Cross Sectional Hospital Based StudyNCT04861272
Risk Perception Associated With Covid-19 Among Anesthetists
An observational study of Cross Sectional Hospital Based Study, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Since the outbreak of the COVID-19 pandemic, the anesthesiologists are involved in the riskiest interventions e.g. airway management, endotracheal intubation, and resuscitation. So, they are subjected to a higher risk of infection compared to many other medical specialties. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cross Sectional Hospital Based Study
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Apr 2021to 15 May 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Participants' demographic variables such as gender, age, years of experience, educational degree, position at the hospital, unit of work and hospital type. * Outcome variables: The prevalence of Anxiety, Depression and Posttraumatic Stress Disorder (PTSD)
Who may be able to join
- The survey included anesthesia physicians, anesthesia technicians and nurses, and those involved in the management of COVID-19 infected patients in the OR, ICU, or ER.
Who cannot join
- The exclusion criteria include age < 18 or > 60 years, incomplete data, or those who were outside Saudi Arabia during the time of the COVID-19 pandemic.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Salah N. El-Tallawy
Riyadh, 7805
SALAH N. EL-TALLAWY, 0114692191
About this study
Official title: RISK PERCEPTION ASSOCIATED WITH COVID-19 PANDEMIC AMONG ANESTHETISTS: A Cross-Sectional Study
Since the outbreak of the COVID-19 pandemic, the anesthesiologists are involved in the riskiest interventions e.g. airway management, endotracheal intubation, and resuscitation. So, they are subjected to a higher risk of infection compared to many other medical specialties. As a result, they are more subjected to psychological stresses. This study aimed to assess the level of stress associated with the COVID-19 pandemic among anesthesiologists.
Read the detailed description
This is a cross-sectional, hospital-based survey conducted using an online questionnaire after getting IRB approval. The primary outcomes are to evaluate the prevalence of anxiety, depression, and post-traumatic stress disorder (PTSD) among anesthesiologists working in Saudi Arabia. The secondary outcomes include the association of the socio-demographic and occupational characteristics with mental health in the study sample. The survey sent to the target participants using a web-based software platform (https://www.surveymonkey.com/r/ZJ98BTJ) though the Saudi Society of Anesthesia. The study sample included anesthetists and their allied health care providers (nurses and technicians) involved in the management of COVID-19 patients. Data were analyzed using SPSS version 21. Descriptive analyses were conducted, and the ranked data for each level for symptoms of depression, anxiety, and PTSD were presented as numbers and percentages. Multi-variable logistic regression analysis was used to explore potential influence factors on the outcomes. P-values of less than 0.05 were considered statistically significant.
- Conditions
- Cross Sectional Hospital Based Study
- Being tested
- Survey
- Keywords
- COVID-19 pandemic, Anesthetists, Psychological stress, Anxiety, Depression, PTSD
- Medical subject headings
- COVID-19, Stress, Psychological, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Online survey
What is being measured
The primary outcome is the main question the study is designed to answer.
- The prevalence of Anxiety, Depression, and Posttraumatic Stress Disorder (PTSD) among anesthesiologists during COVID-19 pandemic.
Online survey
Measured: 2 weeks
Secondary outcomes (1)
- Comparison of the prevalence of anxiety, depression, and level of stress among different groups e.g. males # females, different occupations, single # married, young, middle-aged # geriatrics
Online survey
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start15 Apr 2021
- Primary completion5 May 2021 (estimated)
- Study completion15 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross Sectional Hospital Based StudyStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SALAH EL-TALLAWY, King Saud University
- Investigators
- SALAH N. EL-TALLAWY, MD, Principal investigator, KING SAUD UNIVERSITY, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861272
- Sponsor's protocol ID
- IRB approval No. E-20-4975
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISK PERCEPTION ASSOCIATED WITH COVID-19 PANDEMIC AMONG ANESTHETISTS: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04861272
- Acronym / sponsor ID
- IRB approval No. E-20-4975
- Conditions
- Cross Sectional Hospital Based Study
- Keywords
- COVID-19 pandemic, Anesthetists, Psychological stress, Anxiety, Depression, PTSD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 5 May 2021 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 27 Apr 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.
Since the outbreak of the COVID-19 pandemic, the anesthesiologists are involved in the riskiest interventions e.g. airway management, endotracheal intubation, and resuscitation. So, they are subjected to a higher risk of infection compared to many other medical specialties. As a result, they are more subjected to psychological stresses. This study aimed to assess the level of stress associated with the COVID-19 pandemic among anesthesiologists.
Detailed description
This is a cross-sectional, hospital-based survey conducted using an online questionnaire after getting IRB approval. The primary outcomes are to evaluate the prevalence of anxiety, depression, and post-traumatic stress disorder (PTSD) among anesthesiologists working in Saudi Arabia. The secondary outcomes include the association of the socio-demographic and occupational characteristics with mental health in the study sample. The survey sent to the target participants using a web-based software platform (https://www.surveymonkey.com/r/ZJ98BTJ) though the Saudi Society of Anesthesia. The study sample included anesthetists and their allied health care providers (nurses and technicians) involved in the management of COVID-19 patients. Data were analyzed using SPSS version 21. Descriptive analyses were conducted, and the ranked data for each level for symptoms of depression, anxiety, and PTSD were presented as numbers and percentages. Multi-variable logistic regression analysis was used to explore potential influence factors on the outcomes. P-values of less than 0.05 were considered statistically significant.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Participants' demographic variables such as gender, age, years of experience, educational degree, position at the hospital, unit of work and hospital type. * Outcome variables: The prevalence of Anxiety, Depression and Posttraumatic Stress Disorder (PTSD)
Key inclusion criteria (1 listed)
- The survey included anesthesia physicians, anesthesia technicians and nurses, and those involved in the management of COVID-19 infected patients in the OR, ICU, or ER.
Key exclusion criteria (1 listed)
- The exclusion criteria include age < 18 or > 60 years, incomplete data, or those who were outside Saudi Arabia during the time of the COVID-19 pandemic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyOnline survey | Behavioural | – |
Primary outcome
- The prevalence of Anxiety, Depression, and Posttraumatic Stress Disorder (PTSD) among anesthesiologists during COVID-19 pandemic.
Time frame: 2 weeks
Online survey
1 secondary outcome
- Comparison of the prevalence of anxiety, depression, and level of stress among different groups e.g. males # females, different occupations, single # married, young, middle-aged # geriatrics
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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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.
SALAH N. EL-TALLAWY, MD principal investigator
KING SAUD UNIVERSITY, Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cross Sectional Hospital Based Study, run by King Saud University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact SALAH N. EL-TALLAWY, MD (+966557931195, salaheltallawy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- The prevalence of Anxiety, Depression, and Posttraumatic Stress Disorder (PTSD) among anesthesiologists during COVID-19 pandemic. (time frame: 2 weeks). 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 27 Apr 2021.