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Intraoperative Exercises & Musculoskeletal Pain in Gynecologic Surgeons (GynIEx)

Primary Purpose

Work-related Injury, Physical Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative microbreaks and exercises
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Work-related Injury

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. Exclusion Criteria: Participants will be excluded if they are unable to perform the exercises.

Sites / Locations

  • The University of Texas at AustinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Surgery days with intraoperative microbreaks and exercises

Surgery days without intraoperative microbreaks and exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Body Part Discomfort (BPD)
On each of the eligible surgery days, we will collect data on body part discomfort and surgical experience using the Body Part Discomfort (BPD) scale. The BPD scale measures body part discomfort using a 10-point scale (1 corresponds with no discomfort and 10 corresponds to maximum body discomfort) for body part regions.

Secondary Outcome Measures

Surgery Task Load Index (SURG-TLX)
The modified SURG-TLX will be evaluated at the end of each surgery day to assess participant experience throughout the surgery day. The SURG-TLX measures 6 areas: mental demands, physical demands, task complexity, situational stress, and distractions.
Perioperative data
surgeries performed, operative time, and intraoperative complications (i.e. bladder/bowel injury, large vessel injury, transfusion, allergic reaction, difficulty ventilating, ICU admission)

Full Information

First Posted
February 8, 2023
Last Updated
June 29, 2023
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT05761288
Brief Title
Intraoperative Exercises & Musculoskeletal Pain in Gynecologic Surgeons
Acronym
GynIEx
Official Title
Microbreaks and Intraoperative Exercises for Gynecologic Surgeons (MIGS Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work-related Injury, Physical Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery days with intraoperative microbreaks and exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgery days without intraoperative microbreaks and exercises
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intraoperative microbreaks and exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Part Discomfort (BPD)
Description
On each of the eligible surgery days, we will collect data on body part discomfort and surgical experience using the Body Part Discomfort (BPD) scale. The BPD scale measures body part discomfort using a 10-point scale (1 corresponds with no discomfort and 10 corresponds to maximum body discomfort) for body part regions.
Time Frame
On the day of surgery
Secondary Outcome Measure Information:
Title
Surgery Task Load Index (SURG-TLX)
Description
The modified SURG-TLX will be evaluated at the end of each surgery day to assess participant experience throughout the surgery day. The SURG-TLX measures 6 areas: mental demands, physical demands, task complexity, situational stress, and distractions.
Time Frame
On the day of surgery
Title
Perioperative data
Description
surgeries performed, operative time, and intraoperative complications (i.e. bladder/bowel injury, large vessel injury, transfusion, allergic reaction, difficulty ventilating, ICU admission)
Time Frame
On the day of surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. Exclusion Criteria: Participants will be excluded if they are unable to perform the exercises.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura M Kent, MD
Phone
4044887778
Email
mkent.laura@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Lasher
Phone
404-441-3186
Email
brooke.lasher@austin.utexas.edu
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brooke Lasher
Phone
404-441-3186
Email
brooke.lasher@austin.utexas.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1278144
Citation
Corlett EN, Bishop RP. A technique for assessing postural discomfort. Ergonomics. 1976 Mar;19(2):175-82. doi: 10.1080/00140137608931530. No abstract available.
Results Reference
background
PubMed Identifier
15676628
Citation
Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.
Results Reference
background
PubMed Identifier
21597890
Citation
Wilson MR, Poolton JM, Malhotra N, Ngo K, Bright E, Masters RS. Development and validation of a surgical workload measure: the surgery task load index (SURG-TLX). World J Surg. 2011 Sep;35(9):1961-9. doi: 10.1007/s00268-011-1141-4.
Results Reference
background

Learn more about this trial

Intraoperative Exercises & Musculoskeletal Pain in Gynecologic Surgeons

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