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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04368312
Other study ID # TEMP553914-BO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 6, 2020
Est. completion date December 30, 2020

Study information

Verified date May 2021
Source University Hospital, Essen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hospital staff and emergency personnel are expected to suffer impaired psychological outcomes during a pandemic in terms of Quality of Life, anxiety, depression or other outcomes. The Covid-19 pandemic is a threat for both somatic and psychological health, therefore the impact of the impairment of this event on psychological parameters has to be assessed.


Description:

Hospital staff and emergency personell are confronted with severe and life-threatening situations, therefore this group is considered to be at risk for impaired psychological health. A pandemic such as the Covid-19 endemic is suggested to severely impair the psychological state of this profession, amongst others Quality of life, anxiety, depression and other parameters. Therefore, it is crucial to assess the impact of impairment due to this global threat on the psychological health of health care providers. We therefore designed this study to evaluate baseline psychological characteristics and to re-assess those values in an interval of 60 days.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Hospital staff (doctors and nurses) Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention, just of questionnaire including validated tests

Locations

Country Name City State
Germany University Hospital Essen Essen NRW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary PCL5 Questionnaire Validated 20-items questionnaire for PTSD 14 days
Primary BSI - Brief symptom inventory The Brief Symptom Inventory (BSI) is a 53-item screener for mental health problems with 9 subscales. 14 days
Primary PHQD Instrument for psychological diagnostics, able to test the severity of mental disorders and the success of their treatment 14 days
Primary WHO - QoL BREF Qol Questionnaire, assessed QoL with respect to the individual's perceptions in the context of culture and value systems. 14 days
Primary STAXI The State-Trait Anger Expression Inventory is used to measure the expressions & control of anger 14 days
Primary AUDIT questionnaire The AUDIT questionnaire is designed to help in the self assessment of alcohol consumption 14 days
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