<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/NCT04492085</url>
  </required_header>
  <id_info>
    <org_study_id>CMDA-SURVEY1</org_study_id>
    <nct_id>NCT04492085</nct_id>
  </id_info>
  <brief_title>National Survey of Workplace Violence</brief_title>
  <acronym>CMDA-SURVEY1</acronym>
  <official_title>National Survey of Workplace Violence Against Chinese Physicians of Obstetrics and Gynecology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lei Li</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      China has witnessed a surge in violence against medical personnel, including widely reported&#xD;
      incidents of violent abuse, riots, attacks, and protests in hospitals, but little is known&#xD;
      about the definite prevalence of workplace violence against physicians of obstetrics and&#xD;
      gynecology in China. The aim of this study is to analyze prevalence of workplace violence&#xD;
      against physicians of obstetrics and gynecology in China. A customized questionnaire will be&#xD;
      delivered by the social software WeChat to the specific hospital which has been randomly&#xD;
      sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the&#xD;
      questionnaire anonymously.&#xD;
&#xD;
      A random sampling will be performed in all 32 provinces, municipality or autonomous regions&#xD;
      in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and&#xD;
      the sample size under the condition of simple random sampling is 600 persons. If the&#xD;
      homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting&#xD;
      survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3,&#xD;
      the sample size of every level needs is 1800. Considering 10% population refusing to be&#xD;
      surveyed, in all mainland of China, three levels of hospitals will include at least 6000&#xD;
      physicians who accept survey.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">September 27, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 27, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of workplace violence in all physicians</measure>
    <time_frame>In past 12 months</time_frame>
    <description>Percentage of verbal abuse, physical assault and sexual assaults</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Potential reasons of workplace violence in all physicians</measure>
    <time_frame>Two months</time_frame>
    <description>Percentage of different choices of potential reasons in a customized questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential solution of workplace violence in all physicians</measure>
    <time_frame>Two months</time_frame>
    <description>Percentage of different choices of potential solution in a customized questionnaire</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">6000</enrollment>
  <condition>Workplace Violence Against Physicians</condition>
  <condition>National Survey</condition>
  <condition>Obstetrics and Gynecology</condition>
  <condition>China</condition>
  <condition>Random Sample</condition>
  <condition>Questionnaire</condition>
  <arm_group>
    <arm_group_label>Primary hospital or clinics</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Secondary hospital</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Tertiary hospital</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire survey</intervention_name>
    <description>A customized questionnaire will be delivered by the social software WeChat to explore the prevalence, potential reasons and solutions of workplace violence against physicians of obstetrics and gynecology in China</description>
    <arm_group_label>Primary hospital or clinics</arm_group_label>
    <arm_group_label>Secondary hospital</arm_group_label>
    <arm_group_label>Tertiary hospital</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All physicians of obstetrics and gynecology from the hospitals randomly samples&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years old&#xD;
&#xD;
          -  Belonging to and registered at specific hospital&#xD;
&#xD;
          -  Active employment in obstetrics, reproduction, or gynecology&#xD;
&#xD;
          -  Signed an approved informed consents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not meeting all the inclusion criteria&#xD;
&#xD;
          -  Not completing the whole questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Lei Li, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Li, M.D.</last_name>
    <phone>8613911988831</phone>
    <email>lileigh@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Lei Li</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lei Li, MD</last_name>
      <phone>8613911988831</phone>
      <email>lileigh@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04492085
org study id: CMDA-SURVEY1
nct id: NCT04492085
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
China has witnessed a surge in violence against medical personnel, including widely reported
      incidents of violent abuse, riots, attacks, and protests in hospitals, but little is known
      about the definite prevalence of workplace violence against physicians of obstetrics and
      gynecology in China. The aim of this study is to analyze prevalence of workplace violence
      against physicians of obstetrics and gynecology in China. A customized questionnaire will be
      delivered by the social software WeChat to the specific hospital which has been randomly
      sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the
      questionnaire anonymously.

      A random sampling will be performed in all 32 provinces, municipality or autonomous regions
      in the mainland of China. It is assumed that acceptable 95% confidence interval is P±4%, and
      the sample size under the condition of simple random sampling is 600 persons. If the
      homogeneity is set as 0.15 or 0.2, and each population (unit) has 10 or 15 persons accepting
      survey, we will achieve a design effect of 2.35 to 3.80. If we choose the design effect of 3,
      the sample size of every level needs is 1800. Considering 10% population refusing to be
      surveyed, in all mainland of China, three levels of hospitals will include at least 6000
      physicians who accept survey.
observational model: Cohort
time perspective: Prospective
measure: Prevalence of workplace violence in all physicians
time frame: In past 12 months
description: Percentage of verbal abuse, physical assault and sexual assaults
measure: Potential reasons of workplace violence in all physicians
time frame: Two months
description: Percentage of different choices of potential reasons in a customized questionnaire
measure: Potential solution of workplace violence in all physicians
time frame: Two months
description: Percentage of different choices of potential solution in a customized questionnaire
arm group label: Primary hospital or clinics
arm group label: Secondary hospital
arm group label: Tertiary hospital
intervention type: Other
intervention name: Questionnaire survey
description: A customized questionnaire will be delivered by the social software WeChat to explore the prevalence, potential reasons and solutions of workplace violence against physicians of obstetrics and gynecology in China
arm group label: Primary hospital or clinics
arm group label: Secondary hospital
arm group label: Tertiary hospital
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Lei Li, M.D.
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
last name: Lei Li, M.D.
phone: 8613911988831
email: lileigh@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: Professor
sharing ipd: Undecided