Physical StressSURG-SAT-19NCT04433286
COVID-19 - Implications on Surgeons' Burnout and Career Satisfaction
An observational study of Physical Stress and Career Burnout, run by Mansoura University at 1 site in Egypt.
Trial summary
This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Stress, Career Burnout, Satisfaction
- What is being tested?
- Questionnaire
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2020to 31 Aug 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: Surgeons of all specialities; Cardiothoracic, General, Neurosurgery, Oral and Maxillofacial, Otolaryngology, Pediatric, Plastic, Trauma and Orthopedic, Urology, and Vascular Surgery. Furthermore, Gynecological Oncology and Urogynecology surgeons are invited. Both sex. All over the globe. Any level of experiences.
Who may be able to join
- The Survey is targeting surgeons of all specialities; Cardiothoracic, General, Neurosurgery, Oral and Maxillofacial, Otolaryngology, Pediatric, Plastic, Trauma and Orthopedic, Urology, and Vascular Surgery. Furthermore, Gynecological Oncology and Urogynecology surgeons are invited.
Who cannot join
- other specialities other than surgery
Trial locations and contacts
1 site in 1 country.
About this study
This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous.
The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice.
Read the detailed description
This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. A subsequent translation in different Language will provided based on geographical distribution. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous.
The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice.
Statistical analyses will be performed using SPSS v. 20. Data distribution will be tested for normality using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Categorical variables will be expressed as group percentages and will be compared for independent samples using the Chi-square test. Continuous data of the survey will be presented as medians with ranges or means and standard deviations. A comparison of continuous data will be compared for independent samples using the T-test or Mann-Whitney test according to the data distribution. Spearman correlation coefficient will be used for further assessment of the strength of the association between variables. The statistical significance level will be set at <0.05.
- Conditions
- Physical Stress, Career Burnout, Satisfaction
- Being tested
- Questionnaire
- Medical subject headings
- Burnout, Professional, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. A subsequent translation in different Language will provided based on geographical distribution. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous.
The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Burnout before COVID-19 and during COVID-19
A questionnaire designed based on the literature review to assess Burnout
Measured: 1 year before COVID-19 versus during the COVID-19 pandemic (Mrach-June 2020)
Change in Job satisfaction before COVID-19 and during COVID-19
A questionnaire designed based on the literature review to assess Job satisfaction
Measured: 1 year before COVID-19 versus during the COVID-19 pandemic (Mrach-June 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 Jun 2020 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical StressStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa shalaby, MD, MSc, PhD, Mansoura University
- Investigators
- Mostafa Shalaby, MD, MSc, PhD, Principal investigator, Mansoura Faculty of MedicineHosam Hamed, MD, MSc, PhD, Study chair, Mansoura Faculty of MedicineAhmed M Elsheikh, MD,MBA,CMQOE, Study director, Security Forces Program Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433286
- Sponsor's protocol ID
- SURG RES COL 1
- Acronym
- SURG-SAT-19
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shalaby M, ElSheikh AM, Hamed H; SURG-SAT-19 Collaborative Group. Burnout among surgeons before and during the SARS-CoV-2 pandemic: an international survey. BMC Psychol. 2024 Jan 25;12(1):48. doi: 10.1186/s40359-023-01517-4.
PubMed 38273390
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 - Implications on Surgeons' Burnout and Career Satisfaction
- ClinicalTrials.gov ID
- NCT04433286
- Acronym / sponsor ID
- SURG-SAT-19 / SURG RES COL 1
- Conditions
- Physical Stress, Career Burnout, Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 16 Jun 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.
This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous.
The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice.
Detailed description
This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. A subsequent translation in different Language will provided based on geographical distribution. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous.
The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice.
Statistical analyses will be performed using SPSS v. 20. Data distribution will be tested for normality using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Categorical variables will be expressed as group percentages and will be compared for independent samples using the Chi-square test. Continuous data of the survey will be presented as medians with ranges or means and standard deviations. A comparison of continuous data will be compared for independent samples using the T-test or Mann-Whitney test according to the data distribution. Spearman correlation coefficient will be used for further assessment of the strength of the association between variables. The statistical significance level will be set at <0.05.
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
- Surgeons of all specialities; Cardiothoracic, General, Neurosurgery, Oral and Maxillofacial, Otolaryngology, Pediatric, Plastic, Trauma and Orthopedic, Urology, and Vascular Surgery. Furthermore, Gynecological Oncology and Urogynecology surgeons are invited. Both sex. All over the globe. Any level of experiences.
Key inclusion criteria (1 listed)
- The Survey is targeting surgeons of all specialities; Cardiothoracic, General, Neurosurgery, Oral and Maxillofacial, Otolaryngology, Pediatric, Plastic, Trauma and Orthopedic, Urology, and Vascular Surgery. Furthermore, Gynecological Oncology and Urogynecology surgeons are invited.
Key exclusion criteria (1 listed)
- other specialities other than surgery
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 |
|---|---|---|
| QuestionnaireThis is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. A subsequent translation in different Language will provided based on geographical distribution. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous. The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice. | Other | – |
Primary outcome
Change in Burnout before COVID-19 and during COVID-19
Time frame: 1 year before COVID-19 versus during the COVID-19 pandemic (Mrach-June 2020)
A questionnaire designed based on the literature review to assess Burnout
Change in Job satisfaction before COVID-19 and during COVID-19
Time frame: 1 year before COVID-19 versus during the COVID-19 pandemic (Mrach-June 2020)
A questionnaire designed based on the literature review to assess Job satisfaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 38273390Shalaby M, ElSheikh AM, Hamed H; SURG-SAT-19 Collaborative Group. Burnout among surgeons before and during the SARS-CoV-2 pandemic: an international survey. BMC Psychol. 2024 Jan 25;12(1):48. doi: 10.1186/s40359-023-01517-4.
- 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.
Mostafa Shalaby, MD, MSc, PhD principal investigator
Mansoura Faculty of Medicine
Hosam Hamed, MD, MSc, PhD study chair
Mansoura Faculty of Medicine
Ahmed M Elsheikh, MD,MBA,CMQOE study director
Security Forces Program Hospital
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 Physical Stress and Career Burnout, run by Mansoura University at 1 site in Egypt.
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 16 Jun 2020. 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 Egypt. 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 Mostafa Shalaby, MD, MSc, PhD (00201001645917, mostafashalaby@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Burnout before COVID-19 and during COVID-19 (time frame: 1 year before COVID-19 versus during the COVID-19 pandemic (Mrach-June 2020)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04433286, which also lists 1 linked publication.
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 16 Jun 2020.