Utilization of the Mirror During Pelvic Exams: Does it Reduce Patient Vulnerability and Discomfort?
Conditions: Pelvic Exam
Sponsor: TriHealth Inc.

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RESEARCH PROTOCOL 
 
Date 
 5-15-19 
Title 
Utilization of the mirror during pelvic exams: Does it reduce patient 
vulnerability and discomfort? 
Principal Investigator 
Rachel Pauls, MD 
Sub-Investigators 
Tiffanie Tam, MD; Austin Hill, MD; Steven D. Kleeman, MD; Catrina 
C. Crisp, MD MSc; Jennifer Yeung, DO; Emily Aldrich, MD 
Research Specialist 
Eunsun Yook, MS 
Department 
Department of OB/Gyn, Division of Urogynecology and 
Reconstructive Pelvic Surgery 
Hatton # 
18-107 
IRB Review Type: 
 
 Exempt 
 
 Expedited  
 Full Board 
 
Purpose of Study 
Primary Aim:  
 
To determine if using a mirror during the patient’s pelvic examination (MPE) decreases 
patients’ degree of vulnerability and discomfort. 
Secondary Aims: 
 To assess patient degree of anxiety, sense of control, and embarrassment during pelvic 
exam with and without the mirror.    
 To assess patient awareness of personal pelvic anatomy and diagnosis following pelvic 
exam with and without the mirror.   
 To assess patient willingness to have mirror during each subsequent pelvic exam  
 To assess patient satisfaction with their exam, with and without mirror. 
 To describe any differences between patients that agree to use of the mirror for their 
exam compared to those who refuse the mirror. 
 To determine if implementing the MPE increases average length of time of pelvic 
examination. 
 
Hypothesis or Research Question  
 We hypothesize that the MPE will decrease the level of vulnerability and discomfort 
experienced during the pelvic examination.  
 
Background 
In Obstetrics and Gynecology and its gynecologic subspecialties, the pelvic examination is 
routine practice for screening and diagnostic purposes. Nevertheless, due to their intimate 
nature, pelvic examinations may result in loss of control, embarrassment, discomfort and 
anxiety [1-3]. Patients that present for urogynecologic care are a unique subset of women due 
to their advanced age, and nature of their disorder.  As such, these patients may be more likely 
to express anxiety and concern about their visit [3]. 
 

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With the trend of hospital improvement and quality, patient centered care and experience are 
now a main topic of improvement. The environment in the outpatient setting is different from 
that of an inpatient setting however; the patient’s experience is just as complex. Patients who 
feel emotionally comfortable are more likely to feel a greater sense of empowerment, 
enablement and engagement [4]. This is intertwined with patient participation and ultimately 
affects the patient experience [5]. 
 
The mirror pelvic exam (MPE) has been a proposed technique to decrease patient anxiety and 
improve comfort during an already uncomfortable examination. However, little research has 
focused on this modality to date.  An early report from the 1970’s described 90% of the 
patients felt more relaxed by utilization of the mirror and 76% revealed they would like a 
gynecologic problem demonstrated with a mirror [6]. A small study performed at California 
Polytechnic State University studied 15 females who underwent an MPE. Results were 
favorable revealing that 67% of the patients aged 18-26 years were more relaxed and had less 
discomfort whilst using the MPE. Additionally, it was found that 100% of the patients would like 
to have the mirror used in the future if they were to experience a gynecological problem and 
92% would recommend this to a friend [7].  
 
To date, there have been no trials regarding the utility of the MPE in a population with 
prolapse, incontinence or pelvic floor disorders. By studying this tool, we could understand 
better the utility of the MPE and discover if there is a specific patient population or situation in 
which this tool should be offered to ease patients’ sense of vulnerability, pain, and anxiety. 
 
Research Plan   
 Study Design  
Prospective Two-cohort Study  
 Setting for the study 
o All new patients to Cincinnati Urogynecology Associates, TriHealth presenting to 
one of four outpatient clinics (Clifton, West Chester, Kenwood, Anderson) will be 
eligible. 
o They will then be approached by either a research coordinator, attending 
physician or fellow in the exam room or in the research coordinator’s office prior 
to the start of their visit and offered enrollment.   
o If they agree to participate they will answer a brief questionnaire about 
demographics, personal experience with pelvic exam, the purpose of their visit 
and whether they would agree to have a mirror utilized during their pelvic exam 
that day. 
o If they agree to have a mirror used, then they will undergo the examination with 
the use of a mirror during the physician examination of the pelvic area, and 
receive information about the anatomy being shown.  No other changes will be 
made to the exam performed. 
o If they decline a mirror then they will undergo our standard pelvic examination. 
o All enrolled patients will then be given a questionnaire at the completion of their 
pelvic exam.   

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 Participants 
o Study population: All women 18 years of age to 80, who undergo pelvic exam by 
a physician at Cincinnati Urogynecology Associates, TriHealth will be approached 
for recruitment. 
o Inclusion/Exclusion criteria: 
 Inclusion 
 Adults 18 years of age to 80 
 New patients undergoing a pelvic exam performed by a physician 
at Cincinnati Urogynecology Associates, TriHealth    
 Exclusion 
 Existing patients 
 Unwillingness to participate in the study 
 Physical or mental impairment that would affect the subject’s 
ability to visualize the mirror during examination or to complete 
questionnaires 
 Inability to understand English 
o Sample size 
 A sample size was calculated to be 68 patients in each arm based on the 
following: 
 A prior study by Seehusen D. et al, evaluated the vulnerability and 
discomfort level in patients who underwent a pelvic exam using 
stirrups or no stirrups. Because there are no prior studies that 
have evaluated vulnerability or discomfort using the mirror during 
pelvic examination, this study was used to develop a sample size 
[8].  
 The difference in mean VAS on level of vulnerability for two 
groups was selected to be 10.5 mm with SDs for 16.3 and 25.8 
with/without intervention, respectively.[8] 
 Two group Satterthwaite t-test with a 0.05 two-sided significance 
level was used for sample size calculation.     
 The power was set at 80 %.  
 Assuming an estimated drop-out rate of 15%, the number of 
patient enrollment per arm was set to 80, for a total of 160 
patients.  
 
 Data Collection 
o Primary Outcome:  

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 Patient’s level of vulnerability and discomfort before and after the pelvic 
exam.    
o Secondary Outcomes:  
 Patient’s sense of loss of control, anxiety and embarrassment during the 
pelvic exam.  
 Patient’s level of understanding of pelvic anatomy and diagnosis after the 
pelvic exam.  
 Changes in the time of the examination as calculated by time performing 
the pelvic exam (will be performed using a timer in the room). 
 Differences in demographics and medical history between those that 
decline the MPE and those that consent to the MPE. 
 Patients’ overall satisfaction of the entire visit.  
 Likelihood of physician referral to friends or family. 
 Patients willingness to have the MPE during future visits. 
o General demographic data and medical data 
 DOB, age, race, weight, height, BMI, religion, education level, past 
medical history, date of exam, duration of exam, chief complaint on 
initial visit, sexual activity level, outcome of visit (ie. Surgical intervention, 
medical intervention, none). 
 
 Intervention or experimental aspect of the study 
o The patients will be addressed on their first visit in the exam room or in the 
research coordinator’s office  prior to the start of their visit. Each will be given a 
description of the study by a research coordinator, attending or fellow.  
o Once consent and enrolled, whether or not they refuse to have the mirror pelvic 
exam or not, they will be given a pre-examination questionnaire.  
o Of the patients who agree to have the mirror pelvic exam, they will then undergo 
routine pelvic examination by a physician with the usage of a mirror in the room. 
This mirror will be a roll-in mirror that is positioned in such a manner that 
provides the patient with adequate visualization of her female parts.  
o All physicians will be instructed on the terminology and descriptions to utilize 
with the exam to standardize the experience with the mirror. 
o The pelvic examination will be timed from the start of palpation of the external 
female genitalia and stopped at the time of last genital contact.  
o At the end of the visit, the patient will be given a questionnaire that 
characterizes her experience.   
 
 Statistical Analysis 
o Descriptive statistics will be generated for demographic information such as age, 
race, BMI, Parity. Continuous variables such as level of vulnerability, pain, and 
anxiety on VAS will be analyzed using independent samples t-tests or Mann-
Whitney U test for significant difference between groups. A multiple linear 
regression will be utilized for adjusting confounding variables. Categorical 
variables will be tested using the Fisher’s exact or Pearson Chi-square tests. 

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Ethical Considerations 
 Informed consent  
o Patients who agree to participate in the study will sign a written informed 
consent. They will be consented by one of the stated investigators or trained 
Research Nurse and they will receive a copy of the signed informed consent 
statements (ICS). A copy will be put in their medical file. 
 Privacy information 
o Extensive efforts will be made to ensure and maintain participant 
confidentiality. All identifying information will be maintained in a secure area 
at all times. Source documentation will be maintained in a separate folder. 
When documentation has to be made available for data analysis, copies of 
the source (Excel spreadsheets) with only Subject ID number visible and 
personal information obscured will be used. All communication between 
staff members regarding participant data will occur via the Subject ID 
number only. However, identifying information will be retained in the 
original/source documents. 
o The participant will be logged in the Excel spreadsheet and assigned a 
Subject ID number. Each participant will be assigned the next available 
Subject ID number. Once each Subject ID number has been assigned, it will 
not be reassigned. The Excel spreadsheet will be stored on a password 
protected, encrypted TriHealth computer for ten years following study 
closure, and then purged. 
 
 
Estimated Period of Time to Complete Study 
When will study begin? 
December 15th, 2018  
Protocol Development 
Completed 
November 5th, 2018  
Admin Review Time 
2 weeks   
IRB Approval 
December 18,2018   
Data collection 
Subjects to be enrolled starting January 1, 2019 
Data analysis 
January 2020  
 
 When and how will results be disseminated? 
 Submit for abstract presentation at national/international meeting and 
publication 
 

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References 
[1] Larsen, M. “Not so Bad after All..., Womens Experiences of Pelvic Examinations.” Family Practice, vol. 
14, no. 2, Jan. 1997, pp. 148–152., doi:10.1093/fampra/14.2.148. 
 
[2] Haar, Esther, et al. “Patientsʼ Attitudes toward Gynecologic Examination and to 
Gynecologists.” Medical Care, vol. 15, no. 9, 1977, pp. 787–795., doi:10.1097/00005650-197709000-
00006. 
 
[3] Bates, Carol K., et al. “The Challenging Pelvic Examination.” Journal of General Internal Medicine, vol. 
26, no. 6, Dec. 2011, pp. 651–657., doi:10.1007/s11606-010-1610-8. 
 
[4] Williams, Anne M, et al. “Further Psychometric Testing of an Instrument to Measure Emotional Care 
in Hospital.” Journal of Clinical Nursing, vol. 20, no. 23-24, Jan. 2011, pp. 3472–3482., 
doi:10.1111/j.1365-2702.2011.03846.x. 
 
[5] Williams, A M, et al. “Patient Evaluation of Emotional Comfort Experienced (PEECE): Developing and 
Testing a Measurement Instrument.” BMJ Open, vol. 7, no. 1, 2017, doi:10.1136/bmjopen-2016-012999. 
 
[6] Liston, Joneen, and Edward H. Liston. “The Mirror Pelvic Examination: Assessment in a Clinic 
Setting.” JOGN Nursing, vol. 7, no. 2, 1978, pp. 47–50., doi:10.1111/j.1552-6909.1978.tb00907.x. 
 
[7] Miller, G.D. The gynecological examination as a learning experience. J Am Coll Health 
Assoc. 1974;23:162–164.  
 
[8] Seehusen, Dean A, et al. “Improving Womens Experience during Speculum Examinations at Routine 
Gynaecological Visits: Randomised Clinical Trial.” Bmj, vol. 333, no. 7560, 2006, p. 171., 
doi:10.1136/bmj.38888.588519.55.