- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04978220
Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital With Infected COVID-19 Patients
July 22, 2021 updated by: Xueqin Wang, Peking University Sixth Hospital
Follow-up Study on Mental and Psychological Problems and Insomnia Disorder of Medical Staff in Hospital Where Staff Are Infected With COVID-19
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
390
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Peking University Sixth Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
There were 644 medical staff on duty in the hospital, of which 360 people participated in the baseline survey, accounting for 55.90%.
In the follow-up survey after one year, 199 out of 360 people in the baseline participated, accounting for 55.28% of the baseline.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 1 year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Stress Disorder Scale (ASDS)
Time Frame: 1 year
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index (Insomnia Severity Index, ISI)
Time Frame: 1 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xueqin Wang, MD, Peking University Sixth Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2020
Primary Completion (Actual)
June 27, 2020
Study Completion (Actual)
May 31, 2021
Study Registration Dates
First Submitted
July 19, 2021
First Submitted That Met QC Criteria
July 22, 2021
First Posted (Actual)
July 27, 2021
Study Record Updates
Last Update Posted (Actual)
July 27, 2021
Last Update Submitted That Met QC Criteria
July 22, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-021(BMR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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