Music Therapy Versus Control for Total Knee Arthroplasty
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/6/2019 |
| Start Date: | October 8, 2018 |
| End Date: | December 1, 2020 |
| Contact: | Adam Sturdivant, MPH |
| Email: | adamsturdivant@uabmc.edu |
| Phone: | 205-934-4042 |
Music Therapy Versus Control During Total Knee Replacement Under Spinal Anesthesia
For millennia, people have listened to and enjoyed music for entertainment, as a distraction
from daily troubles, and as a means to relax and relieve stress. It is no real surprise that
the relaxing and stress-relieving effects of music have been shown in patients having
surgery. For patients having surgery with spinal anesthesia, music therapy during the
operation decreases sedation requirements, anxiety and may improve patient satisfaction.
Music therapy during surgery may also lead to a decreased stress response, as evidenced by
more stable cortisol levels. Studies done previously have included patients undergoing
various surgical procedures, however no studies have been done specifically for patients
undergoing total knee arthroplasty. Because total knee arthroplasty is a common procedure
usually done under spinal anesthesia at our institution, we would like to study the effects
music therapy could have on our patient population.
from daily troubles, and as a means to relax and relieve stress. It is no real surprise that
the relaxing and stress-relieving effects of music have been shown in patients having
surgery. For patients having surgery with spinal anesthesia, music therapy during the
operation decreases sedation requirements, anxiety and may improve patient satisfaction.
Music therapy during surgery may also lead to a decreased stress response, as evidenced by
more stable cortisol levels. Studies done previously have included patients undergoing
various surgical procedures, however no studies have been done specifically for patients
undergoing total knee arthroplasty. Because total knee arthroplasty is a common procedure
usually done under spinal anesthesia at our institution, we would like to study the effects
music therapy could have on our patient population.
A. Patients who consent to the study will be randomized 1:1 to either the investigational
group ("Music Therapy" group) or the control group ("No Music" group). Participants will be
randomized using a random number generator.
B. Consent and study enrollment will occur in the preoperative area prior to surgery. After
enrollment, all patients will complete a State-Trait Anxiety Assessment. Patients in the
"Music Therapy" group will be asked to choose a genre of calming music that they would like
to listen to during the operation (instrumental, jazz, classical). All patients enrolled in
the study will continue to receive routine preoperative care but will also have a baseline
cortisol level drawn. This blood draw will be compared to a cortisol level at the end of
surgery to assess the patient's physiologic stress response to surgery.
a. After proceeding to the operating room, all patients will receive routine preoperative
care during placement of spinal anesthesia. In addition to monitors routinely placed prior to
spinal block, a Bi-Spectral Index monitor will be placed on the patient's forehead to monitor
sedation levels during the procedure. A Bi-Spectral Index monitor is a noninvasive series of
patches placed on the patient's forehead that, through a propriety equation creates a number
(1-100) from processed electroencephalography waves that correlates with depth of sedation or
anesthesia. After the spinal anesthetic block is placed, the patients in the "Music Therapy"
group will wear headphones that will play their pre-selected music. The "No Music" group will
receive intraoperative standard of care with no headphones. Headphones will be worn by the
"Music Therapy" patients until the procedure is finished (skin incision is closed).
C. During the procedure, routine intraoperative sedation consisting of propofol, fentanyl and
midazolam will be administered. All patients will be given 1 mg midazolam, 50 mcg fentanyl
and propofol dosing titrated to maintain a Bi-Spectral Index level <70, which correlates to
moderate sedation.9
D. At the end of the surgical procedure (within 30 minutes of incision closure), a serum
cortisol level will be drawn to assess the physiologic stress response to surgery.
E. All patients will receive standard postoperative care in the post-anesthesia care.
F. On postoperative day 1, all patients will again complete a State-Trait Anxiety Assessment.
Additionally, they will complete a satisfaction survey.
group ("Music Therapy" group) or the control group ("No Music" group). Participants will be
randomized using a random number generator.
B. Consent and study enrollment will occur in the preoperative area prior to surgery. After
enrollment, all patients will complete a State-Trait Anxiety Assessment. Patients in the
"Music Therapy" group will be asked to choose a genre of calming music that they would like
to listen to during the operation (instrumental, jazz, classical). All patients enrolled in
the study will continue to receive routine preoperative care but will also have a baseline
cortisol level drawn. This blood draw will be compared to a cortisol level at the end of
surgery to assess the patient's physiologic stress response to surgery.
a. After proceeding to the operating room, all patients will receive routine preoperative
care during placement of spinal anesthesia. In addition to monitors routinely placed prior to
spinal block, a Bi-Spectral Index monitor will be placed on the patient's forehead to monitor
sedation levels during the procedure. A Bi-Spectral Index monitor is a noninvasive series of
patches placed on the patient's forehead that, through a propriety equation creates a number
(1-100) from processed electroencephalography waves that correlates with depth of sedation or
anesthesia. After the spinal anesthetic block is placed, the patients in the "Music Therapy"
group will wear headphones that will play their pre-selected music. The "No Music" group will
receive intraoperative standard of care with no headphones. Headphones will be worn by the
"Music Therapy" patients until the procedure is finished (skin incision is closed).
C. During the procedure, routine intraoperative sedation consisting of propofol, fentanyl and
midazolam will be administered. All patients will be given 1 mg midazolam, 50 mcg fentanyl
and propofol dosing titrated to maintain a Bi-Spectral Index level <70, which correlates to
moderate sedation.9
D. At the end of the surgical procedure (within 30 minutes of incision closure), a serum
cortisol level will be drawn to assess the physiologic stress response to surgery.
E. All patients will receive standard postoperative care in the post-anesthesia care.
F. On postoperative day 1, all patients will again complete a State-Trait Anxiety Assessment.
Additionally, they will complete a satisfaction survey.
Inclusion Criteria:
- Patients undergoing total knee arthroplasty under spinal anesthesia.
- Patients 18 years of age or older.
- Patients classified by the American Society of Anesthesiology (ASA) class I, II, or
III.
Exclusion Criteria:
- Any patient not classified as an ASA I, II, or III.
- Patients with hearing impairment, defined by personal endorsement of hearing
impairment or use of hearing aids.
- Patients with contraindication to spinal anesthesia.
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