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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04506515
Other study ID # COV2-2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 9, 2020
Est. completion date April 30, 2020

Study information

Verified date November 2021
Source Hospital General Universitario de Valencia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited. Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional 45-item survey between 9 and 19 April 2020. The objective is to assess the psychological impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and Adaptation at work Score (PSAS) was defined combining four modified versions of validated psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.


Description:

PSAS (Psychological Stress and Adaptation at work Score) is a self conducted questionnaire designed to assess psychological impact in healthcare workers to match times of crisis and when the time is scarce. PSAS has a range between 0 and 105, and higher scores represent higher stress detected.


Recruitment information / eligibility

Status Completed
Enrollment 3000
Est. completion date April 30, 2020
Est. primary completion date April 19, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Active healthcare workers in any private/public hospital > 18 years old Exclusion Criteria: - Refusal to participate

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Psychological stress and adaptation at work score (PSAS)
completing a survey based on PSAS

Locations

Country Name City State
Spain CHGUV Valencia

Sponsors (1)

Lead Sponsor Collaborator
Hospital General Universitario de Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Romero CS, Delgado C, Catalá J, Ferrer C, Errando C, Iftimi A, Benito A, de Andrés J, Otero M; PSIMCOV group*. COVID-19 psychological impact in 3109 healthcare workers in Spain: The PSIMCOV group. Psychol Med. 2020 May 14:1-7. doi: 10.1017/S0033291720001671. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary PSAS (Psychological Stress and Adaptation at work Score) during the crisis evaluate the severity of psychological impact of the pandemic in Spain in healthcare workers during the pandemic (April 9, 2020 to April 19, 2020)
Secondary PSAS (Psychological Stress and Adaptation at work Score) in basal conditions evaluate the psychological stress in Spain in healthcare workers After the pandemic (back to regular activity to be considered in the future as we do not know it yet. It expected to be in less than one year.
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