<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04433286</url>
  </required_header>
  <id_info>
    <org_study_id>SURG RES COL 1</org_study_id>
    <nct_id>NCT04433286</nct_id>
  </id_info>
  <brief_title>COVID-19 - Implications on Surgeons' Burnout and Career Satisfaction</brief_title>
  <acronym>SURG-SAT-19</acronym>
  <official_title>COVID-19 - Implications on Surgeons' Burnout and Career Satisfaction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a cross-sectional survey which will be distributed online between surgeons. The&#xD;
      survey was proposed by a consensus of consultants of surgery and revised by an improvement&#xD;
      consultant. It consists of a semi-structured questionnaire that is provided in English&#xD;
      language. The survey will be conducted online through an online survey development&#xD;
      cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the&#xD;
      nature of the survey and informed that they will be listed as co-authors. Collected data will&#xD;
      be confidential and anonymous.&#xD;
&#xD;
      The first sector of the questionnaire includes trainee demographics and baseline&#xD;
      characteristics. Then the questionnaire aims to compare the trainee experience before and&#xD;
      after the pandemic with focus on research activities, clinical, and surgical practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional survey which will be distributed online between surgeons. The&#xD;
      survey was proposed by a consensus of consultants of surgery and revised by an improvement&#xD;
      consultant. It consists of a semi-structured questionnaire that is provided in English&#xD;
      language. A subsequent translation in different Language will provided based on geographical&#xD;
      distribution. The survey will be conducted online through an online survey development&#xD;
      cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the&#xD;
      nature of the survey and informed that they will be listed as co-authors. Collected data will&#xD;
      be confidential and anonymous.&#xD;
&#xD;
      The first sector of the questionnaire includes trainee demographics and baseline&#xD;
      characteristics. Then the questionnaire aims to compare the trainee experience before and&#xD;
      after the pandemic with focus on research activities, clinical, and surgical practice.&#xD;
&#xD;
      Statistical analyses will be performed using SPSS v. 20. Data distribution will be tested for&#xD;
      normality using the Kolmogorov-Smirnov test and the Shapiro-Wilk test. Categorical variables&#xD;
      will be expressed as group percentages and will be compared for independent samples using the&#xD;
      Chi-square test. Continuous data of the survey will be presented as medians with ranges or&#xD;
      means and standard deviations. A comparison of continuous data will be compared for&#xD;
      independent samples using the T-test or Mann-Whitney test according to the data distribution.&#xD;
      Spearman correlation coefficient will be used for further assessment of the strength of the&#xD;
      association between variables. The statistical significance level will be set at &lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 15, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Burnout before COVID-19 and during COVID-19</measure>
    <time_frame>1 year before COVID-19 versus during the COVID-19 pandemic (Mrach-June 2020)</time_frame>
    <description>A questionnaire designed based on the literature review to assess Burnout</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Job satisfaction before COVID-19 and during COVID-19</measure>
    <time_frame>1 year before COVID-19 versus during the COVID-19 pandemic (Mrach-June 2020)</time_frame>
    <description>A questionnaire designed based on the literature review to assess Job satisfaction</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Physical Stress</condition>
  <condition>Career Burnout</condition>
  <condition>Satisfaction</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <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.&#xD;
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.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Surgeons of all specialities; Cardiothoracic, General, Neurosurgery, Oral and&#xD;
        Maxillofacial, Otolaryngology, Pediatric, Plastic, Trauma and Orthopedic, Urology, and&#xD;
        Vascular Surgery. Furthermore, Gynecological Oncology and Urogynecology surgeons are&#xD;
        invited.&#xD;
&#xD;
        Both sex.&#xD;
&#xD;
        All over the globe.&#xD;
&#xD;
        Any level of experiences.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The Survey is targeting surgeons of all specialities; Cardiothoracic, General,&#xD;
             Neurosurgery, Oral and Maxillofacial, Otolaryngology, Pediatric, Plastic, Trauma and&#xD;
             Orthopedic, Urology, and Vascular Surgery. Furthermore, Gynecological Oncology and&#xD;
             Urogynecology surgeons are invited.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other specialities other than surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mostafa Shalaby, MD, MSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hosam Hamed, MD, MSc, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura Faculty of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed M Elsheikh, MD,MBA,CMQOE</last_name>
    <role>Study Director</role>
    <affiliation>Security Forces Program Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mostafa Shalaby, MD, MSc, PhD</last_name>
    <phone>00201001645917</phone>
    <email>mostafashalaby@mans.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hosam Hamed, MD, MSc, PhD</last_name>
    <phone>00201006178599</phone>
    <email>hosam-eldin@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Faculty of Medicine Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Mostafa shalaby, MD, MSc, PhD</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Professional</mesh_term>
    <mesh_term>Burnout, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433286
org study id: SURG RES COL 1
nct id: NCT04433286
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Cross-Sectional
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)
description: A questionnaire designed based on the literature review to assess Burnout
measure: 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)
description: A questionnaire designed based on the literature review to assess Job satisfaction
intervention type: Other
intervention name: Questionnaire
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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mostafa Shalaby, MD, MSc, PhD
role: Principal Investigator
affiliation: Mansoura Faculty of Medicine
last name: Hosam Hamed, MD, MSc, PhD
role: Study Chair
affiliation: Mansoura Faculty of Medicine
last name: Ahmed M Elsheikh, MD,MBA,CMQOE
role: Study Director
affiliation: Security Forces Program Hospital
last name: Mostafa Shalaby, MD, MSc, PhD
phone: 00201001645917
email: mostafashalaby@mans.edu.eg
last name: Hosam Hamed, MD, MSc, PhD
phone: 00201006178599
email: hosam-eldin@hotmail.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Mostafa shalaby, MD, MSc, PhD
investigator title: Dr
mesh term: Burnout, Professional
mesh term: Burnout, Psychological
sharing ipd: No