NCT06386601

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

6 months

First QC Date

April 18, 2024

Last Update Submit

September 4, 2025

Conditions

Keywords

surgical ergonomics educationobstetrics and gynecologyminimally invasive gynecologic surgeryresidents

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Number of participants that reported an increase in knowledge following surgical ergonomics lecture/module and/or skills practice.

    From enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total

  • Number of participants that reported an increase in practice following surgical ergonomics lecture/module and/or skills practice.

    From enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total

  • Number of participants that reported that surgical ergonomics education is valuable following surgical ergonomics lecture/module and/or skills practice

    From enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total

  • Number of participants with a change in pain scores following surgical ergonomics lecture/module and skills practice

    From enrollment during session 1 until conclusion of study in session 2, approximately 8 weeks total

Study Arms (2)

Intervention group

EXPERIMENTAL

This group will receive directed feedback and guided practice regarding their ergonomic positioning while performing basic surgical skills exercises on a trainer

Other: Ergonomics KnowledgeOther: Ergonomics Feedback/Guided Practice

Control

OTHER

This group will not receive directed feedback or guided practice regarding their ergonomic positioning while performing basic surgical skills exercises on a trainer during the study. After the study is completed they will receive this feedback, but it will not be included as a part of the study data.

Other: Ergonomics Knowledge

Interventions

Participants will participate in a lecture/module on surgical ergonomics

ControlIntervention group

Participants will practice minimally invasive surgical skills while receiving feedback on ergonomic positioning/practice

Intervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Residents in Montefiore's OB/GYN residency program in post-graduate years 1 through 4 (PGY-1 - PGY-4)

You may not qualify if:

  • Non-OB/GYN residents
  • Fellows in OB/GYN subspecialties
  • Medical students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (20)

  • Seagull FJ. Disparities between industrial and surgical ergonomics. Work. 2012;41 Suppl 1:4669-72. doi: 10.3233/WOR-2012-0107-4669.

    PMID: 22317439BACKGROUND
  • Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135.

    PMID: 25524443BACKGROUND
  • Lee G, Berguer R. Surgical Ergonomics Recommendations. American College of Surgeons Division of Education and Surgical Ergonomics Committee. 2023: 1-16

    BACKGROUND
  • Adams SR, Hacker MR, McKinney JL, Elkadry EA, Rosenblatt PL. Musculoskeletal pain in gynecologic surgeons. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):656-60. doi: 10.1016/j.jmig.2013.04.013. Epub 2013 Jun 21.

    PMID: 23796512BACKGROUND
  • Franasiak J, Craven R, Mosaly P, Gehrig PA. Feasibility and acceptance of a robotic surgery ergonomic training program. JSLS. 2014 Oct-Dec;18(4):e2014.00166. doi: 10.4293/JSLS.2014.00166.

    PMID: 25489213BACKGROUND
  • Davis WT, Fletcher SA, Guillamondegui OD. Musculoskeletal occupational injury among surgeons: effects for patients, providers, and institutions. J Surg Res. 2014 Jun 15;189(2):207-212.e6. doi: 10.1016/j.jss.2014.03.013. Epub 2014 Mar 13.

    PMID: 24721601BACKGROUND
  • Wauben LS, van Veelen MA, Gossot D, Goossens RH. Application of ergonomic guidelines during minimally invasive surgery: a questionnaire survey of 284 surgeons. Surg Endosc. 2006 Aug;20(8):1268-74. doi: 10.1007/s00464-005-0647-y. Epub 2006 Jul 20.

    PMID: 16858528BACKGROUND
  • Smith TG, Lowndes BR, Schmida E, Lund SB, Linden AR, Rivera M, Gas BL, Hallbeck MS. Course Design and Learning Outcomes of a Practical Online Ergonomics Course for Surgical Residents. J Surg Educ. 2022 Nov-Dec;79(6):1489-1499. doi: 10.1016/j.jsurg.2022.07.005. Epub 2022 Jul 27.

    PMID: 35907697BACKGROUND
  • Epstein S, Tran BN, Capone AC, Ruan QZ, Fukudome EY, Ricci JA, Testa MA, Dennerlein JT, Lee BT, Singhal D. The Current State of Surgical Ergonomics Education in U.S. Surgical Training: A Survey Study. Ann Surg. 2019 Apr;269(4):778-784. doi: 10.1097/SLA.0000000000002592.

    PMID: 29381528BACKGROUND
  • Park AE, Zahiri HR, Hallbeck MS, Augenstein V, Sutton E, Yu D, Lowndes BR, Bingener J. Intraoperative "Micro Breaks" With Targeted Stretching Enhance Surgeon Physical Function and Mental Focus: A Multicenter Cohort Study. Ann Surg. 2017 Feb;265(2):340-346. doi: 10.1097/SLA.0000000000001665.

    PMID: 28059962BACKGROUND
  • Hallbeck MS, Lowndes BR, Bingener J, Abdelrahman AM, Yu D, Bartley A, Park AE. The impact of intraoperative microbreaks with exercises on surgeons: A multi-center cohort study. Appl Ergon. 2017 Apr;60:334-341. doi: 10.1016/j.apergo.2016.12.006. Epub 2016 Dec 29.

    PMID: 28166893BACKGROUND
  • Supe AN, Kulkarni GV, Supe PA. Ergonomics in laparoscopic surgery. J Minim Access Surg. 2010 Apr;6(2):31-6. doi: 10.4103/0972-9941.65161.

    PMID: 20814508BACKGROUND
  • Cerier E, Hu A, Goldring A, Rho M, Kulkarni SA. Ergonomics Workshop Improves Musculoskeletal Symptoms in General Surgery Residents. J Surg Res. 2022 Dec;280:567-574. doi: 10.1016/j.jss.2022.06.014. Epub 2022 Jul 2.

    PMID: 35787315BACKGROUND
  • Franasiak J, Ko EM, Kidd J, Secord AA, Bell M, Boggess JF, Gehrig PA. Physical strain and urgent need for ergonomic training among gynecologic oncologists who perform minimally invasive surgery. Gynecol Oncol. 2012 Sep;126(3):437-42. doi: 10.1016/j.ygyno.2012.05.016. Epub 2012 May 18.

    PMID: 22613351BACKGROUND
  • Stucky CH, Cromwell KD, Voss RK, Chiang YJ, Woodman K, Lee JE, Cormier JN. Surgeon symptoms, strain, and selections: Systematic review and meta-analysis of surgical ergonomics. Ann Med Surg (Lond). 2018 Jan 9;27:1-8. doi: 10.1016/j.amsu.2017.12.013. eCollection 2018 Mar.

    PMID: 29511535BACKGROUND
  • Hamilton BC, Dairywala MI, Highet A, Nguyen TC, O'Sullivan P, Chern H, Soriano IS. Artificial intelligence based real-time video ergonomic assessment and training improves resident ergonomics. Am J Surg. 2023 Nov;226(5):741-746. doi: 10.1016/j.amjsurg.2023.07.028. Epub 2023 Jul 20.

    PMID: 37500299BACKGROUND
  • Jensen MJ, Liao J, Van Gorp B, Sugg SL, Shelton J, Corwin C, Lal G. Incorporating Surgical Ergonomics Education into Surgical Residency Curriculum. J Surg Educ. 2021 Jul-Aug;78(4):1209-1215. doi: 10.1016/j.jsurg.2020.11.004. Epub 2020 Nov 19.

    PMID: 33221251BACKGROUND
  • Edwards C, Fortingo N, Franklin E. Ergonomics. 2024 Feb 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK580551/

    PMID: 35593858BACKGROUND
  • Yurteri-Kaplan LA, Park AJ. Surgical Ergonomics and Preventing Work-Related Musculoskeletal Disorders. Obstet Gynecol. 2023 Mar 1;141(3):455-462. doi: 10.1097/AOG.0000000000005079. Epub 2023 Feb 2. No abstract available.

    PMID: 36735407BACKGROUND
  • Lin E, Young R, Chao L, et al. Raising the bar (and the OR table): Ergonomics in MIGS . OBG Management. 2023: SS3-SS9. Doi 10.12788/obgm.0287

    BACKGROUND

Related Links

Study Officials

  • Kari Plewniak, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be stratified into junior residents (1st and 2nd year) and senior residents (3rd and 4th year) and then randomized to the intervention group or control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 26, 2024

Study Start

December 1, 2024

Primary Completion

May 22, 2025

Study Completion

May 22, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations