- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03623009
Gender Stigma Consciousness and Surgical Training
October 2, 2019 updated by: Sara Myers, University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15218
- UPMC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
An article meant to trigger certain psychosocial behaviors is administered to the intervention arm prior to laparoscopic skills assessment.
|
An article meant to trigger certain psychosocial behaviors is administered to the intervention arm prior to laparoscopic skills assessment.
|
Sham Comparator: Control
The control arm will receive a neutral article prior to completing the assessment.
|
The control arm will receive a neutral article prior to completing the assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score on laparoscopic skills assessment
Time Frame: 12 months
|
Score (continuous outcome) based on verified fundamentals of laparoscopic skills assessment grading rubric.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in psychosocial constructs
Time Frame: 12 months
|
Changes in Likert scale ratings of psychosocial constructs as assessed by survey with previously published verified sub scales.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sara P Myers, MD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 1, 2019
Study Registration Dates
First Submitted
August 6, 2018
First Submitted That Met QC Criteria
August 8, 2018
First Posted (Actual)
August 9, 2018
Study Record Updates
Last Update Posted (Actual)
October 3, 2019
Last Update Submitted That Met QC Criteria
October 2, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- PRO18040386
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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