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Completed

NCT Number: NCT04757285

Copeptin and Psychological Stress of Medic 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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].
  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2021
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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