NCT04631497

Brief Summary

Medical personnel working in the Intensive Care Unit will be examined by means of tests. Their aim is to check how work-related stress in a potentially lethal threat affects the occurrence of depression, stress, anxiety and sleep disorders. We also want to check whether people working in such extremely difficult conditions show no greater interest in death.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

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

Study Start

First participant enrolled

July 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

November 9, 2020

Last Update Submit

June 2, 2022

Conditions

Keywords

Healthcare WorkersCOVID-19Mental Health Outcomes

Outcome Measures

Primary Outcomes (3)

  • Depression

    Beck's test the BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original: 0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression

    1 month

  • Stress

    Perceived Stress Scale (PSS) The PSS predicts both objective biological markers of stress and increased risk for disease among persons with higher perceived stress levels. For example, those with higher scores (suggestive of chronic stress) on the PSS fend worse on biological markers of aging, cortisol levels, immune markers, depression, infectious disease,wound healing, and prostate-specific antigen levels in men. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positivelystated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made fromquestions 2, 4, 5 and 10 of the PSS 10 item scale.

    1 month

  • Deal with Stress

    COPE test It is a self-written tool consisting of 60 statements, to which the respondent responds on a 4-point scale. It allows the assessment of 15 strategies for responding to stressful situations.

    1 month

Secondary Outcomes (1)

  • Stress 2

    1 month

Study Arms (1)

Healthcare workers

The study will cover employees of the Intensive Care Unit - nurses and doctors working with patients with COVID-19 infection. Test takers will be over the age of 18 and under the age of 70, female and male.

Diagnostic Test: test

Interventions

testDIAGNOSTIC_TEST

1. Beck's Test 2. Test STAI 3. Test PSS 4. the scale of the fascination with death 5. COPE

Healthcare workers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University Hospital in Cracow ICU depratment

You may qualify if:

  • adult employees of the Intensive Care Unit, agreeing to undergo the tests.

You may not qualify if:

  • patient's refusal to participate in the study
  • not understanding the test questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital in Cracow

Krakow, 31-501, Poland

Location

MeSH Terms

Conditions

DepressionCOVID-19

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Tomasz Skladzien, Ph.D. M.D.

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. M.D.

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 17, 2020

Study Start

July 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations