Music Therapy Versus Control for Total Knee Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Music Therapy Versus Control During Total Knee Replacement Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03569397
• Other study ID #: 56789012
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: November 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, patients in the music therapy group will complete a satisfaction survey.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 10, 2020
• Est. primary completion date: December 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Other:
• Music Therapy
Patients will be administered music therapy during the operation.

Locations

Country	Name	City	State
United States	UAB Highlands Hospital	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	On a scale of 1-5 (Likert scale) patients were asked to rank their satisfaction with their perioperative care. 1 indicates poor satisfaction, 5 indicates excellent satisfaction. Only patients in the music therapy group were asked for their satisfaction ranking.	Postoperative day 1