- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07609420
Surgical Ergonomics in OBGYN
May 19, 2026 updated by: Ayesha Kar Kasal, University Hospitals Cleveland Medical Center
Surgical Ergonomics in OBGYN Trainees & Attendings
This is a voluntary research study to implement and assess the efficacy of interventions aimed to improve surgical ergonomics in OBGYN residents, fellows, and attendings and decrease the incidence of work-related musculoskeletal disorders (WRMD).
We want to learn the baseline incidence of WMRD in our population and to see if the implementation of a surgical ergonomics lecture, pre-operative surgical ergonomics time-out, and intra-operative stretch breaks will improve the incidence of WRMD in this population.
Study Overview
Status
Not yet recruiting
Study Type
Interventional
Enrollment (Estimated)
50
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 Contact
- Name: Ayesha Kar, MD
- Phone Number: 2168441000
- Email: ayesha.karkasal@uhhospitals.org
Study Locations
-
-
Ohio
-
Beachwood, Ohio, United States, 44122
- University Hospitals Ahuja Medical Center
-
Contact:
- Ayesha Kar, MD
- Phone Number: 2168441000
- Email: ayesha.karkasal@uhhospitals.org
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
-
Contact:
- Ayesha Kar, MD
- Phone Number: 2168441000
- Email: ayesha.karkasal@uhhospitals.org
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Current attending in the OBGYN department at University Hospitals Current resident or fellow in the OBGYN department at University Hospitals Participation in laparoscopic or open surgical procedures
Exclusion Criteria:
Not a current fellow, resident, or attending in the OBGYN department at University Hospitals
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
Intervention 1: Surgical Ergonomics Lecture Intervention 2: 6 months of pre-surgical time out procedure focusing on surgical ergonomics Intervention 3: 6 months of intra-operative stretch breaks
|
60 min lecture regarding surgical ergonomics
Pre-incision time-out (30-60s) focusing on surgical ergonomics in OR prior to starting a surgery
30-60s breaks every 90 min to perform stretches during a surgical procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom frequency as measured by the Cornell Muscular Discomfort (MSK) Questionnaire
Time Frame: weekly x 12 months
|
Symptom frequency is measured on a likert scale of 0-4, with 0 being never and 4 being several times a day.
|
weekly x 12 months
|
|
Symptom severity as measured by the Cornell Muscular Discomfort (MSK) Questionnaire
Time Frame: weekly x 12 months
|
Symptom severity is measured on a scale of 0-3, with 0 being slightly uncomfortable and 3 being very uncomfortable.
|
weekly x 12 months
|
|
Work interference as measured by the Cornell Muscular Discomfort (MSK) Questionnaire
Time Frame: weekly x 12 months
|
Work interference is measured on a scale of 0-3, with 0 being not at all and 3 being substantially interfered.
|
weekly x 12 months
|
|
Total Cornell Muscular Discomfort Scores
Time Frame: Weekly x 12 months
|
For each body region, a region-specific Cornell MSK discomfort score will be calculated as: Frequency × Severity × Work Interference.
This yields a possible score range of 0-36 per body region.
|
Weekly x 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of work related musculoskeletal disorders (WRMDs)
Time Frame: 1 month
|
Initial incidence (presence or absence) of work related MSK disorders
|
1 month
|
|
Number of days of painkiller use
Time Frame: weekly x 12 months
|
Measure of how many days per week a participant took over the counter medications (such as NSAIDs or tylenol) for musculoskeletal pain related to work.
Scoring includes 0 days, 1-3 days, 4-5 days, daily
|
weekly x 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ayesha Kar Kasal, University Hospitals Cleveland Medical Center
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.
General Publications
- 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.
- Tsunemi M, Matsuzaki I, Hori Y, Hayashi K, Tamada H, Yamada S, Matsuzaki K, Sakai K, Kamijima M, Ebara T. The One-Minute Triple Stretch Reduces Musculoskeletal Discomfort in Endoscopic Assistants: A Crossover Trial With Motion Analysis. Dig Endosc. 2026 Jan;38(1):e70040. doi: 10.1111/den.70040. Epub 2025 Oct 13.
- Restaino S, D'Indinosante M, Perelli F, Arcieri M, Cherchi V, Petrillo M, Cavaliere AF, Cianci S, Pellecchia G, Meniconi RL, Coppola A, Chiantera V, Scambia G, Driul L, Vizzielli G; SPIGC Working Group. Ergonomics in the operating room and surgical training: a survey on the Italian scenario. Front Public Health. 2024 Aug 7;12:1417250. doi: 10.3389/fpubh.2024.1417250. eCollection 2024.
- Young RJ, Allen A, McIntire D, Robinson EF, Bougie O, Kho KA. Work Related Pain in Gynecologic Surgeons - A National Survey. J Minim Invasive Gynecol. 2025 Jul;32(7):614-620.e3. doi: 10.1016/j.jmig.2025.01.014. Epub 2025 Feb 1.
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 (Estimated)
August 12, 2026
Primary Completion (Estimated)
July 16, 2027
Study Completion (Estimated)
July 16, 2027
Study Registration Dates
First Submitted
May 19, 2026
First Submitted That Met QC Criteria
May 19, 2026
First Posted (Actual)
May 27, 2026
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 19, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- STUDY20251677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Institution specific study
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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