NCT03569397

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 5, 2021

Completed
Last Updated

May 5, 2021

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

June 15, 2018

Results QC Date

November 30, 2020

Last Update Submit

May 4, 2021

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Music Therapy

EXPERIMENTAL

Administer music therapy during the operation

Other: Music Therapy

Non-Music Therapy

NO INTERVENTION

No headphones or music therapy during the operation

Interventions

Music TherapyOTHER

Patients will be administered music therapy during the operation.

Music Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Highlands Hospital

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • 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.

    PMID: 32337122DERIVED

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Adam Sturdivant, MPH
Organization
University of Alabama at Birmingham
Adamsturdivant@uabmc.edu
205-934-4042

Study Officials

  • Promil Kukreja, MD, PhD

    UAB Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2018

First Posted

June 26, 2018

Study Start

October 8, 2018

Primary Completion

December 18, 2019

Study Completion

March 10, 2020

Last Updated

May 5, 2021

Results First Posted

May 5, 2021

Record last verified: 2020-11

Locations

US(1)