Сhanges in the Cardiovascular System in Healthcare Workers During Work ShiftNCT05491148
Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns
An observational study of Сhanges in the Cardiovascular System in Healthcare Workers During Work Shift, run by Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" at 1 site in Russia.
Trial summary
The purpose of this work is to assess the functional state of the body of medical workers in the neonatal resuscitation and intensive care unit in the conditions of work. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Сhanges in the Cardiovascular System in Healthcare Workers During Work Shift
- What is being tested?
- work conditions
- How many people
- 17 participants
- Where
- 1 siteRussia
- Study dates
- 29 Aug 2022to 10 Oct 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy medical workers in neonatal intensive care unit
Who may be able to join
- the volunteer has practical experience in the neonatal intensive care unit
- digestive tract, kidney, cardiorespiratory system, mervous system or musculoskeletal system pathology
Who cannot join
- acute and chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys
- body temperature above 37 ° C, heart rate over 90 beats / min, systolic and diastolic blood pressure above 140 mm Hg. Art. and 90 mm Hg. Art.
- organic brain lesions, increased convulsive activity in history
- receiving more than 10 units. alcohol per week or history of alcoholism, drug addiction, drug abuse
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health
Moscow, 105275
About this study
The purpose of this work is to assess the functional state of the body of medical workers in the neonatal resuscitation and intensive care unit in the conditions of work.
- Being tested
- work conditions
- Keywords
- functional state of the body, medical personnel, heart rate variability, cognitive functions, cardiovascular system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
work conditionsOther
an increased degree of responsibility for the life of newborns, high psycho-emotional stress, intellectual stress, an irrational work and rest regime, in connection with the COVID-19 pandemic, also using personal protective equipment against biological factors
| Study group | Role | What they receive |
|---|---|---|
| medical workers | medical workers of the resuscitation and intensive care unit of newborns Receives: Other: work conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
bpm, "Armed": "YE-630A" (ТМ "ARMED", Russia)
Measured: 8 hours
Blood pressure
mm Hg, "Armed": "YE-630A" (ТМ "ARMED", Russia)
Measured: 8 hours
Anthropometry (Height)
Height (cm), weight (kg), Seca 703 ("Seca GMBH\&Co", Germany)
Measured: 1 hour
Anthropometry (Weight)
Weight (kg), Seca 703 ("Seca GMBH\&Co", Germany)
Measured: 1 hour
Body temperature
Celsius, Thermoval Standard ("PAUL HARTMANN", Germany)
Measured: 1 hour
Electrocardiography
Electrocardiogram analysis, Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
Measured: 1 hour
Cognitive functions test 1
Bourdon correction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
Measured: 1 hour
Cognitive functions test 2
Simple visual-motor reaction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
Measured: 1 hour
Cognitive functions test 3
Growing account test. Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
Measured: 1 hour
Secondary outcomes (1)
Survey
Subjective survey on functional state of the body (7 scales)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start29 Aug 2022
- Primary completion5 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Сhanges in the Cardiovascular System in Healthcare Workers During Work ShiftStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrey Mikhailovich Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
- Investigators
- Inga Malakhova, Principal investigator, Junior scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491148
- Sponsor's protocol ID
- PPE-06
- Status last verified
- May 2023
- First submitted
- 4 Aug 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns
- ClinicalTrials.gov ID
- NCT05491148
- Acronym / sponsor ID
- PPE-06
- Keywords
- functional state of the body, medical personnel, heart rate variability, cognitive functions, cardiovascular system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"University, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 8 Aug 2022 (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.
The purpose of this work is to assess the functional state of the body of medical workers in the neonatal resuscitation and intensive care unit in the conditions of work.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical workers | – | Other: work conditionsmedical workers of the resuscitation and intensive care unit of newborns |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy medical workers in neonatal intensive care unit
Key inclusion criteria (2 listed)
- the volunteer has practical experience in the neonatal intensive care unit
- digestive tract, kidney, cardiorespiratory system, mervous system or musculoskeletal system pathology
Key exclusion criteria (4 listed)
- acute and chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys
- body temperature above 37 ° C, heart rate over 90 beats / min, systolic and diastolic blood pressure above 140 mm Hg. Art. and 90 mm Hg. Art.
- organic brain lesions, increased convulsive activity in history
- receiving more than 10 units. alcohol per week or history of alcoholism, drug addiction, drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| work conditionsan increased degree of responsibility for the life of newborns, high psycho-emotional stress, intellectual stress, an irrational work and rest regime, in connection with the COVID-19 pandemic, also using personal protective equipment against biological factors | Other | medical workers |
Primary outcome
Heart rate
Time frame: 8 hours
bpm, "Armed": "YE-630A" (ТМ "ARMED", Russia)
Blood pressure
Time frame: 8 hours
mm Hg, "Armed": "YE-630A" (ТМ "ARMED", Russia)
Anthropometry (Height)
Time frame: 1 hour
Height (cm), weight (kg), Seca 703 ("Seca GMBH\&Co", Germany)
Anthropometry (Weight)
Time frame: 1 hour
Weight (kg), Seca 703 ("Seca GMBH\&Co", Germany)
Body temperature
Time frame: 1 hour
Celsius, Thermoval Standard ("PAUL HARTMANN", Germany)
Electrocardiography
Time frame: 1 hour
Electrocardiogram analysis, Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
Cognitive functions test 1
Time frame: 1 hour
Bourdon correction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
Cognitive functions test 2
Time frame: 1 hour
Simple visual-motor reaction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
Cognitive functions test 3
Time frame: 1 hour
Growing account test. Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
1 secondary outcome
Survey
Time frame: 1 hour
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 16 May 2023.
- Individual participant dataSharing planned: No
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.
Inga Malakhova principal investigator
Junior scientist
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 Сhanges in the Cardiovascular System in Healthcare Workers During Work Shift, run by Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" at 1 site in Russia.
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 2 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 16 May 2023. 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 Russia. 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?
Heart rate (time frame: 8 hours). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2023.