- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05491148
Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns
May 13, 2023 updated by: Andrey Mikhailovich Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
17
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
-
-
-
Moscow, Russian Federation, 105275
- Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Healthy medical workers in neonatal intensive care unit
Description
Inclusion Criteria:
- the volunteer has practical experience in the neonatal intensive care unit
- digestive tract, kidney, cardiorespiratory system, mervous system or musculoskeletal system pathology
Exclusion Criteria:
- 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
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 |
Intervention / Treatment |
---|---|
medical workers
medical workers of the resuscitation and intensive care unit of newborns
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: 8 hours
|
bpm, "Armed": "YE-630A" (ТМ "ARMED", Russia)
|
8 hours
|
Blood pressure
Time Frame: 8 hours
|
mm Hg, "Armed": "YE-630A" (ТМ "ARMED", Russia)
|
8 hours
|
Anthropometry (Height)
Time Frame: 1 hour
|
Height (cm), weight (kg), Seca 703 ("Seca GMBH&Co", Germany)
|
1 hour
|
Anthropometry (Weight)
Time Frame: 1 hour
|
Weight (kg), Seca 703 ("Seca GMBH&Co", Germany)
|
1 hour
|
Body temperature
Time Frame: 1 hour
|
Celsius, Thermoval Standard ("PAUL HARTMANN", Germany)
|
1 hour
|
Electrocardiography
Time Frame: 1 hour
|
Electrocardiogram analysis, Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
|
1 hour
|
Cognitive functions test 1
Time Frame: 1 hour
|
Bourdon correction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
|
1 hour
|
Cognitive functions test 2
Time Frame: 1 hour
|
Simple visual-motor reaction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
|
1 hour
|
Cognitive functions test 3
Time Frame: 1 hour
|
Growing account test.
Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survey
Time Frame: 1 hour
|
Subjective survey on functional state of the body (7 scales)
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Inga Malakhova, Junior scientist
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)
August 29, 2022
Primary Completion (Actual)
October 5, 2022
Study Completion (Actual)
October 10, 2022
Study Registration Dates
First Submitted
August 4, 2022
First Submitted That Met QC Criteria
August 5, 2022
First Posted (Actual)
August 8, 2022
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 13, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PPE-06
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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