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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04689464
Other study ID # 1120
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date June 1, 2021

Study information

Verified date June 2021
Source AlFayhaa General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The covid-19 pandemic started to spread worldwide since December 2019. It promoted to an exaggerated psychological stress and anxiety in humans due to the intolerable symptoms higher than usual death of many infected patients. This study examines the corona related anxiety and if there is need for drug intervention to treat this anxiety. To answer these questions, a survey made to the hospitalized patients including sex, age, educational level, Marital state, and a standardized questionnaires (GAD-7 and PHQ-9) which has been validated and shown to possess good psychometric qualities in studies of participants from multiple populations.


Recruitment information / eligibility

Status Completed
Enrollment 450
Est. completion date June 1, 2021
Est. primary completion date May 28, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - patients with COVID19 willing to participate in the study Exclusion Criteria: - unwilling unable to read or interact with standardized questionnaire unconscious

Study Design


Locations

Country Name City State
Iraq AlFayhaa Teaching hospital Basra

Sponsors (3)

Lead Sponsor Collaborator
Alhasan Mujtaba Al-Mudhaffer Ministry of Health, Iraq, University of Basrah

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary depression Depression measured by Patient Health Questionnaire-9 (PHQ-9) scale. Scoring: 5-9 mild;10-14 moderate; 15-19 moderately severe; >20 severe. Minimum 0 maximum 27 points at the time of acute infection, average of 1 month
Primary anxiety Anxiety measured by General Anxiety Disorder-7 (GAD-7) scale. Scoring:5-9 mild; 10-14 moderate; >15 severe. Minimum 0, maximum 21 points at the time of acute infection, average of 1 month
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