Microbreaks and Intraoperative Exercises for Gynecologic Surgeons (MIGS Trial)
Phase: NA
Conditions: Work-related Injury, Physical Injury
Sponsor: University of Texas at Austin

 
 
Microbreaks and Intraoperative Exercises for Gynecologic Surgeons  
(MIGS Trial)   
 
 
 
 
August 12, 2022 
 
 

 
FORM: IRB Proposal - Standard Submission 
NUMBER 
VERSION DATE 
HRP-UT901 
8/12/2022 
 
The Effect of Intraoperative Exercises on Gynecologic Surgeons  
Page 1 of 29 
 
GENERAL STUDY INFORMATION 
 
Use for greater than minimal risk studies and minimal risk studies that fit into one or more expedited categories (see 
Section 5.3 of our Policies & Procedures  for details regarding expedited research). 
 
Do NOT submit this form if the study will qualify for exempt review, instead submit HRP-UT902 IRB Proposal – Exempt 
Submission Form found in the document Library.  
 
If you are only using secondary data that will not be initially collected solely for this research project, use HRP-UT903 
Template IRB Proposal Secondary Use form instead. 
 
For studies following a multi-center or sponsor protocol, please use this guidance to assist in your completion of this 
form. 
 
For questions regarding definitions, policies, or terms referenced below see the policies and procedures manual. 
 
Please note, Word online does not support Word checkboxes. Please download the file and use your desktop version of 
Microsoft Word. 
 
1 
Review Type (Choose one) 
 
Click on the check box (or double click and type an “X” if using Google Docs) the one review type that in the 
investigator’s opinion applies.  
 
Please note: Expedited Review does not refer to the timeliness of the review of your protocol, but specific 
categories of research defined by ORHP. If you would like help determining which type of review is most 
appropriate for your study please contact the Office of Research Support and Compliance:  
https://research.utexas.edu/ors/about-ors/contact-us/. 
 
Investigator’s assessment of review does not preclude the IRB from alternate determinations. In cases where the 
investigator and the IRB’s determination conflict, the IRB’s determination should be considered accurate. 
 
a ☐ 
 
Full Board Review – Greater than Minimal Risk Research 
b ☒ 
 
Expedited Review – Minimal Risk Research  
 
2 
Research Hypothesis 
To input text, click in the light grey area below. 
 
Short intraoperative 
 breaks and exercises will improve work-related discomfort among gynecologic 
surgeons. 
 

Page 2 of 29 
 
 
3 
Study Background 
To input text, click in the light grey area below. 
 
Work-related musculoskeletal disorders (MSDs) are prevalent among surgeons and 
include cumulative trauma disorders, repetitive strain disorders, repetitive motion 
disorders and overuse syndromes affecting the muscles, nerves, tendons, ligaments, 
cartilage, or spinal disks.1,2 A recent meta-analysis found that prevalence of work-
related pain ranged from 35%-60% across surgical subspecialties.3 The risk of these 
disorders may be higher depending on the route of surgery.4 Gynecologists are at risk of 
developing work-related MSDs. One study found that 86.7% of vaginal surgeons in 
urogynecology reported ever having work-related MSD.1 MSDs affect the health of 
individual surgeons and the stability of the surgeon workforce with up to 12% of 
surgeons with work-related MSD requiring a leave of absence, work restriction, or early 
retirement. 3 
 
Improving surgeon ergonomics and instituting intraoperative “microbreaks” and 
exercises may prevent work-related MSD among gynecologic surgeons. Prior studies 
have shown improvement in work-related discomfort or stress among surgeons with 
intraoperative breaks, but there are no prospective studies evaluating the impact of 
intraoperative exercises among gynecologic surgeons. One multi-center cohort study 
found that targeted stretch micro breaks diminished impact of pain on body parts, 
performance, and mental focus among surgeons in a variety of specialties.5 Another 
multi-center cohort study found that intraoperative exercise breaks significantly 
reduced discomfort with minimal impact on distractions or flow during surgery.6 A 
randomized control trial showed that intraoperative work breaks during complex 
laparoscopic surgeries reduced psychological stress without affecting performance or 
operative time.7 
 
 
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. 
 
 
 
 
4 
Design and Methodology 
 
Provide information regarding study design or data collection methodologies. Details regarding protocol specific 
research procedures will be discussed in a later section. 
 
To input text, click in the light grey area below. 

Page 3 of 29 
 
 
 
This is a prospective randomized trial to assess the effect of intraoperative microbreaks 
and exercises on gynecologic surgeon body discomfort. Surgery days among gynecologic 
surgeons will be randomized to include or not include intraoperative microbreaks with 
specific exercises. Data on body part discomfort and surgeon task load will be collected 
on each surgery day.  
 
 
5 
Data Analysis 
Describe the data analysis plan, including any statistical procedures or power analysis. 
 
To input text, click in the light grey area below. 
 
Design  
Describe the design of your study –  
 
 
 
Demographic and baseline characteristics  
The baseline survey includes information such as surgeon age, gender, weight, height, 
dominant hand, surgical volume, years practicing surgery, and activity level. 
 
Nordic Musculoskeletal Questionnaire 
At the beginning of the study, each participant will complete a baseline questionnaire 
adapted from the standardized Nordic Musculoskeletal Questionnaire (NMSQ)8 and a 
survey developed by Plerhoples et al.9   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.  
 
Primary outcome  
 
Body Part Discomfort (BPD) scale  

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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. Body part regions 
include neck, shoulders, arms, wrist/hands, upper back, low back, hips/thighs, knees, 
ankles/feet. Body part discomfort will be summarized by the mean severity of all ratings 
by the subjects, known as the Body Part Discomfort Severity (BPDS) index. This 
summary measure will be calculated from all of the individual BPD ratings for each 
posture in the present study. We will compare self-reported BPDS at the beginning of 
the surgery day to the end of the surgery day and calculate the change by subtracting 
the BPDS reported at the end of day minus beginning of day. When appropriate we will 
control for the total number of minutes spent in surgery during the day. 
 
Secondary Outcome:  
Surgery Task Load Index (SURG-TLX) 
Similar to the BPD, we will collect data on a modified SURG-TLX on each of the eligible 
surgery days.  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. Each of the 6 areas is rated on a scale of 0 to 100, which is added to 
generate a sum score. The sum score will then be compared across surgery days with 
and without the intervention. 
 
Data will also 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 (i.e. bladder/bowel injury, large vessel injury, transfusion, 
allergic reaction, difficulty ventilating, ICU admission). 
 
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. The exit survey with include questions about the participants 
experience performing the exercises including ease of performing exercises and 
incorporating into the surgical day. 
 
Randomization  
To randomize surgeons, we will first construct Williams squares where exercise follows 
no exercise (and vice versa) the same number of times.10 After the Williams squares are 
constructed and selected, individual sequences are randomly assigned to the surgeon. 
Sequence randomization will occur according to a predetermined computer-generated 
scheme prepared by a study statistician.  

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Statistical Analysis 
Descriptive statistics (means, standard deviations, frequencies) will characterize the 
sample to assess comparability of the intervention and control surgery days.  
Chi-square test or Fisher’s exact test will be used for categorical variables. Continuous 
variables will be examined for normality using the Shapiro-Wilk test; normally 
distributed continuous variables will be compared using the Student’s t-test and those 
non-normally distributed will be compared using the Mann-Whitney U test. We will use 
linear mixed models to test for an association between BPDS and the targeted micro 
breaks/exercise intervention across surgery days. We will exclude surgeons who do not 
provide self-reported BPDS data on both days for a certain body part.  
 
 
Power analysis: 
Sample size estimations were conducted using G*Power.  We utilized the research by 
Park et al (2017) to estimate the effect of intraoperative microbreaks and exercises on 
surgeon body discomfort. Park et al (2017) reported differences in body discomfort 
between surgeons who completed the intraoperative microbreaks/exercises and the 
control group that ranged from d=0.00 to d=0.48. Using G*Power, we computed the 
required sample size to detect a medium effect with the specified parameters: 
power=0.85, α=.05, f=0.25, and measurements = 10. This yielded a total sample size of 
at least 20 surgeons, where each surgeon completes 10 surgery days with the 
intervention and 10 surgery days without the intervention, with a minimal total of 20 
surgery days. 
 
Table 1. Power and sample size estimations for a within-subject design  
Cohen's f 
f=0.1 
small 
f=0.15 
f=0.20 
f=0.25 
medium 
f=0.30 
f=0.35 
f=0.40 
large 
total sample size 
power 
10 
0.12 
0.23 
0.41 
0.62 
0.8 
0.9 
1.0 
15 
0.16 
0.36 
0.62 
0.85 
1.0 
1.0 
1.0 
20 
0.21 
0.49 
0.79 
0.95 
1.0 
1.0 
1.0 
25 
0.27 
0.60 
0.89 
0.99 
1.0 
1.0 
1.0 
STUDY ELEMENT IDENTIFICATION 
6 
Study Elements 
 
Click on the check box (or double click and type an “X” if using Google Docs) each procedure included in your 
study. 

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A full description of all study procedures should be provided in the Procedures (Details) section below and/or the 
applicable supplement form. 
 
 
 
☐ 
 
Bio-specimens 
☐ 
 
Biometrics 
☐ 
 
Registry or Repository 
 
☐ 
 
Focus Group 
☐ 
 
Genetic Analysis 
☐ 
 
Genomic Data Sharing 
 
☐ 
 
International 
Research 
☒ 
 
Interview/Survey 
☐ 
 
MRI 
 
☐ 
 
Protected Health 
Information 
☒ 
 
Observation 
☐ 
 
Radioactive Material/PET/Nuc. 
Med 
 
☒ 
 
Record Review 
☐ 
 
Sensors  
(Externally Placed) 
☐ 
 
Sensors  
(Inserted) 
 
☐ Video/Audio 
Recording 
☐ 
X-Ray/CT 
 
 
 
7 
Study Intervention 
 
Click on the check box (or double click and type an “X” if using Google Docs) if you will implement any of the 
following interventions. 
 
A full description of all study interventions should be provided in the Procedures (Details) section below and/or 
the applicable supplement form. 
 
 
 
☒ Behavioral 
☐ Device 
☐ Drug/Biologic 
 
 
8 
Clinical Trial  
 
Click on the following check box (or double click and type an “X” if using Google Docs) if the research meets the 
below definition of a clinical trial.  
 
 
 
☒ This study meets the definition of a clinical trial according to clinical trials.gov in 
that it involves one or more human subjects who are prospectively assigned to 
one or more interventions (which may include placebo or other control) to 
evaluate the effects of those interventions on health-related biomedical or 
behavioral outcomes. 
 
 
9 
Additional Oversight  
 
Click on the check box (or double click and type an “X” if using Google Docs) each activity that requires oversight 
from additional UT committees.  
 

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☐ Energy introduced 
to the subject 
(electrical, 
magnetic, light) 
☐ Human embryonic, 
human induced 
pluripotent, or human 
totipotent stem cells; 
or human gametes or 
embryos 
☐ Radiation exposure without 
direct clinical benefit 
 
☐ 
Biological Samples, Biohazards, Recombinant DNA, or Gene Transfer  
 
 
If biological samples are used and stored on UT campus IBC approval is needed. 
 
a 
☐ 
Biological samples collected will not be stored on UT sites and another 
agency has responsibility for biospecimen safety. 
 
b 
IBC Protocol Number 
To input text, click in the light grey area below. 
 
 
 
10 Alternatives to Participation in This Study 
To input text, click in the light grey area below. 
 
Participants are free to not participate in the study.  
 
 
 
 
STUDY PROCEDURE DESCRIPTION  
11 Procedure Description 
 
Describe all study procedures, including a step-by-step outline of what participants will be asked to do or how 
data will be used. Be sure to describe all of the following in detail, as applicable: 
 
- Provide a description of all research procedures being performed and when they are performed, in sequential 
order. 
- All research measures/tests that will be used and state if questions or measures are standardized or published 
(upload copies of all surveys, scripts and data collection forms) 
- Secondary data or specimens that will be obtained, how they will be collected, and how they will be used 
- Where each activity will take place, the duration of each, and who will perform each activity 
- Include time commitment of participants 
 
To input text, click in the light grey area below. 
 
 
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 

Page 8 of 29 
 
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)8 and a survey developed by Plerhoples et al.9 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.11,12 

Page 9 of 29 
 
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.13 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.  
 
Intervention (see PDF document and video attached) 
Chest and Shoulder Opener “Elbows in Pockets” 
Stand with feet no wider than hip width apart. Extend arms out in front, palms facing 
forward. Keep the glutes engaged and weight firmly placed through the heels. Take a 
deep inhale. Then exhale slowly while tilting your head backwards, pulling your elbows 
towards your glutes as if to place them in your back pockets. As you move, arch your 
back while pushing up through the sternum to engage your core muscles. As you are 
doing this, gently guide your elbows down and back, imagining you are placing them “in 
your pockets”. Allow the head to relax backwards. Hold for 2 seconds, remembering to 
breath, and slowly return back to a standing position. Repeat. 
 
Chin Tuck 
Look straight ahead. Pull the chin straight backwards towards the back of the neck while 
inhaling until a gentle stretch is felt in the back of the neck. Exhale as you come forward. 
The primary motion is pushing the entire head backwards, with only a slight tilt of the 
chin downwards. It can be help to practice this out of scrub. Doing this, you can place 
your finger on your and push straight backwards to guide your head in the appropriate 
motion. 
 

Page 10 of 29 
 
Neck Rotation 
Look straight ahead. Turn head to the right, hold for a moment. Return to center. Turn 
head to the left, hold for a moment. Return to center. 
 
Squat with Truncal rotation (Chair pose with prayer) 
With feet hip width apart, bring palms together in a prayer position. Deeply inhale, then 
slowly squat down pushing the buttocks back, as if sitting down in a chair while slowly 
exhaling. Avoid letting the knees in front of the ankles, and go only as low as can be 
maintained with control. Keep the chest up and slight arch to the back. Then, on an 
exhale slowly rotate the torso to the left as far as can be comfortably done without 
moving the hips and continuing to breath. Return to center, then do this motion to the 
right. Return to center, and rise to a stand. 
 
Forward Bend 
Stand straight up, feet hip width apart. Cross arms. Engage the glutes and arch the back. 
With a slight bend in the knees, inhale and then on your exhale hinge forward at the 
hips until a stretch is felt in the hamstrings or the low back. Avoid rounding the back and 
avoid bringing arms close to legs. Stand up slowly keeping the glutes engaged and back 
straight.  
 
Data Collection Sheet: 
 
Baseline surgeon data: 
 
Age (years) 
 
Gender (male/female) 
 
Weight (lb.) 
 
Height (in.) 
 
Dominant hand (right/left) 
 
Years practicing surgery since residency 
 
Number of cases performed per year 
 
Number of hours exercising per week in the past month (hrs) 
 
 
 
Data for each surgery day: 
 
Surgeon BPDS score at beginning of day 
 
Surgeon BPDS score at end of day 
 
Surgeon SURG-TLX score at end of surgery day 
 
 
 
Data for each surgery: 
 
Hysterectomy performed 
 

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Route of Surgery 
 
Operative time (surgery start time to surgery stop time) 
 
Intraoperative complications  
 
 
 
Exit survey: 
 
The intraoperative exercises helped to reduce discomfort: (strongly 
disagree/disagree/agree/strongly agree) 
 
It was easy to understand the exercises as demonstrated in the 
video: 
(strongly disagree/disagree/agree/strongly agree) 
 
It was easy to understand the exercises as demonstrated in the PDF 
document: 
(strongly disagree/disagree/agree/strongly agree) 
 
I had to modify the exercises as demonstrated in the PDF 
document: 
(strongly disagree/disagree/agree/strongly agree) 
 
The intraoperative exercises did NOT disrupt the workflow in the 
operating room: 
(strongly disagree/disagree/agree/strongly agree) 
 
I will perform the intraoperative exercises (or some modification of 
them) in my future practice 
(strongly disagree/disagree/agree/strongly agree) 
 
I developed a work-related musculoskeletal disorder during the 
course of the study: 
(No/yes) 
 
Please provide any comments or suggestions to improve the 
feasibility of this research protocol from your perspective as a 
participant 
 
 
 
 
SUBJECT POPULATION 
12 
Protected Subject Populations 
Click on the check box (or double click and type an “X” if using Google Docs) each population, if they are 
specifically studied for this research. 
 

Page 12 of 29 
 
 
 
 
☐ 
 
Active military 
personnel 
☐ 
 
Children 
☐ 
 
Decisionally impaired adults 
 
☐ 
 
Emancipated 
minors 
☐ 
 
Fetuses 
☐ 
 
Individuals with limited 
English proficiency 
 
☐ 
 
Neonates 
☐ 
 
Pregnant Woman 
☐ 
 
Prisoners 
 
☐ 
 
UT Students 
☒ 
 
UT or Seton 
Staff/Employees 
 
13* Research Participant Information 
Describe the research population. 
 
*For multiple research populations (e.g., teachers, students, and parents), copy this section as necessary to 
describe your population. 
 
a Participant Group Name 
To input text, click in the light grey area below. 
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.  
 
b Minimum Age 
To input text, click in the light grey area below. 
18 
 
c Maximum Age 
To input text, click in the light grey area below. 
75 
 
d Inclusion Criteria 
To input text, click in the light grey area below. 
- 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. 
 

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SCREENING AND RECRUITMENT 
 
17 
Identification and/or Screening Procedures 
Describe the identification and/or screening procedures below. 
To input text, click in the light grey area below. 
Surgeons (residents, fellows, and attendings performing gynecologic surgery) will be 
identified from the Department of Women’s Health at the University of Texas at Austin 
e Exclusion Criteria 
To input text, click in the light grey area below. 
Participants will be excluded if they are unable to perform the exercises. 
 
f Additional Population Information 
To input text, click in the light grey area below. 
 
14 Total Sample Size 
To input text, click in the light grey area below. 
This study will recruit at least 20 surgeons. Each surgeon will complete at least 10 
surgery days with the intervention and at least 10 surgery days without the 
intervention, which will yield at least 20 surgery days.  
15 
Sample size rationale 
To input text, click in the light grey area below. 
Using G*Power, we computed the required sample size to detect a medium effect with 
the specified parameters: power=0.85, α=.05, f=0.25, and measurements = 10. This 
yielded a total sample size of at least 20 surgeons, where each surgeon completes 10 
surgery days with the intervention and 10 surgery days without the intervention, with a 
minimal total of 20 surgery days. 
16 
Identification and Screening 
 
Click on the check box (or double click and type an “X” if using Google Docs) if true. 
 
 
☐ This study involves obtaining information or biospecimens for the purpose of 
screening, recruiting or determining eligibility of prospective subjects prior to 
informed consent by either: 
1. 
Oral or written communication with the prospective subject or LAR 
2. 
By accessing records containing identifiable private information or stored 
identifiable biospecimens. 

Page 14 of 29 
 
Dell Medical School. Surgery days for each enrolled surgeon will be screened for 
inclusion. Surgery days containing at least one gynecologic surgery with two hours of 
total operating time in one day are eligible for inclusion. The eligible surgery days with 
then be randomized to standard surgery days or surgery days with the intervention 
(microbreaks with exercises).  
 
 
 
19 
Describe the recruitment process, including where recruitment will take 
place. 
Describe the recruitment procedures below. 
To input text, click in the light grey area below. 
Surgeons (residents, fellows, and attendings performing gynecologic surgery) will be 
recruited from the Department of Women’s Health at the University of Texas at Austin 
Dell Medical School. Information about the study will be presented to the gynecologic 
surgeons and all eligible surgeons will be asked to participate. Participation is voluntary 
and surgeons are not required to participate. 
 
OBTAINING INFORMED CONSENT 
18 
Recruitment Overview 
 
Click on the check box (or double click and type an “X” if using Google Docs) all recruitment methods utilized for 
this research. 
 
 
☒ 
E-mail 
☐ Flyer 
 
☒ 
In-Person 
☐ Letter 
 
☐ 
Social Media 
☐ Research Pool 
 
☒ 
Telephone/Text 
☐ Snowball Sampling 
 
☐ 
Web-post 
☐ Word of Mouth 
20 
Consent Overview 
 
Click on the check box (or double click and type an “X” if using Google Docs) all applicable items. 
 
 
☒ 
Obtaining Written Informed 
Consent 
☐ Requesting a Waiver of Documentation of 
Informed Consent 

Page 15 of 29 
 
 
 
 
 
☐ 
Requesting a Waiver of 
Informed Consent 
☐ Requesting an Alteration of the Required 
Elements of Informed Consent 
 
☐ 
Obtaining Child Assent 
☐ Obtain Consent Using a Short Form with a 
Witness 
21 
Consent and Assent Processes 
 
Provide a detailed description of the consent process including who will obtain consent, where, and when 
consent will occur in such a manner that participants have sufficient time for adequate consideration. 
 
To input text, click in the light grey area below. 
A member of the research team will obtain consent from all participating surgeons. 
Participants will have adequate time to review the consent form and consider 
participation. 
 
22 
Consent and Translation 
 
Click on the check box (or double click and type an “X” if using Google Docs) to indicate that consent will be 
translated. 
 
 
☐ 
The study population will likely include participants whose limited English 
speaking status requires translation of the consent form. 
 
 
Translation Process 
Click on the check box (or double click and type an “X” if using Google Docs) that best describes the translation 
process, either 21 or 22. 
 
23 
☐ 
The consent documents will be translated by a certified translator. 
 
24 
☐ 
A non-certified translator will translate the consent documents. 
If selected, complete the next two questions below. 
 
i Describe the translator’s qualifications 
To input text, click in the light grey area below. 
 
 
ii ☐ 
Another individual will confirm that the translation is accurate and 
appropriate. 
 
Waiver of Documentation of Informed Consent  
 
To approve a waiver of documentation of informed consent, one of the following options below must be 
justified by the researcher. 
 

Page 16 of 29 
 
Only complete the sections below if requesting a waiver of documentation of informed consent. If not 
requesting a waiver of documentation of consent, skip to 27. 
 
Please choose one waiver option and provide additional information as prompted. The Office of Research 
Support and Compliance recommends using Waiver Option 2 in most cases. 
 
25 
Waiver Option 1 
 
Provide confirmation for the following criteria and follow the additional instructions. 
 
Additional Instructions: 
1. Include this choice in the informed consent form.  
2. Articulate the destruction process for signed consent forms in the privacy and confidentiality section. 
 
Click on the check box (or double click and type an “X” if using Google Docs). 
  
a ☐ 
 
The only record linking the subject and the research would be the consent 
document. 
b ☐ 
 
The principal risk would be potential harm resulting from a breach of 
confidentiality. 
c ☐ 
 
Each subject will be asked whether the subject wants documentation linking the 
subject with the research, and the subject’s wishes will govern. 
26 
Waiver Option 2 
Provide confirmation for the following criteria and follow the additional instructions. 
 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
a ☐ 
 
The study is minimal risk. 
b ☐ 
 
Written consent would not be required outside the research context. 
27 
Waiver Option 3 
Provide confirmation for the following criteria and provide additional information as requested. 
 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
a ☐ 
 
The subjects or legally authorized representatives are members of a distinct 
cultural group or community in which signing forms is not the norm 
b Describe the cultural group or community. 
To input text, click in the light grey area below 

Page 17 of 29 
 
 
 
 
c ☐ 
 
The research presents no more than minimal risk of harm to subjects. 
d ☐ 
 
There is an appropriate alternative mechanism for documenting that informed 
consent was obtained. 
e Describe mechanism for documenting that informed consent was obtained 
To input text, click in the light grey area below 
 
 
 
Waiver or Alteration of Informed Consent  
 
To approve a waiver or alteration of informed consent all of the following criteria below must be justified by the 
researcher. 
 
Only complete the sections below if requesting a waiver of informed consent.  If not requesting a waiver or 
alteration of consent, skip to 31. 
 
28 
The research involves no more than minimal risk to the subjects. 
To input text, click in the light grey area below 
 
 
 
29 
The waiver or alteration will not adversely affect the rights and welfare of the 
subjects. 
To input text, click in the light grey area below 
 
 
 
30 
The research could not practicably be carried out without the waiver or alteration (it 
is impracticable to perform the research if obtaining informed consent is required and 
not just impracticable to obtain consent). 
To input text, click in the light grey area below 
 
 
 
31 
If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format. 
To input text, click in the light grey area below. 

Page 18 of 29 
 
 
 
 
 

Page 19 of 29 
 
 
BENEFITS 
36 
Benefits to Society 
Describe the scientific and societal benefit(s) below. 
 
To input text, click in the light grey area below. 
This study may provide a model for intraoperative breaks and exercises that 
gynecologic surgeons can use to decreased work-related discomfort. This could 
potentially mitigate the risk of work-related musculoskeletal disorders and the impact 
these conditions have on the workforce.  
 
 
Benefits to Participants 
Click on the applicable check box (or double click and type an “X” if using Google Docs). 
 
37 
☐ 
There is no anticipated direct benefit to participants. 
 
Deception and Debriefing 
Only complete the sections below if requesting an alteration of informed consent that involves deceiving 
research participants. If this study does not involve deception, skip to 35. 
 
See IRB Policies and Procedures Section 15 for a description of deception. 
 
 Click on the check box (or double click and type an “X” if using Google Docs).  
32 
☐ It is appropriate to provide additional pertinent information to the subject after 
research activities are complete (e.g., the researcher needed to deceive to subject 
to the nature of the study). 
33 
☐ Research participants will have the opportunity to withdrawal their data during 
the debriefing. 
34 
Describe the nature of deception and why it is necessary to conduct the research. 
To input text, click in the light grey area below. 
 
 
35 
Describe debriefing procedures. 
To input text, click in the light grey area below. 
 
 

Page 20 of 29 
 
38 
☒ 
There are anticipated benefits to participants. 
 
39 
If applicable, describe the potential direct benefits to participants. 
To input text, click in the light grey area below. 
Participants may directly benefit from the intervention and may experience decreased 
work-related pain or discomfort.  
 
RISKS 
40 
Describe the risks associated with each activity in this research 
To input text, click in the light grey area below. 
Participants are at risk for musculoskeletal injury from the exercises and stretches that 
are performed in this study.  
 
Surgeries performed during this study may include a surgical lasting approximately 1.5-
2 minutes. This could potentially increase the operative time of procedures, although 
prior studies have shown that there is no significant difference in operative time with 
the institution of microbreaks7.  
 
 
41 
Describe how each risk is mitigated/minimized. 
To input text, click in the light grey area below. 
The risk of musculoskeletal injury are mitigated by ensuring that exercises and 
stretches included in this study are gentle and can be performed with minimal strain 
and exertion. The exercises were developed with the assistance of a physician 
specialized in Physical Medicine and Rehab. 
 
To ensure that surgical microbreaks do not interfere with patient safety, microbreaks 
with exercises will only be performed if it is safe. Surgeons will remain sterile during 
the microbreak and can respond promptly to any patient concerns during the 
microbreak. The surgeon can stop or skip microbreaks at any point in the study if it is 
deemed unsafe.  
 
 
 
Data Safety Monitoring 
For additional information regarding data safety monitoring boards and data safety monitoring plans, please 
see Section 21 of our Policies and Procedures. 
 
Click on the check box (or double click and type an “X” if using Google Docs). 

Page 21 of 29 
 
 
42 
☒ 
In the investigator’s opinion, this study is minimal risk and does not require a 
Data Safety Monitoring Plan (DSMP) or a Data Safety Monitoring Board 
(DMSB). 
PLEASE NOTE: The IRB may determine minimal risk studies do require data safety monitoring under 
certain circumstances (e.g., if there is a known risk with an expected frequency).  
 
43 
☐ 
This study does not have a Data Safety Monitoring Board, but researchers have 
an internal plan/policy to monitor for safety. 
Complete Data Safety Monitoring Details (44-51). 
 
44 
☐ 
This study has a Data Safety Monitoring Board (DSMB). 
Complete Data Safety Monitoring Details (44-51) or upload this study’s Data Safety Monitoring Board’s 
charter. 
 
 
Data Safety Monitoring (Details) 
 
45 
How is safety information collected? 
To input text, click in the light grey area below. 
 
 
 
46 
When will safety data collection start (for each participant or for the whole study, as 
applicable)? 
To input text, click in the light grey area below. 
 
 
 
47 
How frequently will safety data be collected? 
To input text, click in the light grey area below. 
 
 
 
48 
Who will review the data for safety? 
To input text, click in the light grey area below. 
 
 
 
49 
How frequently will data be monitored for safety concerns? 
To input text, click in the light grey area below. 
 
 
 

Page 22 of 29 
 
50 
What data will be reviewed? 
To input text, click in the light grey area below. 
 
 
 
51 
State the frequency or periodicity of the review of cumulative data? 
To input text, click in the light grey area below. 
 
 
 
52 
State any conditions that would trigger an immediate suspension of the research. 
To input text, click in the light grey area below. 
 
 
 
 
 
Early Withdrawal 
Only complete this section if there are planned conditions under which a participant will be withdrawn from 
the study. If not applicable, skip to 56. 
 
Include this information in your consent form. 
 
 
 
53 
List the criteria for withdrawing individual participants from the study (e.g., safety 
or toxicity concerns, emotional distress, inability to comply with the protocol, or 
requirements from study sponsor). 
To input text, click in the light grey area below. 
 
Participants that develop a work-related or sports-related injury during study period 
must withdraw to prevent worsening of injury from exercises/stretches required as 
part of the study. 
 
 
54 
Describe any necessary procedures for ensuring the safety of a participant who has 
withdrawn early. 
To input text, click in the light grey area below. 
 
If a participant develops a work-related or sports-related injury as defined by the 
above criteria, he or she should withdraw from the study and follow-up with a 
provider regarding the injury. 
 
 

Page 23 of 29 
 
55 
Describe any pre-specified criteria for stopping or changing the study protocol due 
to safety concerns. 
To input text, click in the light grey area below. 
 
There is no pre-specified criteria. 
 
REQUIRED DISCLOSURES 
 
 
PRIVACY AND CONFIDENTIALITY 
Required Consent Disclosures  
Identify each element below that may require additional information to be disclosed in the consent form. 
 
Click on the check box (or double click and type an “X” if using Google Docs).  
 
56 
☐ 
It is reasonable that researchers could discover or suspect child or elder abuse. 
57 
☐ 
It is reasonable that researchers could learn of an incident that could require 
reporting under Title IX. 
58 
☐ 
It is reasonable that researchers could discover incidental findings or other 
information of medical interest about a participant's previously unknown 
condition. 
59 
Articulate methods for addressing and reporting incidental findings, if applicable. 
To input text, click in the light grey area below. 
 
 
60 
Privacy 
Describe how you will protect the identity and privacy of study participants during each phase of research. 
Privacy focuses on the individual participants rather than data. In this section, researchers should focus on 
issues such as where research activities take place and how participant involvement is protected from non-
participants. 
 

Page 24 of 29 
 
 
 
Describe methods to ensure participants’ privacy during identification, recruitment, screening, the consent 
process, the conduct of the study, and dissemination of data. 
 
To input text, click in the light grey area below. 
 
Surgeons (residents, fellows, and attendings performing gynecologic surgery) will be 
identified from the Department of Women’s Health at the University of Texas at Austin 
Dell Medical School. Participants with be introduced to the study and interested 
participants will be assessed for inclusion. Written informed consent will be obtained 
by the PI.  
 
Data will be collected and stored in our institution’s REDcap, a secure electronic 
application for research. 
 
UT Austin policies for Protected Health Information will be followed. There will not be 
any patient PHI data collected in this study however. There will be a spreadsheet 
source to de-identify the participants that will be kept on a password protected, 
encrypted USB drive with access only by the fellow collecting the data. All participant 
data will be deidentified as it is stored in REDcap.  Note, the participants are not 
patients. The data will be kept for the required 6 years after completion of the study 
and then destroyed. 
Confidentiality and Data Security Plan 
Click on the check box (or double click and type an “X” if using Google Docs) that best describes the 
confidentiality and data security plan and provide additional details regarding how you will protect the 
confidentiality of data or address confidentiality concerns.  
 
61 
☒ Identifiers will be coded to protect confidentiality. 
 
61a If true, state how data is coded and where identifiers are stored. 
To input text, click in the light grey area below. 
UT Austin policies for Protected Health Information will be followed. There will not 
be any patient PHI data collected in this study, however. There will be a 
spreadsheet source to de-identify the participants that will be kept on a password 
protected, encrypted USB drive with access only by the fellow collecting the data. 
All participant data will be deidentified as it is stored in REDcap. Note, the 
participants are not patients. The data will be kept for the required 6 years after 
completion of the study and then destroyed. 
 
62 
☒ Identifiable data will be destroyed. 
 

Page 25 of 29 
 
 
 
64 Data Access 
 
Click on the check box (or double click and type an “X” if using Google Docs) for each group of individuals that 
will have access to study data. 
 
If you plan on creating a repository, complete the repository form as well. 
 
 
☒ Study Team 
Members 
☐ External Collaborators 
☐ Data coordinating center 
 
☐ Sponsor 
☐ Future Sharing with 
other researchers 
 
☐ Others 
Describe below. To input text, click in the light grey area below. 
 
62a If true, describe destruction plan and timeline 
To input text, click in the light grey area below. 
The data will be kept for the required 6 years after completion of the study and 
then destroyed. 
 
63 
☐ Identifiable data will not be destroyed. 
 
63a If true, provide rationale for retaining identifiable data indefinitely. 
To input text, click in the light grey area below. 
 
65 
Describe data sharing plan for each group checked above and state whether 
researchers plan on sharing identifiable, coded, or de-identified data 
To input text, click in the light grey area below. 
Study team members will have access to deidentified data. Data will not be shared with 
any other institution or non-study team members. 
Certificate of Confidentiality  
Click on the check box (or double click and type an “X” if using Google Docs) to identify each element below that 
may require additional information to be disclosed in the consent form. 
 
If a Certificate of Confidentiality is not applicable for this study, skip to 68. 
 
66 
☐ The study requires a Certificate of Confidentiality. 
67 
☐ NIH has issued a Certificate of Confidentiality for this study. 

Page 26 of 29 
 
COMPENSATION AND COSTS 
 
☐ 
Cash 
☐ Check 
☐ Gift Card 
 
☐ 
Course Credit 
☐ ClinCard 
☐ Tango Card 
 
☐ 
Other 
Describe, To input text, click in the light grey area below. 
 
 
 
68 
☐ A Certificate of Confidentiality has not been obtained, but there are plans to 
apply for one. 
Compensation  
Click on the check box (or double click and type an “X” if using Google Docs). 
 
69 
☐ Subjects receive compensation. 
70 
☒ Subject will not receive compensation. 
Skip to question 74 if subjects will not receive compensation. 
71 
Total Amount of Compensation 
To input text, click in the light grey area below. 
 
 
72 
Type of Compensation 
Click on the check box (or double click and type an “X” if using Google Docs) for each form of compensation that 
will be provided. 
 
73 
Proration Schedule 
To input text, click in the light grey area below. 
 
74 
☐ Amount of compensation and its form is reasonable for this population for the 
activities requested of them. 
75 
Costs 
 
Click on the check box (or double click and type an “X” if using Google Docs) each applicable item regarding 
costs. 
 
 
☒ 
Participants will have no costs associated with this study 

Page 27 of 29 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
☐ 
Standard of care procedures 
contributing to study data 
 
☐ Research procedures not associated with 
standard of care 
 
☐ 
Administration of drugs / 
devices  
☐ Study drugs or devices 
 
☐ 
Transportation and parking  
76 
Describe all costs below. 
To input text, click in the light grey area below. 
 
 
 

Page 28 of 29 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
References: 
 
1. Kim-Fine S, Woolley SM, Weaver AL, Killian JM, Gebhart JB. Work-related musculoskeletal disorders 
among vaginal surgeons. Int Urogynecol J. 2013;24(7):1191-1200. 
2. Catanzarite T, Tan-Kim J, Menefee SA. Ergonomics in gynecologic surgery. Curr Opin Obstet Gynecol. 
2018;30(6):432-440. 
3. Epstein S, Sparer EH, Tran BN, et al. Prevalence of work-related musculoskeletal disorders among 
surgeons and interventionalists: a systematic review and meta-analysis. JAMA Surg. 
2018;153(2):e174947 
4. Plerhoples TA, Hernandez-Boussard T, Wren SM. The aching surgeon: a survey of physical discomfort 
and symptoms following open, laparoscopic, and robotic surgery. J Robotic Surg. 2012;6(1):65-72. 
5. Park AE, Zahiri HR, Hallbeck MS, et al. Intraoperative “micro breaks” with targeted stretching enhance 
surgeon physical function and mental focus: a multicenter cohort study. Ann Surg. 2017;265(2):340-
346. 
6. Hallbeck MS, Lowndes BR, Bingener J, et al. The impact of intraoperative microbreaks with exercises on 
surgeons: A multi-center cohort study. Appl Ergon. 2017;60:334-341. 
7. Englemann C, Schneider M, Kirschbaum C, et al Effects of intraoperative breaks on mental and somatic 
operator fatigue: a randomized clinical trial. Surg Endosc 2011; 25:1245–1250. 
8. Kuorinka I, Jonsson B, Kilbom A, et al. Standardised Nordic questionnaires for the analysis of 
musculoskeletal symptoms. Appl Ergon. 1987;18(3):233-237.  
9. Plerhoples TA, Hernandez-Boussard T, Wren SM. The aching surgeon: a survey of physical discomfort 
and symptoms following open, laparoscopic, and robotic surgery. J Robotic Surg. 2012;6(1):65-72. 
10. Jones B, Kenward MG. Design and analysis of cross-over designs, 2nd edn. Chapman and Hall, London. 
2003 
11. Corlett EN, Bishop RP. A technique for assessing postural discomfort. Ergonomics. 1976;19(2):175-182. 
12. Olendorf MR, Drury CG. Postural discomfort and perceived exertion in standardized box-holding 
postures. Ergonomics. 2001;44(15):1341-1367. 
13. Wilson MR, Poolton JM, Malhotra N, Ngo K, Bright E, Masters RSW. Development and validation of a 
surgical workload measure: the surgery task load index(Surg-tlx). World J Surg. 2011;35(9):1961-1960.  
 
 
 

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