Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery
Phase: NA
Conditions: Anesthesia; Functional, Surgery
Sponsor: Virginia Commonwealth University

Study ID: HM20010566 
COVER PAGE 
 
Title of study:  Music distraction and its influence on anesthetic requirements 
during elective knee surgery 
NCT number: not yet assigned 
Date of document: March 26, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study ID: HM20010566 
 
Research investigators:  Bryant Tran, Gregory Golladay, Sabrina Dhillon, Maliha Nowrouz, Kathryn 
Breslin 
 
Hypothesis: music distraction can be used to reduce or eliminate anesthetic requirements when total 
knee replacement is performed under spinal anesthesia. 
 
Specific aims of the study: 
 
To use music in a way that distracts participants without distracting other health care workers in 
the operating room 
 
To use music in a way that does not disrupt the workflow of the anesthesia team or affect their 
ability to monitor the participant and administer medications safely 
 
To determine if the music can be used to reduce anesthetic requirements when total knee 
replacement is performed under spinal anesthesia 
 
Background: 
Music during surgical procedures has been shown to have a number of desirable effects. A review of the 
literature reveals the following: 
 
Patients have decreased anxiety, heart rate and blood pressure when music is played for them 
before and during awake craniotomy(1). 
 
Patients have decreased pain scores and increased satisfaction when they listen to music under 
general anesthesia(2). 
 
Burn patients who listen to music during treatment procedures have decreased anxiety and 
heart rate(3). 
 
Surgeons have decreased anxiety when music is played in the procedural suite during cutaneous 
dermatologic procedures(4). 
 
Patients have decreased sufentanil opioid requirement when music is played before and after 
lung resection surgery(5). 
To date, there are no studies that assess music and its effect on anesthetic requirements during major 
elective orthopedic surgery.  Spinal anesthesia allows knee and hip surgery to be performed without 
putting a patient completely to sleep.  However, some anesthesia medications are often required as a 
standard of care to provide patient comfort and reduce patient anxiety.  Risks are associated with the 
use of anesthetic medications, even if the medications are used only for sedation and comfort. These 
risks include respiratory depression or aspiration of gastric content into the lungs.  Occasionally, the 
aforementioned outcomes result in hospital admission to the intensive care unit.  This study has 
significance because it seeks to explore a non-pharmacologic modality that could ultimately decrease 
the incidence of complications associated with anesthesia. 

Study ID: HM20010566 
 
Methods: 
This prospective study will assess music and its ability to influence anesthetic requirements in patients 
receiving primary elective knee replacement surgery.  All research participants will undergo the same 
surgical procedure by the same surgeon, who is one of the research investigators (Dr. Gregory Golladay).  
 
Potential participants will be recruited during any of three pre-operative encounters that are considered 
standard to our institution: 1) the surgery clinic visit, 2) the pre-operative anesthesia clinic visit, or 3) the 
pre-operative surgical unit on the day of surgery.  Formal consent will be obtained in the pre-operative 
surgical unit on the day of surgery. 
 
Prior to surgery, patient participants will receive a combined spinal-epidural per VCU total joint 
protocol; the following steps are considered standard of care and not considered study procedures. The 
combined spinal-epidural procedure creates complete numbness below the abdomen down to the feet, 
which negates the need for general anesthesia. For patient comfort during the combined-spinal epidural 
procedure, a one-time dose of 2 milligrams of intravenous midazolam will be given; this dose is 
adequate for reducing anxiety while allowing the patient to maintain conversation with health care 
providers if necessary. The standard intrathecal dose for total knee replacement at our institution is 15 
mg bupivacaine and 0.2 mg preservative-free morphine; this dose will provide complete numbness to 
the lower extremities for approximately 3-6 hours. After this dose is administered, the patient will then 
be positioned appropriately in the operating room and vital signs will monitored per standard protocol.  
 
Each patient participant will be randomized to one of two groups. Participants in the control group will 
receive noise-cancelling wireless headphones that will not play any noise throughout the procedure. 
Participants in the experimental group will receive the same noise-cancelling wireless headphones but 
will be permitted to listen to the music of their choice while in the operating room. Music will be 
provided via Spotify, which is an Internet streaming music service, and will be played through 
headphones; this way, no other individual in the operating room will be distracted or influenced by the 
patient's music selection. Participants will not be able to change the Spotify channel. We will be using 
the paid Spotify service with no commercials. If participants opt to have the music stopped, we will 
withdraw them from the study and continue standard of care. The participants will have the music 
playing for about two hours. If the participant has no music preference, the music will be chosen for 
them and it will be the same for all participants that have no preference. The volume will be adjusted in 
the operating room until the participant approves of the volume by saying "yes, the volume is good" or 
giving another verbal cue of approval.  The music will continue playing until the surgical procedure is 
complete and the patient has reached the post-anesthesia recovery unit. 
 
As stated previously, spinal anesthesia provides numbness that negates the need for general anesthesia, 
but patients often times need additional sedation, which will be defined as anesthesia medication that is 

Study ID: HM20010566 
used to treat patient anxiety and discomfort in the operating room. Patient participants in both groups 
will receive sedation via the same protocol, which is outlined below. 
 
It is important to note that the standard of care for this procedure involves the administration of 
sedation that is given at the anesthesiologist's discretion; sedation is generally given when the patient 
exhibits signs of discomfort or anxiety. The protocol described below is designed specifically for this 
study in order to provide standardization within the study participants; the protocol instructions fall 
within the standard of care for the administration of sedation by an anesthesia provider. 
 
Sedation will only be given as needed per patient request; the patient will be given a noise-making 
device (such as a rubber duckie that makes sound when squeezed) that will inform the anesthesia 
provider that the patient is uncomfortable and needs some sedation. A weight based dose of 0.3 
micrograms per kilogram of intravenous propofol will be given for each patient request. This dose is 
expected to provide amnesia or light sleep for a few minutes. For patient safety, if the patient requests 
sedation more than once within a two minute window, the anesthesia provider will not administer any 
more medication during this two minute period. Additionally, the anesthesia provider may withhold 
sedation if he or she determines with physical exam and hemodynamic monitors that the patient is 
already over-sedated. 
 
After five propofol boluses have been given to a patient, a propofol continuous infusion will be initiated 
at 25mcg/kg/min. The patient may still request additional sedation with the request instrument if he or 
she is still conscious enough to do so. If the anesthesia provider has given more than five boluses even 
with the baseline propofol infusion, the infusion will be increased to 50mcg/kg/min. In the highly 
unlikely scenario that five additional boluses are required with a propofol infusion rate of 50 
mcg/kg/min, the anesthesia providers and investigators will make a clinical decision as to what is the 
safest next step. 
 
There may be scenarios that warrant conversion to general anesthesia. These scenarios include, but are 
not limited to, hemodynamic instability, regurgitation of gastric content, obtundation, excessive 
agitation, and inadequate spinal anesthesia. The decision to convert to the general anesthesia will be 
made by the anesthesiologist and anesthesia provider in the operating room; implementation of this 
study should not prevent or delay this decision if it is necessary. 
 
Documentation will be completed by the anesthesia provider per standard protocol for electronic 
anesthesia charting at VCU. This will allow for data acquisition by the investigators through the 
anesthesiology printed record in Cerner. The primary outcome for this study will be the amount of 
sedation required during the surgical procedure; this will be calculated into micrograms of propofol per 
kilogram per minute. For this study, propofol will be used during the surgical procedure and intravenous 
midazolam and intrathecal morphine will be used for the spinal procedure; no other sedating 

Study ID: HM20010566 
medications will be used. The secondary outcomes for this study will include pain scores and patient 
satisfaction at determined time intervals before and after the surgery. 
 
Primary data elements that will be obtained are as follows: 1) the total amount of propofol given, 2) the 
duration of operating room time, which will be defined as "in the operating room" time to "out of the 
operating room" time. Data will be entered into a spreadsheet; the amount of propofol per unit of time 
will be calculated by dividing #2 from #1; if there is a difference and it is statistically significant, then our 
hypothesis is true. 
 
Secondary data elements will include numerical pain scores, which are taken via standard of care 
nursing assessment immediately after surgery and every four hours afterwards; the study will collect the 
numerical pain scores that describe each four hour interval for a 24 hour time period. The numerical 
pain scores will be collected through the patient's medical record after the 24 hour time period has 
passed. Data will placed into a spreadsheet and a statistical analysis will be performed for each time 
interval. This will answer the question of whether or not post-operative pain scores are affected the 
music intervention. 
 
Another secondary data element will include patient satisfaction, which will be determined through a 
hospital survey that is completed by the patient and is standard of care. The data points will focus on 
two patient satisfaction questions on the survey, which ask "did you feel like your pain was controlled" 
and "did you feel like the doctors did everything that could to control your pain." These are yes/no 
questions, and data can be collected and presented as the percentage of participants that answered 
"yes" to these questions. As standard of care, the surveys are completed when the patient is discharged 
from the hospital, the survey data is scanned into the electronic medical record; therefore, this data will 
need to be collected in the medical record after the participant has completed their hospital stay. This 
will answer the question of whether or not the music intervention affects patient satisfaction with 
respect to pain management, which is the area of interest for the study team. 
 
 
 
 
 
 
 
 
 

Study ID: HM20010566 
References 
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Jun;32:56-60. 
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therapy under general anesthesia in patients undergoing abdominal surgery. Libyan J Med. 2017 
Dec;12(1). 
3. Li J1, Zhou L2, Wang Y3. The effects of music intervention on burn patients during treatment 
procedures: a systematic review and meta-analysis of randomized controlled trials. BMC Complement 
Altern Med. 2017 Mar 17;17(1):158. 
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Polavarapu M, Yoo S. Utility of recorded guided imagery and relaxing music in reducing patient pain and 
anxiety, and surgeon anxiety, during cutaneous surgical procedures: A single-blinded randomized 
controlled trial. J Am Acad Dermatol. 2016 Sep;75(3):585-589.  
5. Wang Y1,2, Tang H3, Guo Q1, Liu J4, Liu X3, Luo J5, Yang W4. Effects of Intravenous Patient-Controlled 
Sufentanil Analgesia and Music Therapy on Pain and Hemodynamics After Surgery for Lung Cancer: A 
Randomized Parallel Study. J Altern Complement Med. 2015 Nov;21(11):667-72.