Intraoperative Exercises & Musculoskeletal Pain in Gynecologic Surgeons

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to evaluate the effect of intraoperative microbreaks and exercises on gynecologic surgeon body discomfort by conducting a randomized trial. We hypothesize that gynecologic surgeons will experience decreased pain on surgery days with intraoperative microbreaks and exercises without compromising overall surgical performance.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Physical Activity in Patients With Gynecological Surgery

NCT02025387

Women Who Underwent Midline Incision, Gynecological Surgery

COMPLETED NA

Pelvic Floor Dysfunction and Quality of Life in Patient Undergoing Gynecological Surgery

NCT06875635

Pelvic Floor Dysfunction

COMPLETED NA

Comparison of the Incidence of Shoulder Pain According to Postoperative Use of Abdominal Binder

NCT05043844

Shoulder Pain

UNKNOWN NA

Impact of Marking Surgical Incision on Patient's Abdomen

NCT01803334

Surgical Procedure

TERMINATED NA

Randomized Clinical Trial: Effect of an Exercise Routine on Postoperative Shoulder Pain in Laparoscopic Hysterectomy

NCT06195176

Postoperative Pain Laparoscopic Hysterectomy for Benign Conditions

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Potential participants include residents, fellows, and attendings performing gynecologic surgery (including benign gynecologists, gynecologic oncologists, minimally invasive gynecologists, and urogynecologists). We will recruit surgeons from the Department of Women's Health at the University of Texas at Austin Dell Medical School. Surgeons will need to have operated on average at least 2 days per month over the last 12 months. Written informed consent will be obtained. Eligible surgery days must include at least one surgery with total operative time of at least 2 hours. Surgeons will be excluded if they are unable to perform the exercises.

Upon agreement to participate in the study, surgeons will complete baseline questionnaires adapted from the standardized Nordic Musculoskeletal Questionnaire (NMSQ) and a survey developed by Plerhoples et al. The NMSQ is a validated questionnaire for the analysis of musculoskeletal symptoms and assesses for history of trouble (ache, pain, discomfort) in body part regions. The survey includes information such as surgeon age, gender, weight, height, dominant hand, surgical volume, years practicing surgery, and activity level.

Once participants are enrolled, all participant surgery days will be assessed for inclusion based on the inclusion criteria above. Surgery days will be randomized to surgery days with microbreaks and exercises and surgery days without microbreaks and exercises. The surgeon will be informed of the randomization assignment prior to the surgery day.

Surgery days randomized to intraoperative microbreaks and exercises will include standardized breaks lasting approximately 1.5-2 minutes. During these breaks, surgeons will perform a set of targeted stretches or exercises while remaining sterile. These exercises were developed with the assistance of a physician specialized in Physical Medicine and Rehab. The exercises will be performed just before surgical time-out, at a surgically safe and convenient time 45-75 mins after the start of the case and at the end of the case. A surgically safe and convenient time means the surgeon feels that it is safe to take an approximately 1.5-2 minute break during the procedure at that time. Surgeons will skip the microbreak if there is no surgically convenient or safe time during the case. Surgeons will stop the microbreak at any point if needed to ensure patient safety. The microbreaks performed during the surgery may add time to the surgery in approximately 1.5-2 minute increments, however prior studies have shown no difference in operative time with addition of microbreaks. Attached is a document outlining the exercises including photos with exercise cues and a video demonstrating the exercises. Participants will have access to these documents before and during the study.

On each surgery day, participating surgeons will complete the "Surgery Day Questionnaire" which will include the Body Part Discomfort (BPD) scale and Surgery Task Load Index (SURG-TLX). The Corlett and Bishop BPD Scale was originally created in 1976 and is a validated technique to assess work-related discomfort by body part regions. Another measure of work-related stress during surgery is the SURG-TLX. This is a validated tool based off the NASA-TLX used to assess overall workload including mental demands, physical demands, temporal demands, task complexity, situational stress, and distractions. At the beginning of all surgery days, the participating surgeon will complete a baseline BPD scale as the first part of the "Surgery Day Questionnaire". Following each surgery day, the surgeon will complete both the BPD scale and the SURG-TLX survey to complete the "Surgery Day Questionnaire" for that day. Participating surgeons are asked to inform the research team if they develop any new work-related injury during the study period.

Data will be collected from medical records about each surgery in the study. The following perioperative data will be collected: surgeries performed, operative time, and intraoperative complications.

At the conclusion of the study, an anonymous exit survey will be performed to give all participants an opportunity to provide feedback. Data will be collected on the results of the exit survey. All data will be collected and stored in our institution's REDcap, a secure electronic application for research.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Work-related Injury Physical Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Once participants are enrolled, all participant surgery days will be assessed for inclusion based on the inclusion criteria above. Surgery days will be randomized to surgery days with microbreaks and exercises and surgery days without microbreaks and exercises. The surgeon will be informed of the randomization assignment prior to the surgery day.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgery days with intraoperative microbreaks and exercises

Surgery days randomized to intraoperative microbreaks and exercises will include standardized breaks lasting approximately 1.5-2 minutes. During these breaks, surgeons will perform a set of targeted stretches or exercises while remaining sterile. The exercises will be performed just before surgical time-out, at a surgically safe and convenient time 45-75 mins after the start of the case and at the end of the case. A surgically safe and convenient time means the surgeon feels that it is safe to take an approximately 1.5-2 minute break during the procedure at that time. Surgeons will skip the microbreak if there is no surgically convenient or safe time during the case. Surgeons will stop the microbreak at any point if needed to ensure patient safety.

Group Type EXPERIMENTAL

Intraoperative microbreaks and exercises

Intervention Type BEHAVIORAL

Intraoperative microbreaks and exercises will include standardized breaks lasting approximately 1.5-2 minutes. During these breaks, surgeons will perform a set of targeted stretches or exercises while remaining sterile. Intervention exercises include: chest and shoulder opener "elbows in pockets," chin tuck, neck rotation, squat with truncal rotation (chair pose with prayer), and forward bend.

Surgery days without intraoperative microbreaks and exercises

Surgery days without intraoperative microbreaks and exercises will include no intervention. Surgeons will perform the surgeries as they are normally performed and surgeons will not take microbreaks or perform exercises.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intraoperative microbreaks and exercises

Intraoperative microbreaks and exercises will include standardized breaks lasting approximately 1.5-2 minutes. During these breaks, surgeons will perform a set of targeted stretches or exercises while remaining sterile. Intervention exercises include: chest and shoulder opener "elbows in pockets," chin tuck, neck rotation, squat with truncal rotation (chair pose with prayer), and forward bend.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Residents, fellows, and attendings performing gynecologic surgery (including benign gynecologists, gynecologic oncologists, minimally invasive gynecologists, and urogynecologists) who are able to perform the exercises.
* Surgery days must contain at least one gynecologic surgery with two hours of total operating time in one day.
* Surgeons will need to have operated on average at least 2 days per month over the last 12 months.