Music Therapy Versus Control for Total Knee Arthroplasty

• ClinicalTrials.gov Identifier: NCT03569397
• Recruitment Status: Active, not recruiting
• First Posted: June 26, 2018
• Last Update Posted: January 18, 2020
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Promil Kukreja, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: June 15, 2018
• First Posted Date: June 26, 2018
• Last Update Posted Date: January 18, 2020
• Actual Study Start Date: October 8, 2018
• Actual Primary Completion Date: December 18, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 15, 2018)

Patient Satisfaction [ Time Frame: Postoperative day 1 ]

Patient completing State-Trait Anxiety Assessment Questionnaire, Satisfaction Survey

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Music Therapy Versus Control for Total Knee Arthroplasty
• Official Title: Music Therapy Versus Control During Total Knee Replacement Under Spinal Anesthesia
• 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.

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Arthroplasty, Replacement, Knee

Intervention

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.

Study Arms

• Experimental: Music Therapy
  Administer music therapy during the operation
  Intervention: Other: Music Therapy
• No Intervention: Non-Music Therapy
  No headphones or music therapy during the operation

• Publications *: Kukreja P, Talbott K, MacBeth L, Ghanem E, Sturdivant AB, Woods A, Potter WA, Kalagara H. Effects of Music Therapy During Total Knee Arthroplasty Under Spinal Anesthesia: A Prospective Randomized Controlled Study. Cureus. 2020 Mar 24;12(3):e7396. doi: 10.7759/cureus.7396.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 14, 2020): 57
• Original Estimated Enrollment (submitted: June 15, 2018): 100
• Estimated Study Completion Date: December 1, 2020
• Actual Primary Completion Date: December 18, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03569397
• Other Study ID Numbers: 56789012
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Promil Kukreja, University of Alabama at Birmingham
• Study Sponsor: University of Alabama at Birmingham
• Collaborators: Not Provided

Investigators

• Principal Investigator: Promil Kukreja, MD, PhD; UAB Department of Anesthesiology

• PRS Account: University of Alabama at Birmingham
• Verification Date: September 2019