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Music Therapy Versus Control for Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03569397
Recruitment Status : Completed
First Posted : June 26, 2018
Results First Posted : May 5, 2021
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Promil Kukreja, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Arthroplasty, Replacement, Knee
Intervention Other: Music Therapy
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Music Therapy Non-Music Therapy
Hide Arm/Group Description Patients will be administered music therapy during the operation. No headphones or music therapy during the operation
Period Title: Overall Study
Started 29 28
Completed 29 28
Not Completed 0 0
Arm/Group Title Music Therapy Non-Music Therapy Total
Hide Arm/Group Description Patients will be administered music therapy during the operation. No headphones or music therapy during the operation Total of all reporting groups
Overall Number of Baseline Participants 29 28 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 28 participants 57 participants
65.14  (1.82) 61.68  (2.27) 62.3  (1.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 57 participants
Female
20
  69.0%
18
  64.3%
38
  66.7%
Male
9
  31.0%
10
  35.7%
19
  33.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants 28 participants 57 participants
29
 100.0%
28
 100.0%
57
 100.0%
1.Primary Outcome
Title Patient Satisfaction
Hide Description 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.
Time Frame Postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Music Therapy
Hide Arm/Group Description:
Patients will be administered music therapy during the operation.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: score on a scale
4.48  (0.16)
Time Frame From the time of discharge to 12 months post discharge
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Music Therapy Non-Music Therapy
Hide Arm/Group Description Patients will be administered music therapy during the operation. No headphones or music therapy during the operation
All-Cause Mortality
Music Therapy Non-Music Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/28 (0.00%) 
Hide Serious Adverse Events
Music Therapy Non-Music Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/28 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Music Therapy Non-Music Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adam Sturdivant, MPH
Organization: University of Alabama at Birmingham
Phone: 205-934-4042
EMail: Adamsturdivant@uabmc.edu
Layout table for additonal information
Responsible Party: Promil Kukreja, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03569397    
Other Study ID Numbers: 56789012
First Submitted: June 15, 2018
First Posted: June 26, 2018
Results First Submitted: November 30, 2020
Results First Posted: May 5, 2021
Last Update Posted: May 5, 2021