The Influence of Postoperative Environment on Patient Satisfaction and Perception of Care Following Pelvic Reconstructive Surgery
Phase: NA
Conditions: Postoperative Pain
Sponsor: TriHealth Inc.

Postoperative Environment 1 
RESEARCH PROTOCOL 
 
Date 
7/20/20 
Title 
The influence of postoperative environment on patient satisfaction 
and perception of care following pelvic reconstructive surgery 
Principal Investigator 
Rachel N. Pauls, MD 
Sub-Investigators 
Catrina Crisp MD MSc, Jennifer Yeung DO, Tiffanie Tam MD, 
Emily Aldrich MD 
Research Specialist 
Eunsun Yook MS,  
Department 
Department of OB/Gyn, Division of Urogynecology and 
Reconstructive Pelvic Surgery 
Hatton # 
17-076 
NCT # 
03379753 
 
Purpose of Study   
 To determine the influence of homeopathic therapies such as music therapy and 
images of calming nature scenes in their hospital suite following vaginal 
reconstructive surgery for pelvic organ prolapse on parameters of recovery such as 
pain, satisfaction and perception of care. 
o Primary Aim: To determine if patients following prolapse repair including 
vaginal vault suspension have decreased pain measured via a visual analog scale 
(VAS) on postoperative day one and just prior to discharge when exposed to the 
diad of music, and positive images compared to patients receiving standard care. 
o Secondary Aims: To determine if patients following prolapse repair including 
vaginal vault suspension have improved satisfaction scores and perception of care 
when exposed to the diad of music, and positive images compared to patients 
receiving standard care. 
 
Hypothesis or Research Question  
 We hypothesize that patients exposed to alternative therapies such as music, and 
calming nature scenes will have decreased VAS scores for pain following vaginal 
reconstructive surgery when compared to controls.  
 We further hypothesize that patients who experience the modified post-operative 
environment will report an improvement in overall satisfaction when providing their 

Postoperative Environment 2 
overall hospital rating and will be more likely to refer their friends to the hospital for 
care in the future, as measured by the HCAHPS and VAS satisfaction scores.  
 
Background 
  
Establishing an ideal environment to optimize healing is not a new concept.  In the late 1800’s, 
Florence Nightingale wrote about the importance of supportive spaces for patient care and 
recovery1.  Over the past decade, interest has grown in improving the patient experience.  As part 
of this movement, studies have sought to evaluate the mechanisms by which the postoperative 
environment affects a patient’s outcome and perception of healing.  A report written to the 
Center for Health Design found over 600 studies linked to hospital environment and its affect on 
patient satisfaction, stress, outcomes and perception of quality2.  Critical to the patient experience 
is reducing their pain, which in turn leads to improved satisfaction. Patient satisfaction has been 
shown to improve adherence to care plans, reduce 30-day readmission rates and decrease overall 
mortality3,4.  
 
Literature review reveals efforts by both medical and design teams towards improving the 
experience of the patient and developing an environment that promotes healing.  Changes to the 
physical environment have been shown to have an impact on satisfaction.  These parameters 
have included music and art.   
 
Considering alternative therapies, much energy has been devoted to the affect that music can 
have on satisfaction and pain control in the post-operative period.  A recent review in the Lancet, 
found 73 randomized controlled trials looking at how music can aid in postoperative recovery in 
adults.  They found that the choice of music, timing of delivery and duration of exposure varied.  
But the studies included, showed that music can consistently reduce pain measured by VAS 
scores, anxiety, analgesic utilization, and can help improve patient satisfaction with their care11.  
Music has specifically been shown to improve VAS scores for patients following open heart 
surgery when subjects listened for 30 minutes on post operative day one compared to control.  
Furthermore, patients recovering from spine surgery who had 30 minutes of music therapy while 
in the hospital showed significant improvements in their VAS scores over controls15.  

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Building on the patient surroundings, art has been shown to improve patient’s vital signs, clinical 
outcomes and diminished cortisol levels5.  Having a landscape on the wall of inpatient rooms in 
the critical care unit has been shown to decrease opiate utilization and lead to earlier discharges6-
8.  Landscapes displayed during bronchoscopy at John’s Hopkins showed significant decreases in 
patient VAS scores9. Finally, patients are more likely to refer others to seek care at facilities that 
display art10.  
 
Considering the effort that is now going into improving the patient experience and developing 
this theory of healing spaces, there has yet to be a randomized controlled trial evaluating these 
alternative therapies in the urogynecologic patient population.  Although each of these modalities 
appears beneficial, we believe that a combination of these would be even more useful.  Indeed, 
these treatments are also relatively easy to implement without undue cost or burden to the 
hospital.  Thus, this study seeks to apply music, and art to the post operative environment for 
patients recovering from major urogynecologic surgery, in an effort to determine if there is an 
affect on their VAS scores and satisfaction when compared to controls.   We also intend to 
document patient perceptions of their experience. 
 
Research Plan  
 Study Design  
o Randomized Controlled Trial  
 
 Setting for the study 
o Patients of Cincinnati Urogynecology Associates, TriHealth Inc, undergoing 
inpatient vaginal reconstructive surgery for pelvic organ prolapse at Good 
Samaritan Hospital or Bethesda North Hospital will be eligible for enrollment. 
o Subjects will be enrolled during their preoperative consent or in the preoperative 
holding area 
o Patients who enroll in the study will provide written informed consent 
o Following enrollment, a SNOSE will dictate to which group the patient has been 
randomized. 

Postoperative Environment 4 
 Intervention group:  
 Those patients randomized to experience a modified post-operative 
environment will be provided with a standard private hospital 
room with two portable modifications.   
 They will have access to a Bluetooth capable speaker with 
selections of music allowing them to play music or relaxation 
sounds of their choosing.  They will be asked to listen to a 
minimum of 30 minutes of music three times during their stay.  
Music will be played at a low enough volume to allow concurrent 
conversation.   
 Additionally, the room will be decorated with a wall hanging 
image of a soothing nature landscape.  The landscape will be hung 
on the wall near the foot of the bed throughout the participant’s 
length of stay.  
 
 Control group: 
 Those patients randomized to experience an un-modified post-
operative environment will experience a private hospital room at 
Good Samaritan or Bethesda North hospitals without alteration.  
 
o On  POD 1, following breakfast, patients will be asked to rate their pain using a 
VAS scale from 0-100 mm.   
o Prior to discharge they will complete a second VAS regarding their current pain.  
They will also complete VAS questions regarding satisfaction and overall pain 
during their hospital stay.  
o They will be asked two modified questions similar to the Hospital Consumer 
Assessment of Healthcare Providers and Systems survey (HCAHPS) to determine 
perception of care.  A modification is necessary because these questions cannot be 
utilized while patients remain admitted to the hospital per federal regulation. 
o They will be asked two questions regarding overall perception of care (VAS 0-
100mm) 

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o The intervention group will also be asked regarding their appreciation of music,  
and the landscape as a part of their healing experience.  
o At their 2 weeks postoperative follow-up appointment, they will be provided 
similar VAS questions for satisfaction and pain, followed by the unmodified 
HCAHPS questions.  They will also be asked to report their overall satisfaction 
with the results their surgery and their decision to have surgery.  
o The intervention group will be asked similar questions regarding their experience 
with music and landscape during their recovery. 
o Demographics, medical and surgical information, complications, postoperative 
narcotic use, voiding trial results, CBC, etc will be recorded from their chart.  
o Post-operative orders will be completed through a standardized order set which 
provide the standard of care for the post-operative management of patients having 
vaginal reconstructive surgery.  There will be no differences in these orders 
between intervention and control group with exception of the music and 
landscape.   
 
 
 Participants 
o Study population: All women 18 years of age or older, who undergo vaginal vault 
suspension in conjunction with pelvic organ prolapse reconstruction, with or 
without additional concomitant procedures by a physician at Cincinnati 
Urogynecology Associates, TriHealth for treatment of pelvic organ prolapse 
(POP) will be approached for recruitment at their office visit when they sign 
surgical consent or at the pre-operative holding area.   
o Inclusion/Exclusion criteria: 
 Inclusion 
 Adults 18-85 years of age 
 English speaking 

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 Undergoing surgery for pelvic organ prolapse to include an apical 
vaginal vault suspension by a physician at Cincinnati 
Urogynecology Associates, TriHealth  
 Concomitant procedures such as hysterectomy, suburethral sling, 
anterior or posterior colporrhaphy, bilateral salpingectomy or 
salpingooophorectomy will be included 
 Ability to complete the questionnaires and provide consent 
 Willingness to listen to music at the minimum recommended time 
intervals 
 Exclusion 
 Unwillingness to participate in the study 
 Physical or mental impairment that would affect the subject’s 
ability to utilize the modified environment such as deafness, 
blindness or dementia.  
 Patients who take daily narcotics or NSAIDS 
 Patients with history of Drug or Alcohol Abuse 
 Patients with chronic pain syndromes.  
 Non English speaking 
 Patients that do not undergo a vaginal apical suspension procedure 
 
o Sample Size 
 In the literature there does not exist a trial that has addressed these 
components in isolation or conjunction for patients undergoing pelvic 
reconstructive surgery.   
 Our sample size calculation took into account several factors, as well as 
our divisions’ prior experience with studies evaluating pain following this 
surgical approach. 
 In order to represent a clinically significant change in pain when using the 
VAS score, studies completed in emergency medicine looking at acute 
pain reported that a difference in the VAS score of 9-13 mm represents a 

Postoperative Environment 7 
true change12,13.  Other studies in gynecology has also confirmed that a 
difference between 10-20 mm may be clinically relevant following an 
intervention17,20-23 
 Previous studies looking at the effect of music on post-operative pain in 
other specialties have shown an average decrease in the VAS score of 7-
26mm11,14-16.  These studies do however display a variety in effect and 
differing standard deviations.  
 Review of referenced studies in a large meta-analysis published by Hole et 
al11 produced a heterogeneous population and varied results and sample 
sizes.   
 The most reliable statistics appear to be in a paper by   Cutshall16 et al, 
which reported results of an intervention of music for cardiac surgery 
patients in the ICU.  The data demonstrates  a narrow standard deviation 
and results in agreement with overall conclusion of the meta-analysis 
 Decrease in mean pain score was 1.4cm for their music group and 
0.4cm for the control group, with a difference of 10mm between 
the groups (SD was 1.4).  
 This study was therefore selected for calculation of our sample size.   
 We powered our study to detect a difference of 10mm in the postoperative 
VAS score between intervention and control groups. We deem this  
reasonable considering the review article by Hole11 reporting on 73 
randomized trials, found a mean overall difference in pain scores of 23mm 
between intervention and control groups.  
 Power Analysis 
 Our calculation demonstrated need to enroll 43 patients in each 
arm based on the following: 
o A difference of 1cm on subjects’ VAS scores for pain 
o Power at 90% 
o Standard deviation at 1.4 
o Effect size at 0.714 

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o Assuming an estimated loss rate of 15%, the number of 
patient enrollment per arm was set to 51, for a total of 102 
patients. [Attrition calculation: (43/0.85)] 
o This study met challenges with personnel shifts within 
Hatton Institute that impacted data collection.  Following 
review, hiring of new staff and re-training, we determined 
to perform an interim analysis.  Of the 52 subjects enrolled 
since restructuring, 42 have completed follow-up. This 
interim analysis reveals a true attrition rate of 20%; five 
percent higher than the original 15% used in the power 
calculation. Assuming this loss rate remains constant 
through the close of the study, in order to reach 
significance, we will need to enroll an additional 27 
subjects above the planned 102.  For sake of 
randomization, we have set new total enrollment to 132.  
 Subjects will be randomized by using a random numbers table and sealed 
sequential envelopes prepared by an independent statistician.  
 
 Data Collection 
o Primary outcome: 
 VAS scores for pain “right now” and “most intense pain” [0-100mm], 
administered following breakfast on post-operative day one, comparing 
intervention and control groups 
o Secondary Outcomes: 
 VAS pain scores prior to discharge based on the validated SPS pain 
questions25. 
 VAS for satisfaction with their hospital stay prior to discharge 
 Nursing recording pain scores prior to delivery of pain medications 
(recorded in Epic) 
 Total morphine equivalents during hospital stay 

Postoperative Environment 9 
 Patient reported impression of the music and art using Likert scales, at 
discharge and 2 weeks post operatively for the intervention group 
 Patient impression of the hospital based on responses from modified 
HCAHPS questions prior to discharge on post-operative day one: 
 First Question in VAS format: “Compared to other hospitals, how 
would you rate this hospital”? 
 Second Question in VAS format: “How likely are you to 
recommend this hospital to family and friends?” 
 Patient VAS scores concerning their perception of the healing 
environment of the hospital and whether they would choose the hospital 
again 
 Responses at the 2 week postoperative appointment to another identical 
series of VAS for satisfaction and pain, questions 21 and 22 from the 
HCAHPS survey, a question on pelvic symptoms after surgery, and the 
validated Decision Regret Scale for pelvic floor disorders24 
o General Demographic Data 
 Age, BMI, race, history of depression, home medications, sexual activity, 
alcohol use, prolapse stage, procedures performed, voiding trial results, 
length of stay, surgical and postoperative complications, and estimated 
blood loss 
 
o VAS  Score Validity: 
 The VAS score is a well-established tool for measuring a patient’s pain 
level that has been in clinical practice for decades.  This tool has been 
applied throughout the medical field as a standardized measure of pain and 
remains a common method of characterizing pain levels by researchers.  It 
has been shown to be reliable in the assessment of acute pain18. 
 
o HCAHPS survey questions: 
 Survey is the first national, standardized, publicly reported survey of 
patients' perspectives of hospital care. HCAHPS (pronounced “H-caps”), 

Postoperative Environment 10 
also known as the CAHPS® Hospital Survey, is a 32- item survey 
instrument and data collection methodology for measuring patients’ 
perceptions of their hospital experience.  Beginning in 2002, CMS 
partnered with the Agency for Healthcare Research and Quality (AHRQ), 
another agency in the federal Department of Health and Human Services, 
to develop and test the HCAHPS Survey. AHRQ and its CAHPS 
Consortium carried out a rigorous and multi-faceted scientific process, 
including a public call for measures; literature review; cognitive 
interviews; consumer focus groups; stakeholder input; a three-state pilot 
test; extensive psychometric analyses; consumer testing; and numerous 
small-scale field tests. CMS provided three opportunities for the public to 
comment on HCAHPS and responded to over a thousand comments. The 
survey, its methodology and the results it produces are in the public 
domain19. 
 HCAHPS question 21: “Using any number from 0-10, where 0 is the 
worst hospital possible, and 10 is the best hospital possible, what number 
would you use to rate this hospital during your stay?” 
 HCAPS question 22: “Would you recommend this hospital to your friends 
and family?”  
 Definitely No 
 Probably no 
 Probably yes 
 Definitely yes 
 
o Data Collection tool 
 
 Intervention or experimental aspect of the study 
o Music 
 The patients will have access to a blue tooth capable audio device in their 
hospital rooms that can connect to their own device or one that will be 
provide for them. Selections of music and relaxation sounds will be 

Postoperative Environment 11 
available and they will be shown how to use the device during post-
operative rounds.   
 Music selections will generally maintain a relaxing tempo of 60-80bpm.  
 Subjects will have no limit to the amount of music they can listen to, 
however they will be asked to spend 30 minutes upon arrival to their 
room, when getting up to the chair for the first time, and following their 
voiding trial.   At a minimum, the audio device will be turned on for the 
patient during post-operative rounds, and during morning rounds if they 
have not yet done so.  
o Landscape 
 Patients will have a large print of a soothing nature landscape hung on the 
wall near the foot of their bed.  The size will approximate 24x36 inches. 
Each subject will have one scene in their room.   
 The scenes will be hung to the wall with a removable hanger. 
 Scenes were selected based on the preferences of individual surveys 
carried out with 86 volunteers.    
 
 Statistical Analysis 
o Descriptive statistics will be calculated for all continuous and categorical data. 
Continuous variables will be summarized as mean (SD) or median (range). 
Categorical variables will be presented as frequency (Percentage). The primary 
outcome is the VAS scores for pain in the morning of post-op Day 1 (POD 1). 
Student’s t-test or Mann-Whitney U test (Wilcoxon Rank Sum test) will be 
implemented to test for significant difference in pain and satisfaction scores and 
narcotic use between intervention and control groups. Assumptions will be 
examined and appropriate parametric or non-parametric tests will be used.  For 
categorical data, Chi-square or Fisher’s exact test will be employed to test the 
association.   
 
Ethical Considerations 
 Informed consent  

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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 participant confidentiality and 
prevent unauthorized release of personal information. Electronic study 
documents will be stored on a secure drive and hard copy documents stored in 
a locked area.  Thereby, all identifying and protected health information, 
including name and date of birth, will be maintained in a secure area at all 
times, accessible by authorized personnel only.  
o 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.  
o Study documentation, both electronic and hard copy will be stored securely 
for ten years and then destroyed.  
 
 When and how will results be disseminated? 
 
o We plan for the results to be disseminated in Spring 2020 at a national meeting 
in the form of a poster or oral presentation. We also plan for the results to be 
published. 
 
 
 
 
 
 
 
 

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