AnxietyNCT05212909
Anxiety Level Assessment of Anesthesia Providers During COVID-19 Pandemic
An observational study of Anxiety, run by Augusta University at 1 site in United States.
Trial summary
Healthcare providers caring for acutely ill or critical patients are exposed to constant stressful situations that can lead to psychiatric manifestations. Depression and anxiety derived from stressful work environments can negatively impact the ability to perform at full capacity directly affecting the quality of care… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- General Anxiety Disorder-7 scale
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Sep 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Anesthesiology providers at Augusta University Medical Center
Who may be able to join
- Anesthesiology providers at Augusta University Medical Center (AU) (Active resident enrolled in the Anesthesiology residency program of Augusta University, Anesthesiologist and Certified Registered Nurse Anesthetist)
- Willingness to participate in the study
Who cannot join
- Refuses to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Augusta University Medical Center
Augusta, Georgia, 30912
About this study
Healthcare providers caring for acutely ill or critical patients are exposed to constant stressful situations that can lead to psychiatric manifestations. Depression and anxiety derived from stressful work environments can negatively impact the ability to perform at full capacity directly affecting the quality of care the patients receive.
The Severe Acute Respiratory Syndrome Coronavirus 2 infection created a sudden and deep crisis involving every sector worldwide not only affecting sick patients and the healthcare system but also the economy, politics, food, and drugs and social interactions.
Read more
Hospital workers have experienced the crisis first-hand and have witnessed constant death, a decrease in personal protective equipment supplies, exposure to contracting the virus, risk of contagion to others, and overburdened hospital capacity.
The aim of this study is to evaluate how the coronavirus disease 2019 (COVID-19) pandemic has affected healthcare workers. Specifically, to evaluate levels of anxiety and identify factors contributing to anxiety on faculty, residents, and nurse anesthetists in our institution.
Read the detailed description
The coronavirus disease 2019 (COVID-19) pandemic has affected multiple aspects of everyday life worldwide. Pandemics unleash a societal sense of fear and anxiety. Hence, the COVID-19 pandemic have had a profound impact on mental health. This has led to substantial research on this topic; however, literature evaluating the mental health effects of the pandemic on small groups of people is scarce. Healthcare workers have undergone significant psychological pressure and stress during viral surges of this pandemic. Furthermore, the levels of anxiety vary as the number of cases varies between regions and across time.
After approval by the Institutional Review Board (Protocol # 160167), a cross-sectional study was conducted to identify anxiety levels during the COVID-19 pandemic among anesthesia providers at our institution. The participants included Faculty anesthesiologists, anesthesiology residents, Certified Registered Nurse Anesthetists, and Nurse Anesthetists students. Data were collected from August 26 to September 15, 2020. A questionnaire containing the General Anxiety Disorder-7 (GAD-7) scale, followed by a set of questions with binary answers to evaluate the presence or absence of anxiety-related factors during the COVID-19 pandemic, was administered through direct approach and voluntary participation of the subjects.
- Conditions
- Anxiety
- Being tested
- General Anxiety Disorder-7 scale
- Keywords
- Anxiety, Mental health, COVID-19, Coronavirus
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being, COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anxiety Disorder-7 scaleBehavioural
The General Anxiety Disorder-7 scale was used to evaluate the level of anxiety in anesthesiology providers.
What is being measured
The primary outcome is the main question the study is designed to answer.
The anxiety levels on anesthesia providers measured by the General Anxiety Disorder 7 scale during COVID-19 pandemic.
General Anxiety Disorder 7 scale was used to measure anxiety levels.
Measured: one month
Secondary outcomes (1)
The association between specific factors such as level of training, occupation, age and gender and the presence of anxiety.
Specific factors and the association with the presence of anxiety was evaluated.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Aug 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Efrain Riveros-Perez, MD. MBA., Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212909
- Sponsor's protocol ID
- 1601067
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 23 Feb 2022
- 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 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety Level Assessment of Anesthesia Providers During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05212909
- Acronym / sponsor ID
- 1601067
- Conditions
- Anxiety
- Keywords
- Anxiety, Mental health, COVID-19, Coronavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 28 Jan 2022 (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.
Healthcare providers caring for acutely ill or critical patients are exposed to constant stressful situations that can lead to psychiatric manifestations. Depression and anxiety derived from stressful work environments can negatively impact the ability to perform at full capacity directly affecting the quality of care the patients receive.
The Severe Acute Respiratory Syndrome Coronavirus 2 infection created a sudden and deep crisis involving every sector worldwide not only affecting sick patients and the healthcare system but also the economy, politics, food, and drugs and social interactions.
Hospital workers have experienced the crisis first-hand and have witnessed constant death, a decrease in personal protective equipment supplies, exposure to contracting the virus, risk of contagion to others, and overburdened hospital capacity.
The aim of this study is to evaluate how the coronavirus disease 2019 (COVID-19) pandemic has affected healthcare workers. Specifically, to evaluate levels of anxiety and identify factors contributing to anxiety on faculty, residents, and nurse anesthetists in our institution.
Detailed description
The coronavirus disease 2019 (COVID-19) pandemic has affected multiple aspects of everyday life worldwide. Pandemics unleash a societal sense of fear and anxiety. Hence, the COVID-19 pandemic have had a profound impact on mental health. This has led to substantial research on this topic; however, literature evaluating the mental health effects of the pandemic on small groups of people is scarce. Healthcare workers have undergone significant psychological pressure and stress during viral surges of this pandemic. Furthermore, the levels of anxiety vary as the number of cases varies between regions and across time.
After approval by the Institutional Review Board (Protocol # 160167), a cross-sectional study was conducted to identify anxiety levels during the COVID-19 pandemic among anesthesia providers at our institution. The participants included Faculty anesthesiologists, anesthesiology residents, Certified Registered Nurse Anesthetists, and Nurse Anesthetists students. Data were collected from August 26 to September 15, 2020. A questionnaire containing the General Anxiety Disorder-7 (GAD-7) scale, followed by a set of questions with binary answers to evaluate the presence or absence of anxiety-related factors during the COVID-19 pandemic, was administered through direct approach and voluntary participation of the subjects.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anesthesiology providers at Augusta University Medical Center
Key inclusion criteria (2 listed)
- Anesthesiology providers at Augusta University Medical Center (AU) (Active resident enrolled in the Anesthesiology residency program of Augusta University, Anesthesiologist and Certified Registered Nurse Anesthetist)
- Willingness to participate in the study
Key exclusion criteria (1 listed)
- Refuses to participate
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 |
|---|---|---|
| General Anxiety Disorder-7 scaleThe General Anxiety Disorder-7 scale was used to evaluate the level of anxiety in anesthesiology providers. | Behavioural | – |
Primary outcome
The anxiety levels on anesthesia providers measured by the General Anxiety Disorder 7 scale during COVID-19 pandemic.
Time frame: one month
General Anxiety Disorder 7 scale was used to measure anxiety levels.
1 secondary outcome
The association between specific factors such as level of training, occupation, age and gender and the presence of anxiety.
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- 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.
Efrain Riveros-Perez, MD. MBA. principal investigator
Augusta University
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 Anxiety, run by Augusta University at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 23 Feb 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The anxiety levels on anesthesia providers measured by the General Anxiety Disorder 7 scale during COVID-19 pandemic. (time frame: one month). 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 23 Feb 2022.