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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04978220
Other study ID # 2020-021(BMR)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 27, 2020
Est. completion date May 31, 2021

Study information

Verified date July 2021
Source Peking University Sixth Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to clarify the severity of psychological problems and insomnia and the two's relationship with time of hospital medical staff in hospital where its staff are infected with COVID-19.


Description:

A cross-sectional questionnaire survey method was adopted to conduct investigations of medical staff in the researched hospital within one week (baseline) and one year (follow-up) after the discovery of COVID-19 infection cases. 360 subjects were included in the baseline. Then, after one year, 199 subjects who participated in the survey at baseline were included as follow-up. The HADS, ASDS and ISI scales were used to assess the anxiety and depression level, acute stress disorder symptoms, and the severity of insomnia of hospital medical staff; self-made questionnaires was to collect demographic information and descriptive content. Comparing the follow-up medical staff with the baseline, the total scores of ASDS, HADS and ISI, each item scores on the ASDS, HADS and ISI. All of above scales are compared between the quarantined and non-quarantined groups, different quarantined groups (home, hotel, hospital) and non-quarantined groups.


Recruitment information / eligibility

Status Completed
Enrollment 390
Est. completion date May 31, 2021
Est. primary completion date June 27, 2020
Accepts healthy volunteers No
Gender All
Age group 21 Years to 70 Years
Eligibility Inclusion Criteria: - all medical staff of a third-level general hospital in Beijing who discovered a sporadic case of COVID-19 infection; Volunteer to participate in surveys and follow-ups Exclusion Criteria: - Incomplete information fills in, which affects the result analysis

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Peking University Sixth Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Sixth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Insomnia Severity Index (Insomnia Severity Index, ISI) ISI is a simple tool for screening insomnia, including 7 items to assess the severity of the subjects' sleep symptoms, the subjects' satisfaction with their sleep patterns, the impact of the degree of insomnia on daily functions, the subjects' awareness of the impact of insomnia on themselves, and the level of depression caused by sleep disorders. 1 year
Primary Hospital Anxiety and Depression Scale (HADS) HADS is used to assess the anxiety and depression symptoms of medical staff in general hospitals. There are 14 items in total, divided into two parts-the anxiety subscale (HADS-A) and the depression subscale (HADS-D). A total score of 0-7 is classified as asymptomatic, 8-10 is classified as marginal/suspicious, and 11-21 is classified as abnormal. 1 year
Secondary Acute Stress Disorder Scale (ASDS) ASDS is a self-rating scale, compiled according to the diagnostic criteria of the fourth edition of the "Manual of Diagnosis and Statistics of Mental Disorders", used to assess acute stress disorder (ASD) symptoms and predict post-traumatic stress disorder (PTSD). 1 year
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