Current OBGYN Attending, Resident, or Fellow at University HospitalsNCT07609420
Surgical Ergonomics in OBGYN
A study testing Surgical Ergonomics Lecture, Pre-Incision Surgical Ergonomics Time Out and Intra-operative stretch breaks in people with Current OBGYN Attending, Resident, or Fellow at University Hospitals, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Current OBGYN Attending, Resident, or Fellow at University Hospitals
- What is being tested?
- Surgical Ergonomics Lecture, Pre-Incision Surgical Ergonomics Time Out and Intra-operative stretch breaks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Aug 2026to 16 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not a current fellow, resident, or attending in the OBGYN department at University Hospitals
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University Hospitals Ahuja Medical Center
Beachwood, Ohio, 44122
Ayesha Kar, MD, 2168441000, ayesha.karkasal@uhhospitals.org
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ayesha Kar, MD, 2168441000, ayesha.karkasal@uhhospitals.org
About this study
Official title: 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.
- Being tested
- Surgical Ergonomics Lecture, Pre-Incision Surgical Ergonomics Time Out, Intra-operative stretch breaks
- Keywords
- surgical ergonomics, obstetrics & gynecology, medical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Ergonomics LectureBehavioural
60 min lecture regarding surgical ergonomics
Pre-Incision Surgical Ergonomics Time OutBehavioural
Pre-incision time-out (30-60s) focusing on surgical ergonomics in OR prior to starting a surgery
Intra-operative stretch breaksBehavioural
30-60s breaks every 90 min to perform stretches during a surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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 Receives: Behavioral: Surgical Ergonomics Lecture; Behavioral: Pre-Incision Surgical Ergonomics Time Out; Behavioral: Intra-operative stretch breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom frequency as measured by the Cornell Muscular Discomfort (MSK) Questionnaire
Symptom frequency is measured on a likert scale of 0-4, with 0 being never and 4 being several times a day.
Measured: weekly x 12 months
Symptom severity as measured by the Cornell Muscular Discomfort (MSK) Questionnaire
Symptom severity is measured on a scale of 0-3, with 0 being slightly uncomfortable and 3 being very uncomfortable.
Measured: weekly x 12 months
Work interference as measured by the Cornell Muscular Discomfort (MSK) Questionnaire
Work interference is measured on a scale of 0-3, with 0 being not at all and 3 being substantially interfered.
Measured: weekly x 12 months
Total Cornell Muscular Discomfort Scores
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.
Measured: Weekly x 12 months
Secondary outcomes (2)
Incidence of work related musculoskeletal disorders (WRMDs)
Initial incidence (presence or absence) of work related MSK disorders
Measured: 1 month
Number of days of painkiller use
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
Measured: weekly x 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start12 Aug 2026
- Primary completion16 Jul 2027 (estimated)
- Study completion16 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Current OBGYN Attending, Resident, or Fellow at University HospitalsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Kar Kasal, University Hospitals Cleveland Medical Center
- Investigators
- Ayesha Kar Kasal, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609420
- Sponsor's protocol ID
- STUDY20251677
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Institution specific study
Publications
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.
PubMed 41077957Park 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.
PubMed 28059962Restaino 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.
PubMed 39171296Young 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.
PubMed 39900174
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Ergonomics in OBGYN Trainees & Attendings
- ClinicalTrials.gov ID
- NCT07609420
- Acronym / sponsor ID
- STUDY20251677
- Keywords
- surgical ergonomics, obstetrics & gynecology, medical education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 12 Aug 2026 (actual)
- Primary completion
- 16 Jul 2027 (estimated)
- Study completion
- 16 Jul 2027 (estimated)
- First posted
- 27 May 2026 (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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Surgical Ergonomics Lecture, Behavioral: Pre-Incision Surgical Ergonomics Time Out, Behavioral: Intra-operative stretch breaksIntervention 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Not a current fellow, resident, or attending in the OBGYN department at University Hospitals
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 |
|---|---|---|
| Surgical Ergonomics Lecture60 min lecture regarding surgical ergonomics | Behavioural | Intervention Arm |
| Pre-Incision Surgical Ergonomics Time OutPre-incision time-out (30-60s) focusing on surgical ergonomics in OR prior to starting a surgery | Behavioural | Intervention Arm |
| Intra-operative stretch breaks30-60s breaks every 90 min to perform stretches during a surgical procedure | Behavioural | Intervention Arm |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Incidence of work related musculoskeletal disorders (WRMDs)
Time frame: 1 month
Number of days of painkiller use
Time frame: weekly x 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 41077957Tsunemi 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.
- Background: PubMed 28059962Park 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.
- Background: PubMed 39171296Restaino 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.
- Background: PubMed 39900174Young 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.
- American College of Surgeons: Surgical Ergonomics RecommendationsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Institution specific study
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.
Ayesha Kar Kasal principal investigator
University Hospitals Cleveland Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Ergonomics Lecture, Pre-Incision Surgical Ergonomics Time Out and Intra-operative stretch breaks in people with Current OBGYN Attending, Resident, or Fellow at University Hospitals, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayesha Kar, MD (2168441000, ayesha.karkasal@Uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom frequency as measured by the Cornell Muscular Discomfort (MSK) Questionnaire (time frame: weekly x 12 months). The study lists 4 primary outcomes in all. 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 NCT07609420, which also lists 4 linked publications.
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 20 Oct 2026.