Psychological Impact of Covid-19NCT04789226
Psychological Impact of Covid-19 Assiut University Hospital Experience
An observational study of Psychological Impact of Covid-19, run by Assiut University.
Trial summary
Psychological impact of covid-19 in assiut university hospital Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Psychological Impact of Covid-19
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients more than 18 years old and less than 90 years old diagnosed as covid-19 by positive PCR
Who may be able to join
- age more than 18 years old
- diagnosed as covid-19 by positive PCR
- comes to Assiut University Hospital
- both sex males and females
Who cannot join
- age less than 18 years old
- past history of psychatric disorder
About this study
Psychological impact of covid-19 in assiut university hospital
Read the detailed description
Coronavirus disease 2019 (COVID-19) is a new communicable disease caused by the new strains of severe acute respiratory syndrome coronavirus, SARS-CoV-2 . The first outbreak reported was in December2019, in Wuhan, China, as pneumonia of unknown etiology linked to a seafood market exposure COVID-19 affects different people in different ways. Most infected people will develop mild to moderate illness and recover without hospitalization.
The evolution of the novel Corona Virus Disease (COVID-19) and its expeditious dissemination have led the World Health Organization (WHO) to declare it a pandemic on 11 March 2020 . As of 16 May 2020, there have been 4,425,485 confirmed COVID-19 cases and 302,059 related deaths worldwide and Egypt has been among the most affected countries in the Eastern Mediterranean region with 11,228 confirmed cases and 592 deaths .
As a consequence, many countries, including Egypt, have set a state of lockdown to hinder the spread of infection among people resulting in a global atmosphere of depression and anxiety associated with social isolation, fears of getting infected, breaks in the supply chains, financial distress, disrupted travel plans, and future uncertainty . Several epidemiological studies from China detected a high prevalence of psychological disturbances among the public during the COVID-19 pandemic. For example, a large online survey of 56,679 individuals from 34 provinces in China reported numerous psychological conditions during the COVID-19 pandemic: depression (27.9%), anxiety (31.6%), stress (24.4%), and insomnia (29.2%) . Also, a study conducted on 4872 Chinese people from 31 provinces showed a high prevalence of depression (48.3%) and anxiety (22.6%) related to the COVID-19 pandemic . A similar study revealed depression (20.1%), anxiety (35.1%), and poor sleeping (18.2%) among 7236 Chinese people . Another study conducted on 7143 college students in China detected anxiety among 25% of them .
In low- and middle-income countries, such as Egypt, where infection control precautions, surveillance programs, laboratory capacity, and public health resources are limited , the response to the COVID-19 pandemic is challenging and, as a result, the psychological impacts of the pandemic on the public can be even worse. Thus, we conducted this study to evaluate several forms of psychological disturbances .
- Conditions
- Psychological Impact of Covid-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Checklist 90 "SCL 90"
it is a 90 item questionnaire used to assess psychological problems .
Measured: One year
post traumatic stress disorder "PTSD"
PCL-5 is a 20 item self report measure that assesses the 20 DSM-5 symptoms of PTSD .
Measured: One year
Pittsburgh Sleep Quality Index "PSQI"
evaluating sleep quality in older adults , the pittsburgh sleep quality index can be used to detect sleep disturbance or deficits .
Measured: One year
The 36- items Short Form"SF 36"
consists of eight scaled scores , which are the weighted sums of the questions in their section " evaluating individual patients health status " .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Impact of Covid-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 239 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Yassin Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789226
- Sponsor's protocol ID
- Psychology and covid 19
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of Covid-19 Assiut University Hospital Experience
- ClinicalTrials.gov ID
- NCT04789226
- Acronym / sponsor ID
- Psychology and covid 19
- Conditions
- Psychological Impact of Covid-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 239 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psychological impact of covid-19 in assiut university hospital
Detailed description
Coronavirus disease 2019 (COVID-19) is a new communicable disease caused by the new strains of severe acute respiratory syndrome coronavirus, SARS-CoV-2 . The first outbreak reported was in December2019, in Wuhan, China, as pneumonia of unknown etiology linked to a seafood market exposure COVID-19 affects different people in different ways. Most infected people will develop mild to moderate illness and recover without hospitalization.
The evolution of the novel Corona Virus Disease (COVID-19) and its expeditious dissemination have led the World Health Organization (WHO) to declare it a pandemic on 11 March 2020 . As of 16 May 2020, there have been 4,425,485 confirmed COVID-19 cases and 302,059 related deaths worldwide and Egypt has been among the most affected countries in the Eastern Mediterranean region with 11,228 confirmed cases and 592 deaths .
As a consequence, many countries, including Egypt, have set a state of lockdown to hinder the spread of infection among people resulting in a global atmosphere of depression and anxiety associated with social isolation, fears of getting infected, breaks in the supply chains, financial distress, disrupted travel plans, and future uncertainty . Several epidemiological studies from China detected a high prevalence of psychological disturbances among the public during the COVID-19 pandemic. For example, a large online survey of 56,679 individuals from 34 provinces in China reported numerous psychological conditions during the COVID-19 pandemic: depression (27.9%), anxiety (31.6%), stress (24.4%), and insomnia (29.2%) . Also, a study conducted on 4872 Chinese people from 31 provinces showed a high prevalence of depression (48.3%) and anxiety (22.6%) related to the COVID-19 pandemic . A similar study revealed depression (20.1%), anxiety (35.1%), and poor sleeping (18.2%) among 7236 Chinese people . Another study conducted on 7143 college students in China detected anxiety among 25% of them .
In low- and middle-income countries, such as Egypt, where infection control precautions, surveillance programs, laboratory capacity, and public health resources are limited , the response to the COVID-19 pandemic is challenging and, as a result, the psychological impacts of the pandemic on the public can be even worse. Thus, we conducted this study to evaluate several forms of psychological disturbances .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients more than 18 years old and less than 90 years old diagnosed as covid-19 by positive PCR
Key inclusion criteria (4 listed)
- age more than 18 years old
- diagnosed as covid-19 by positive PCR
- comes to Assiut University Hospital
- both sex males and females
Key exclusion criteria (2 listed)
- age less than 18 years old
- past history of psychatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom Checklist 90 "SCL 90"
Time frame: One year
it is a 90 item questionnaire used to assess psychological problems .
post traumatic stress disorder "PTSD"
Time frame: One year
PCL-5 is a 20 item self report measure that assesses the 20 DSM-5 symptoms of PTSD .
Pittsburgh Sleep Quality Index "PSQI"
Time frame: One year
evaluating sleep quality in older adults , the pittsburgh sleep quality index can be used to detect sleep disturbance or deficits .
The 36- items Short Form"SF 36"
Time frame: one year
consists of eight scaled scores , which are the weighted sums of the questions in their section " evaluating individual patients health status " .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Impact of Covid-19, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Checklist 90 "SCL 90" (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.