodium ≤135 or ≥ 145 mmol /L at baseline or females receiving contraceptive pills.

During the research participants will answer a questionnaire as well as three blood samples are taken.

  • In the first meeting, evaluation of participant general condition; determining BMI, blood pressure. Then a small amount of blood, equal to about two millimeters, will be taken from participant arm with a syringe. This blood will be tested for serum copeptin, cortisol (fasting morning sample). The investigator will ask participant few questions to evaluate the level of stress (as anxiety, insomnia, fear of infection through questionnaire)
  • The second meeting, one week after work in ICU, another blood sample will be taken from participant and determine level of psychological stress.
  • The third meeting, two weeks after leave from ICU participant blood sample will be taken from participant to determine stress hormones and determine level of psychological stress.

Duration

The research takes place over six months in total.

Study Type

Observational

Enrollment (Actual)

90

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

  • Egypt
      • Alexandria, Egypt, 21311
        • Alexandria University Faculty of Medicine

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

24 years to 37 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthcare providers worked in ICU: 35 physicians (28 males and 7 females) and 35 nurses (10 males and 25 females). Age ranged from 24 to 37 years All volunteers were in good physical health Exclusion criteria included hypertension, diabetes mellitus, obesity BMI ≥30, subjects with serum sodium ≤135 or ≥ 145 mmol /L at baseline or females receiving contraceptive pills.

Group Information healthcare providers designated to take duty shifts at ICU in Alexandria quarantine hospitals for two weeks during COVID-19 pandemic. And a control group of healthcare providers not assigned to work in quarantine hospitals.

First assembly one day before enrolling to work in ICU. Second assembly at the end of first week of work, third assembly two weeks after departure from work in ICU

Description

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

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
control group
25 healthcare personnel volunteers not working in quarantine hospitals of matched age
healthcare providers worked in Intensive Care Units

35 physicians (28 males and 7 females) and 35 nurses (10 males and 25 females). All volunteers were in good physical health Exclusion criteria included hypertension, diabetes mellitus, obesity BMI ≥30, subjects with serum sodium ≤135 or ≥ 145 mmol /L at baseline or females receiving contraceptive pills.

Assigned participants were clinically evaluated for as hypertension, DM, dyslipidemia, renal function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evaluation of psychological stress
Time Frame: four weeks for each participant.
- 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.
determine stress hormones in serum cortisol and copeptin
Time Frame: four weeks for each participant..
Second to determine stress hormones copeptin and cortisol (possible stress biomarkers) concurrently with questionnaire.
four weeks for each participant..

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of psychological stress with stress hormone copeptin
Time Frame: four weeks for each participant..
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..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

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

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)

May 10, 2020

Primary Completion (Actual)

October 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

February 6, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0304842

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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