Occupational StressNCT04363229
Psychological Impact of COVID19 Among Doctors in Assiut University Hospitals
An observational study of Occupational Stress, run by Assiut University.
Trial summary
study aimed to investigate the psychological impact of corona virus among doctor in Assiut University Hospitals, mainly stress and burn out will be assessed Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Occupational Stress
- What is being tested?
- maslach burnout inventory questionnair
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jun 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 22 years and older
- All sexes
- Adult, Older adult
Study population: Doctors currently working in Assiut University Hospitals in all titles: resident doctors, assistant lecturer, lecturer, assistant professor and professor
Who may be able to join
- all doctors currently working in assiut University hospitals
Who cannot join
- no exclusion critiria
Trial locations and contacts
No sites are listed yet.
About this study
study aimed to investigate the psychological impact of corona virus among doctor in Assiut University Hospitals, mainly stress and burn out will be assessed
Read the detailed description
Prolonged exposure to stressful working environments resulting in a state of physical and emotional depletion and burnout. Nowadays, while facing corona virus, health care workers are on the front line and directly assist in diagnosis, caring and treatment of patients with COVID, thus keeping them at higher risk developing psychological distress and other mental health symptoms.
According to previous studies, during the outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), frontline medical staff had reported high levels of stress that resulted in posttraumatic stress disorder (PTSD)
A lot of factors contribute to increase mental effect among healthcare workers as increasing the suspected cases and workload , depletion of personal protective equipment's , drug shortage and feeling inadequately supported .
In Toronto study(2008), four major risk factors for stress among medical staff during the SARS outbreak were identified; including the perception of the medical of their risk of infection, the impact of SARS on their work, feelings of depression, and working in high-risk medical units. moreover, there are other factors as social stigmatization and contact with infected patients, also has previously been shown to be associated with increased levels of stress and anxiety in medical staff .
- Conditions
- Occupational Stress
- Being tested
- maslach burnout inventory questionnair
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maslach burnout inventory questionnairOther
Also called GHQ-12 questionnair
The Maslach Burnout Inventory (MBI) is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout
What is being measured
The primary outcome is the main question the study is designed to answer.
The MBI-HSS (MP) addresses three scales:Emotional Exhaustion ,Depersonalization and Personal Accomplishment
Emotional Exhaustion measures feelings of being emotionally overextended and exhausted by one's work.
Depersonalization measures an unfeeling and impersonal response toward patients.
Personal Accomplishment measures feelings of competence and successful achievement in one's work.
All MBI items are scored using a 7 level frequency scale from "never" to "daily." Initial development had 3 components: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout
Measured: baseline
Secondary outcomes (1)
GHQ-12 questionnaire for measuring of current mental health
The scale asks whether the respondent has experienced a particular symptom or behavior recently. Each item is rated on a four-point scale (less than usual, no more than usual, rather more than usual, or much more than usual); and for example when using the GHQ-12 it gives a total score of 36 or 12 based on the selected scoring methods.
it measure social dysfunction, anxiety and depression and loss of confidence
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study startJul 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational StressStudies 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
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Roshdy Elkhayat, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363229
- Sponsor's protocol ID
- pshycological impact COVID19
- Status last verified
- Jul 2020
- First submitted
- 23 Apr 2020
- Last updated
- 8 Jul 2020
- 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 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of COVID19 Among Doctors in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04363229
- Acronym / sponsor ID
- pshycological impact COVID19
- Conditions
- Occupational Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 27 Apr 2020 (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.
study aimed to investigate the psychological impact of corona virus among doctor in Assiut University Hospitals, mainly stress and burn out will be assessed
Detailed description
Prolonged exposure to stressful working environments resulting in a state of physical and emotional depletion and burnout. Nowadays, while facing corona virus, health care workers are on the front line and directly assist in diagnosis, caring and treatment of patients with COVID, thus keeping them at higher risk developing psychological distress and other mental health symptoms.
According to previous studies, during the outbreaks of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), frontline medical staff had reported high levels of stress that resulted in posttraumatic stress disorder (PTSD)
A lot of factors contribute to increase mental effect among healthcare workers as increasing the suspected cases and workload , depletion of personal protective equipment's , drug shortage and feeling inadequately supported .
In Toronto study(2008), four major risk factors for stress among medical staff during the SARS outbreak were identified; including the perception of the medical of their risk of infection, the impact of SARS on their work, feelings of depression, and working in high-risk medical units. moreover, there are other factors as social stigmatization and contact with infected patients, also has previously been shown to be associated with increased levels of stress and anxiety in medical staff .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Doctors currently working in Assiut University Hospitals in all titles: resident doctors, assistant lecturer, lecturer, assistant professor and professor
Key inclusion criteria (1 listed)
- all doctors currently working in assiut University hospitals
Key exclusion criteria (1 listed)
- no exclusion critiria
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 |
|---|---|---|
| maslach burnout inventory questionnairAlso: GHQ-12 questionnairThe Maslach Burnout Inventory (MBI) is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout | Other | – |
Primary outcome
The MBI-HSS (MP) addresses three scales:Emotional Exhaustion ,Depersonalization and Personal Accomplishment
Time frame: baseline
Emotional Exhaustion measures feelings of being emotionally overextended and exhausted by one's work. Depersonalization measures an unfeeling and impersonal response toward patients. Personal Accomplishment measures feelings of competence and successful achievement in one's work. All MBI items are scored using a 7 level frequency scale from "never" to "daily." Initial development had 3 components: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout
1 secondary outcome
GHQ-12 questionnaire for measuring of current mental health
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Psychological Impact and Coping Strategies of Frontline Medical Staff in Hunan Between January and March 2020 During the Outbreak of Coronavirus Disease 2019 (COVID-19) in Hubei, ChinaLink provided by the sponsor.
- The emotional impact of Coronavirus 2019-nCoV (newCoronavirusdisease)Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Stress, 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 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 8 Jul 2020. 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?
Contact mariam elkhayat, MD (00201003708261 ext. 00201003708261, mariam.elkhayat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The MBI-HSS (MP) addresses three scales:Emotional Exhaustion ,Depersonalization and Personal Accomplishment (time frame: baseline). 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 8 Jul 2020.