NCT05491148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

1 month

First QC Date

August 4, 2022

Last Update Submit

May 13, 2023

Conditions

Keywords

functional state of the bodymedical personnelheart rate variabilitycognitive functionscardiovascular system

Outcome Measures

Primary Outcomes (9)

  • Heart rate

    bpm, "Armed": "YE-630A" (ТМ "ARMED", Russia)

    8 hours

  • Blood pressure

    mm Hg, "Armed": "YE-630A" (ТМ "ARMED", Russia)

    8 hours

  • Anthropometry (Height)

    Height (cm), weight (kg), Seca 703 ("Seca GMBH\&Co", Germany)

    1 hour

  • Anthropometry (Weight)

    Weight (kg), Seca 703 ("Seca GMBH\&Co", Germany)

    1 hour

  • Body temperature

    Celsius, Thermoval Standard ("PAUL HARTMANN", Germany)

    1 hour

  • Electrocardiography

    Electrocardiogram analysis, Electrocardiographic system "Poly-Specter-SM" (LLC "Neurosoft", Russia)

    1 hour

  • Cognitive functions test 1

    Bourdon correction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)

    1 hour

  • Cognitive functions test 2

    Simple visual-motor reaction test, Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)

    1 hour

  • Cognitive functions test 3

    Growing account test. Universal psychodiagnostic complex NS-Psychotest (LLC "Neurosoft", Russia)

    1 hour

Secondary Outcomes (1)

  • Survey

    1 hour

Study Arms (1)

medical workers

medical workers of the resuscitation and intensive care unit of newborns

Other: work conditions

Interventions

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

medical workers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy medical workers in neonatal intensive care unit

You may qualify if:

  • the volunteer has practical experience in the neonatal intensive care unit
  • digestive tract, kidney, cardiorespiratory system, mervous system or musculoskeletal system pathology

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health

Moscow, 105275, Russia

Location

MeSH Terms

Interventions

Working Conditions

Intervention Hierarchy (Ancestors)

WorkplaceEmploymentSocioeconomic FactorsPopulation CharacteristicsPersonnel ManagementOrganization and AdministrationHealth Services Administration

Study Officials

  • Inga Malakhova

    Junior scientist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

August 29, 2022

Primary Completion

October 5, 2022

Study Completion

October 10, 2022

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations