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Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04631497
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Tomasz Skladzien, Jagiellonian University

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.

Condition or disease Intervention/treatment
Depression Diagnostic Test: test

Detailed Description:

Every day medical staff working in very difficult conditions of intensive care. The COVID-19 virus outbreak has set another difficult task for doctors and nurses who have previously had a lot of contact with the death of their patients. The appearance of the COVID-19 virus and, above all, the inability to effectively treat the infection causes an additional psychological stimulus in medical personnel.

The aim of the study is to assess the occurrence of psychiatric disorders in medical personnel dealing with patients suffering from COVID-19 using various psychological tests.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
  1. Beck's Test
  2. Test STAI
  3. Test PSS
  4. the scale of the fascination with death
  5. COPE




Primary Outcome Measures :
  1. Depression [ Time Frame: 1 month ]

    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


  2. Stress [ Time Frame: 1 month ]

    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.


  3. Deal with Stress [ Time Frame: 1 month ]
    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.


Secondary Outcome Measures :
  1. Stress 2 [ Time Frame: 1 month ]
    the scale of the fascination with death The Death Obsession Scale (DOS) was made by Abdel-Khalek. It was intended to be a main component in the death distress const.ruct: death anxiety, death depression, and death obsession. The DOS assesses a multidimensional trait. It is responded to on a five-point Likert-type rating scale as follows: No (1), A little (2), A fair amount (3), Much (4) and Very much (5). The total score can range from 15 to 75.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
University Hospital in Cracow ICU depratment
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04631497


Contacts
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Contact: Tomasz Skladzien, Ph.D. M.D +48506602250 ext +48 t.skladzien@interia.pl
Contact: Tomasz Skladzien, Ph.D. M.D. +48506602250 ext +48 t.skladzien@interia.pl

Locations
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Poland
University Hospital in Cracow Recruiting
Kraków, Poland, 31-501
Contact: Tomasz Skladzien, PhD    506602250 ext +48    t.skladzien@interia.pl   
Sponsors and Collaborators
Jagiellonian University
Investigators
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Principal Investigator: Tomasz Skladzien, Ph.D. M.D. Jagiellonian University
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Responsible Party: Tomasz Skladzien, Ph.D. M.D., Jagiellonian University
ClinicalTrials.gov Identifier: NCT04631497    
Other Study ID Numbers: 1072.6120.161.2020
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomasz Skladzien, Jagiellonian University:
Healthcare Workers
COVID-19
Mental Health Outcomes
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders