Psychological StressCOVID-19NCT04757285
Copeptin and Psychological Stress of Medic During COVID-19 Pandemic
An observational study of Psychological Stress and Hemostatic Disorder, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress, Hemostatic Disorder
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2020to 30 Oct 2020
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 37 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- physicians and nurses under age of 37 years in good health
Who cannot join
- body mass index above 30
- hypertension
- Diabetes mellitus
- females receiving contraceptive pills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Stress, Hemostatic Disorder
- Keywords
- psychological stress, copeptin, hormones
- Medical subject headings
- Stress, Psychological, Hemostatic Disorders, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: four weeks for each participant.
determine stress hormones in serum cortisol and copeptin
Second to determine stress hormones copeptin and cortisol (possible stress biomarkers) concurrently with questionnaire.
Measured: four weeks for each participant..
Secondary outcomes (1)
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.
Measured: four weeks for each participant..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start10 May 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hala mourad demerdash, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757285
- Sponsor's protocol ID
- 0304842
- Acronym
- COVID-19
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McEwen BS. Protective and damaging effects of stress mediators: central role of the brain. Dialogues Clin Neurosci. 2006;8(4):367-81. doi: 10.31887/DCNS.2006.8.4/bmcewen.
PubMed 17290796Christ-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.
PubMed 26794439
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Copeptin and Psychological Stress Level Among Healthcare Providers During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04757285
- Acronym / sponsor ID
- COVID-19 / 0304842
- Conditions
- Psychological Stress, Hemostatic Disorder
- Keywords
- psychological stress, copeptin, hormones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 May 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 24 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- physicians and nurses under age of 37 years in good health
Key exclusion criteria (4 listed)
- body mass index above 30
- hypertension
- Diabetes mellitus
- females receiving contraceptive pills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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].
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.
1 secondary outcome
correlation of psychological stress with stress hormone copeptin
Time frame: four weeks for each participant..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Results publication: PubMed 17290796McEwen BS. Protective and damaging effects of stress mediators: central role of the brain. Dialogues Clin Neurosci. 2006;8(4):367-81. doi: 10.31887/DCNS.2006.8.4/bmcewen.
- Results publication: PubMed 26794439Christ-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Stress and Hemostatic Disorder, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of psychological stress (time frame: four weeks for each participant.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04757285, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.