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Music Therapy Versus Control for Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569397
Recruitment Status : Active, not recruiting
First Posted : June 26, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Promil Kukreja, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Other: Music Therapy Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: Postoperative day 1 ]
    Patient completing State-Trait Anxiety Assessment Questionnaire, Satisfaction Survey



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Alabama
UAB Highlands Hospital
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Promil Kukreja, MD, PhD UAB Department of Anesthesiology

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Responsible Party: Promil Kukreja, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03569397    
Other Study ID Numbers: 56789012
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No