Workplace Violence Against PhysiciansCMDA-SURVEY1NCT04492085
National Survey of Workplace Violence
An observational study of Workplace Violence Against Physicians and National Survey, run by Lei Li at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Workplace Violence Against Physicians, National Survey, Obstetrics and Gynecology
- What is being tested?
- Questionnaire survey
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2020to 27 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All physicians of obstetrics and gynecology from the hospitals randomly samples
Who may be able to join
- Aged 18 years old
- Belonging to and registered at specific hospital
- Active employment in obstetrics, reproduction, or gynecology
- Signed an approved informed consents
Who cannot join
- Not meeting all the inclusion criteria
- Not completing the whole questionnaire
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Lei Li
Beijing, Beijing Municipality, 100730
Lei Li, MD, 8613911988831, lileigh@163.com
About this study
Official title: National Survey of Workplace Violence Against Chinese Physicians of Obstetrics and Gynecology
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.
- Conditions
- Workplace Violence Against Physicians, National Survey, Obstetrics and Gynecology, China, Random Sample, Questionnaire
- Being tested
- Questionnaire survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire surveyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Primary hospital or clinics | Not described Receives: Other: Questionnaire survey | |
| Secondary hospital | Not described Receives: Other: Questionnaire survey | |
| Tertiary hospital | Not described Receives: Other: Questionnaire survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of workplace violence in all physicians
Percentage of verbal abuse, physical assault and sexual assaults
Measured: In past 12 months
Secondary outcomes (2)
Potential reasons of workplace violence in all physicians
Percentage of different choices of potential reasons in a customized questionnaire
Measured: Two months
Potential solution of workplace violence in all physicians
Percentage of different choices of potential solution in a customized questionnaire
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start27 Jul 2020
- Primary completion27 Sep 2020 (estimated)
- Study completion27 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Workplace Violence Against PhysiciansStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Li, Peking Union Medical College Hospital
- Investigators
- Lei Li, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492085
- Sponsor's protocol ID
- CMDA-SURVEY1
- Acronym
- CMDA-SURVEY1
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Survey of Workplace Violence Against Chinese Physicians of Obstetrics and Gynecology
- ClinicalTrials.gov ID
- NCT04492085
- Acronym / sponsor ID
- CMDA-SURVEY1 / CMDA-SURVEY1
- Conditions
- Workplace Violence Against Physicians, National Survey, Obstetrics and Gynecology, China, Random Sample, Questionnaire
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Lei LiUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 27 Sep 2020 (estimated)
- Study completion
- 27 Sep 2020 (estimated)
- First posted
- 30 Jul 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary hospital or clinics | – | Other: Questionnaire survey |
| Secondary hospital | – | Other: Questionnaire survey |
| Tertiary hospital | – | Other: Questionnaire survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All physicians of obstetrics and gynecology from the hospitals randomly samples
Key inclusion criteria (4 listed)
- Aged 18 years old
- Belonging to and registered at specific hospital
- Active employment in obstetrics, reproduction, or gynecology
- Signed an approved informed consents
Key exclusion criteria (2 listed)
- Not meeting all the inclusion criteria
- Not completing the whole questionnaire
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 |
|---|---|---|
| Questionnaire surveyA 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 | Other | Primary hospital or clinics, Secondary hospital, Tertiary hospital |
Primary outcome
Prevalence of workplace violence in all physicians
Time frame: In past 12 months
Percentage of verbal abuse, physical assault and sexual assaults
2 secondary outcomes
Potential reasons of workplace violence in all physicians
Time frame: Two months
Potential solution of workplace violence in all physicians
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Lei Li, M.D. principal investigator
Peking Union Medical College 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 Workplace Violence Against Physicians and National Survey, run by Lei Li at 1 site in China.
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 4 inclusion and 2 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 30 Jul 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 China. 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 Lei Li, M.D. (8613911988831, lileigh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of workplace violence in all physicians (time frame: In past 12 months). 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 30 Jul 2020.