Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns

Sponsor

Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05491148

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Days)

28.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Сhanges in the Cardiovascular System in Healthcare Workers During Work Shift	Other: work conditions

Study Design

Study Type:

Observational

Anticipated Enrollment :

17 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Study of the Functional State of the Body of Medical Workers in the Intensive Care Unit for Newborns

Anticipated Study Start Date :

Aug 29, 2022

Anticipated Primary Completion Date :

Sep 16, 2022

Anticipated Study Completion Date :

Sep 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
medical workers medical workers of the resuscitation and intensive care unit of newborns	Other: work conditions 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

Arm

Intervention/Treatment

medical workers

medical workers of the resuscitation and intensive care unit of newborns

Other: work conditions

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

Outcome Measures

Primary Outcome Measures

Heart rate [8 hours]
bpm, "Armed": "YE-630A" (ТМ "ARMED", Russia)
Blood pressure [8 hours]
mm Hg, "Armed": "YE-630A" (ТМ "ARMED", Russia)
Anthropometry (Height) [1 hour]
Height (cm), weight (kg), Seca 703 ("Seca GMBH&Co", Germany)
Anthropometry (Weight) [1 hour]
Weight (kg), Seca 703 ("Seca GMBH&Co", Germany)
Body temperature [1 hour]
Celsius, Thermoval Standard ("PAUL HARTMANN", Germany)
Electrocardiography [1 hour]
Electrocardiogram analysis, Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)
Cognitive functions test 1 [1 hour]
Bourdon correction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
Cognitive functions test 2 [1 hour]
Simple visual-motor reaction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)
Cognitive functions test 3 [1 hour]
Growing account test. Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)

Secondary Outcome Measures

Survey [1 hour]
Subjective survey on functional state of the body (7 scales)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health	Moscow		Russian Federation	105275

Sponsors and Collaborators

Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"

Investigators

Principal Investigator: Inga Malakhova, Junior scientist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andrey Mikhailovich Geregey, Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"

ClinicalTrials.gov Identifier:

NCT05491148

Other Study ID Numbers:

PPE-06

First Posted:

Aug 8, 2022

Last Update Posted:

Aug 8, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andrey Mikhailovich Geregey, Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey, Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"

functional state of the body

medical personnel

heart rate variability

cognitive functions

cardiovascular system

Study Results

No Results Posted as of Aug 8, 2022