Surgery Clinical Trial
— SEE MIGSOfficial title:
Instituting Surgical Ergonomics Education Into the Curriculum of Obstetrics and Gynecology Residents During Minimally Invasive Gynecologic Skills Training: A Pilot Study
The goal of this pilot study is to learn if a class and hands-on-practice of ergonomic body positions - or specific ways to move the body while working to prevent injury - is valuable to training obstetrics and gynecology doctors. The main questions the study team aims to answer are: - Will these lessons successfully teach the participants how to move bodies at work in a way that will prevent injury? - Will the participants feel that learning and practicing such lessons helps to avoid injury while at work? Researchers will compare training obstetrics and gynecology doctors that attend a class on ergonomics and have guided hands-on-practice of ergonomic body positions with training obstetrics and gynecology doctors that attend the class only to see if the first group learns and remembers how to move their bodies safely while working. All participants will attend a class that teaches basic ergonomic lessons before they are divided into two groups. Group 1 will practice common surgery skills on a model while being videotaped by an artificial intelligence application. The application will make a report on unsafe positions a participant does while practicing surgical skills. The Group 1 participant will then go over the report with one of the study supervisors to talk about ways that the participant can move safely while practicing the skills. The participant will then practice the skills one more time while being videotaped. The study supervisors will then compare the two reports to see if the participant improved. Group 2 will also practice common surgery skills on a model while being videotaped. Group 2 participants will not get to see the report that the application generates or speak with the study supervisors about ways to move safely while practicing the skills. There will be a follow up after two months to see if participants remembered what was learned during the class and during the hands-on practice lesson. All participants will again be videotaped. The study supervisors will compare the videos and reports from the last class to the most recent ones to see if the participants learned and remember how to move safely while working. Participants in both groups will take a quiz about the lessons learned in the class before and after the class to determine what had been learned from the lesson. A survey about how useful and helpful the class was and hands-on practice sessions were will also be completed.
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Residents in Montefiore's OB/GYN residency program in post-graduate years 1 through 4 (PGY-1 - PGY-4) Exclusion Criteria: - Non-OB/GYN residents - Fellows in OB/GYN subspecialties - Medical students |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants that would recommend incorporating surgical ergonomics lecture/module as a permanent part of the didactic curriculum. | Acceptability will be assessed using the responses to the post-intervention survey question asking participants to select yes or no regarding whether they would recommend incorporating a lecture/module on surgical ergonomics into residency surgical curriculum. The number of participants selecting "yes" to this question will be tabulated with the number of participants selecting "yes" associated with higher acceptability. The number of participants selecting "no" to this question will be tabulated with a higher number of participants selecting "no" associated with a lower acceptability. | Through study completion, approximately 8 weeks | |
Primary | Number of participants that would recommend incorporating surgical ergonomics hands-on skills session with feedback and guided practice on surgical ergonomics as a permanent part of the didactic curriculum. | Acceptability will be assessed using the responses to the post-intervention survey question asking participants to select yes or no regarding whether they would recommend incorporating the hands-on skills session with feedback and guided practice on surgical ergonomics into residency surgical curriculum. The number of participants selecting "yes" to this question will be tabulated with the number of participants selecting "yes" associated with higher acceptability. The number of participants selecting "no" to this question will be tabulated with a higher number of participants selecting "no" associated with a lower acceptability. | Through study completion, approximately 8 weeks | |
Primary | Change from baseline in surgical ergonomic knowledge score over two sessions | Knowledge will be analyzed using the responses from pre- and post-test quizzes. The scores from the pre-test will be used as baseline. A higher score corresponds to a greater knowledge of surgical ergonomic principles. An increase in the post-test session 1 quiz score is associated with an increase in knowledge and corresponds to a positive gain in knowledge post-intervention. The same or decreased score on the post-test session 1 quiz is associated with no change in ergonomics knowledge and corresponds to a negative gain in knowledge following intervention. An increased or same score on the post-test session 2 quiz score corresponds to positive retention in surgical ergonomics knowledge. A decreased score on the post-test session 2 quiz score is associated with loss in knowledge and corresponds to no retention knowledge following intervention. | From enrollment during session 1 until conclusion of the study in session two - approximately 8 weeks | |
Primary | Change from baseline in surgical ergonomic practice based on rapid upper limb assessment (RULA) score over two sessions | Ergonomic practice following intervention will be analyzed using a change in cumulative RULA score over the course of two sessions. Scores of 3-7 are considered at risk for injury in this study. Baseline scores are obtained prior to intervention. After intervention, participants will be scored during session 1 and again during session 2 two months later. A decrease in score from pre-intervention to post-intervention session 1 corresponds to positive gain in ergonomic skill. The same/increased score for post-session 1 is associated with no change in practice and corresponds to a negative gain in skill. A decrease in score post-session 2, obtaining the same score as in post-session 1, or obtaining a score of 1-2 on post-intervention session 2 corresponds to positive retention in skill. An increase in score for post-session 2 is associated with loss in skill and corresponds to no retention in skill. | Baseline prior to intervention, from enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total | |
Primary | Change from baseline in surgical ergonomic practice based on rapid entire body assessment (REBA) score over two sessions | Ergonomic practice following intervention will be analyzed using a change in cumulative REBA score over the course of two sessions. Scores of 2-11 are considered at risk for injury in this study. Baseline scores are obtained prior to intervention. After intervention, participants will be scored during session 1 and again during session 2 two months later. A decrease in score from pre-intervention to post-intervention session 1 corresponds to positive gain in ergonomic skill. The same/increased score for post-session 1 is associated with no change in practice and corresponds to a negative gain in skill. A decrease in score post-session 2, obtaining the same score as in post-session 1, or obtaining a score of 1 on post-intervention session 2 corresponds to positive retention in skill. An increase in score for post-session 2 is associated with loss in skill and corresponds to no retention in skill. | Baseline prior to intervention, from enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total | |
Primary | Change from baseline in surgical ergonomic practice based on revised hand strain index (RHSI) score over two sessions | Ergonomic practice following intervention will be analyzed using a change in cumulative RHSI score over the course of two sessions. Scores of >10 are considered at risk for injury in this study. Baseline scores are obtained prior to intervention. After intervention, participants will be scored during session 1 and again during session 2 two months later. A decrease in score from pre-intervention to post-intervention session 1 corresponds to positive gain in ergonomic skill. The same/increased score for post-session 1 is associated with no change in practice and corresponds to a negative gain in skill. A decrease in score post-session 2, obtaining the same score as in post-session 1, or obtaining a score of 10 or less on post-intervention session 2 corresponds to positive retention in skill. An increase in score for post-session 2 is associated with loss in skill and corresponds to no retention in skill. | Baseline prior to intervention, from enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total | |
Secondary | Number of participants that reported an increase in knowledge following surgical ergonomics lecture/module and/or skills practice. | Increase in awareness of surgical ergonomic principles will be assessed using the responses on participant self-reported knowledge of surgical ergonomic principles on post-intervention survey. Responses are graded on a 5-point Likert scale. A higher score corresponds to greater self-reported knowledge of surgical ergonomic principles. The number of participants selecting "(4) agree" or "(5) strongly agree" to this question will be tabulated with scores of 16 or higher associated with an increased awareness of surgical ergonomics following intervention. | From enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total | |
Secondary | Number of participants that reported an increase in practice following surgical ergonomics lecture/module and/or skills practice. | Increase in awareness of surgical ergonomic practice will be assessed using the responses on participant self-reported change in ergonomic practice following intervention on post-intervention survey. Responses are graded on a 5-point Likert scale. A higher score corresponds to greater self-reported change in practice of surgical ergonomic principles. The number of participants selecting "(4) agree" or "(5) strongly agree" to this question will be tabulated with scores of 8 or higher associated with an increased awareness of surgical ergonomics. | From enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total | |
Secondary | Number of participants that reported that surgical ergonomics education is valuable following surgical ergonomics lecture/module and/or skills practice | Value of surgical ergonomic instruction after intervention will be assessed using the responses to the post-intervention survey question asking participants to select yes or no regarding whether they feel that learning surgical ergonomic principles during residency would be valuable. The number of participants selecting "yes" to this question will be tabulated with the number of participants selecting "yes" associated with higher valuation of surgical ergonomic instruction. The number of participants selecting "no" to this question will be tabulated with a higher number of participants selecting "no" associated with a lower valuation of surgical ergonomic instruction. | From enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total | |
Secondary | Number of participants with a change in pain scores following surgical ergonomics lecture/module and skills practice | Discomfort will be analyzed by comparing changes in cumulative pain/discomfort scores obtained from pre- and post-study modified Cornell Musculoskeletal Discomfort Questionnaire for standing work. Responses are graded on a 0-4 scale. A higher score corresponds to greater self-reported discomfort. A decrease in cumulative discomfort score from the first to the second corresponds to a decreased in self-reported discomfort post-intervention. An increase in cumulative discomfort score from the first to the second corresponds to an increased in self-reported discomfort post-intervention. The number of participants with a decrease in cumulative score following the intervention will be assessed as for possible secondary impact of long-term retention of surgical ergonomics instruction. | From enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total |
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