Gender IssuesNCT03623009
Gender Stigma Consciousness and Surgical Training
A study testing An article meant to trigger certain psychosocial behaviors and a neutral article in people with Gender Issues, run by University of Pittsburgh at 1 site in United States.
Trial summary
Previous investigations have focused on challenges that surgeons face once they have entered into practice. We have yet to explore difficulties in the training environment, and whether these have an effect on professional development. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gender Issues
- What is being tested?
- An article meant to trigger certain psychosocial behaviors and a neutral article
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 1 Aug 2019
- Phase
- Interventional
- 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
Inclusion Criteria: Categorical General surgery residents who completed undergraduate medical education in the United States
Exclusion Criteria: Residents who have completed graduate medical education training in a subspecialty prior to their general surgery residency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Gender-stigma Consciousness on General Surgery Trainees' Experiences and Skill Performance.
Previous investigations have focused on challenges that surgeons face once they have entered into practice. We have yet to explore difficulties in the training environment, and whether these have an effect on professional development. In this study, we investigate how certain environmental factors can affect skill acquisition for the resident surgeon. Our trial tests whether psychosocial constructs affect task-performance. This study is a multi-center endeavor with the University of North Carolina-Chapel Hill, the University of Washington, and UPMC. Over an 12 month period, residents will be asked to complete surveys and a laparoscopic skills assessment, which will be administered after residents are randomized to an intervention or control arm. The intervention arm will be asked to read an article that is meant to trigger psychosocial constructs that we hypothesize will affect skill performance. The control arm will receive a neutral article prior to completing the laparoscopic skills assessment.
- Conditions
- Gender Issues
- Being tested
- An article meant to trigger certain psychosocial behaviors, a neutral article
- Medical subject headings
- Sexism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An article meant to trigger certain psychosocial behaviorsBehavioural
An article meant to trigger certain psychosocial behaviors is administered to the intervention arm prior to laparoscopic skills assessment.
a neutral articleBehavioural
The control arm will receive a neutral article prior to completing the assessment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | An article meant to trigger certain psychosocial behaviors is administered to the intervention arm prior to laparoscopic skills assessment. Receives: Behavioral: An article meant to trigger certain psychosocial behaviors |
| Control | Sham comparator | The control arm will receive a neutral article prior to completing the assessment. Receives: Behavioral: a neutral article |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on laparoscopic skills assessment
Score (continuous outcome) based on verified fundamentals of laparoscopic skills assessment grading rubric.
Measured: 12 months
Secondary outcomes (1)
Changes in psychosocial constructs
Changes in Likert scale ratings of psychosocial constructs as assessed by survey with previously published verified sub scales.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
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 Gender IssuesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Myers, University of Pittsburgh
- Investigators
- Sara P Myers, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623009
- Sponsor's protocol ID
- PRO18040386
- Status last verified
- Oct 2019
- First submitted
- 6 Aug 2018
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Myers SP, Dasari M, Brown JB, Lumpkin ST, Neal MD, Abebe KZ, Chaumont N, Downs-Canner SM, Flanagan MR, Lee KK, Rosengart MR. Effects of Gender Bias and Stereotypes in Surgical Training: A Randomized Clinical Trial. JAMA Surg. 2020 Jul 1;155(7):552-560. doi: 10.1001/jamasurg.2020.1127.
PubMed 32432669
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gender-stigma Consciousness on General Surgery Trainees' Experiences and Skill Performance.
- ClinicalTrials.gov ID
- NCT03623009
- Acronym / sponsor ID
- PRO18040386
- Conditions
- Gender Issues
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Washington
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 9 Aug 2018 (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.
Previous investigations have focused on challenges that surgeons face once they have entered into practice. We have yet to explore difficulties in the training environment, and whether these have an effect on professional development. In this study, we investigate how certain environmental factors can affect skill acquisition for the resident surgeon. Our trial tests whether psychosocial constructs affect task-performance. This study is a multi-center endeavor with the University of North Carolina-Chapel Hill, the University of Washington, and UPMC. Over an 12 month period, residents will be asked to complete surveys and a laparoscopic skills assessment, which will be administered after residents are randomized to an intervention or control arm. The intervention arm will be asked to read an article that is meant to trigger psychosocial constructs that we hypothesize will affect skill performance. The control arm will receive a neutral article prior to completing the laparoscopic skills assessment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: An article meant to trigger certain psychosocial behaviorsAn article meant to trigger certain psychosocial behaviors is administered to the intervention arm prior to laparoscopic skills assessment. |
| Control | Sham comparator | Behavioral: a neutral articleThe control arm will receive a neutral article prior to completing the assessment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| An article meant to trigger certain psychosocial behaviorsAn article meant to trigger certain psychosocial behaviors is administered to the intervention arm prior to laparoscopic skills assessment. | Behavioural | Intervention |
| a neutral articleThe control arm will receive a neutral article prior to completing the assessment. | Behavioural | Control |
Primary outcome
Score on laparoscopic skills assessment
Time frame: 12 months
Score (continuous outcome) based on verified fundamentals of laparoscopic skills assessment grading rubric.
1 secondary outcome
Changes in psychosocial constructs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Derived from this study: PubMed 32432669Myers SP, Dasari M, Brown JB, Lumpkin ST, Neal MD, Abebe KZ, Chaumont N, Downs-Canner SM, Flanagan MR, Lee KK, Rosengart MR. Effects of Gender Bias and Stereotypes in Surgical Training: A Randomized Clinical Trial. JAMA Surg. 2020 Jul 1;155(7):552-560. doi: 10.1001/jamasurg.2020.1127.
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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.
Sara P Myers, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An article meant to trigger certain psychosocial behaviors and a neutral article in people with Gender Issues, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on laparoscopic skills assessment (time frame: 12 months). 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 NCT03623009, 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 3 Oct 2019.