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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
Sponsor:
Information provided by (Responsible Party):
Promil Kukreja, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE June 15, 2018
First Posted Date  ICMJE June 26, 2018
Last Update Posted Date January 18, 2020
Actual Study Start Date  ICMJE October 8, 2018
Actual Primary Completion Date December 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
Patient Satisfaction [ Time Frame: Postoperative day 1 ]
Patient completing State-Trait Anxiety Assessment Questionnaire, Satisfaction Survey
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Music Therapy Versus Control for Total Knee Arthroplasty
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Arthroplasty, Replacement, Knee
Intervention  ICMJE 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 14, 2020)
57
Original Estimated Enrollment  ICMJE
 (submitted: June 15, 2018)
100
Estimated Study Completion Date  ICMJE December 1, 2020
Actual Primary Completion Date December 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03569397
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Promil Kukreja, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Promil Kukreja, MD, PhD UAB Department of Anesthesiology
PRS Account University of Alabama at Birmingham
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP