Music Therapy Versus Control for Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03569397|
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Knee||Other: Music Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Music Therapy Versus Control During Total Knee Replacement Under Spinal Anesthesia|
|Actual Study Start Date :||October 8, 2018|
|Actual Primary Completion Date :||December 18, 2019|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: Music Therapy
Administer music therapy during the operation
Other: Music Therapy
For patients having surgery with spinal anesthesia, administration of 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.
No Intervention: Non-Music Therapy
No headphones or music therapy during the operation
- Patient Satisfaction [ Time Frame: Postoperative day 1 ]Patient completing State-Trait Anxiety Assessment Questionnaire, Satisfaction Survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569397
|United States, Alabama|
|UAB Highlands Hospital|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Promil Kukreja, MD, PhD||UAB Department of Anesthesiology|