Copeptin and Psychological Stress of Medic During COVID-19 Pandemic

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT04757285
Collaborator
(none)
90
1
5.7
15.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    90 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Serum Copeptin and Psychological Stress Level Among Healthcare Providers During COVID-19 Pandemic
    Actual Study Start Date :
    May 10, 2020
    Actual Primary Completion Date :
    Oct 30, 2020
    Actual Study Completion Date :
    Oct 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. evaluation of psychological stress [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].

    2. determine stress hormones in serum cortisol and copeptin [four weeks for each participant..]

      Second to determine stress hormones copeptin and cortisol (possible stress biomarkers) concurrently with questionnaire.

    Secondary Outcome Measures

    1. correlation of psychological stress with stress hormone copeptin [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    24 Years to 37 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alexandria University Faculty of Medicine Alexandria Egypt 21311

    Sponsors and Collaborators

    • Alexandria University

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    hala mourad demerdash, Consultant Clinical Pathology, Alexandria University
    ClinicalTrials.gov Identifier:
    NCT04757285
    Other Study ID Numbers:
    • 0304842
    First Posted:
    Feb 17, 2021
    Last Update Posted:
    Feb 17, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by hala mourad demerdash, Consultant Clinical Pathology, Alexandria University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 17, 2021