NCT02039271

Brief Summary

The aim of the present study is to determine if the use of music as an intervention can be utilized, in conjunction with normal pharmacological treatment, in decreasing pain and increasing patient satisfaction, in male and female total knee replacement patients, from the age of 50 and 70, during the first 48 postoperative hours after surgery. It is the hope that this study can add to current research addressing the pain relief needs of orthopedic patients following total knee replacement surgery using music listening as an adjuvant therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

January 15, 2014

Last Update Submit

December 19, 2016

Conditions

Keywords

musictotal knee replacementPain management

Outcome Measures

Primary Outcomes (1)

  • Pain perception level reduction

    The use of music will result in a reduction of the subject's perceived pain level.

    48 hours

Secondary Outcomes (1)

  • Subject anxiety level reduction

    48 hours

Study Arms (2)

Standard of Care

NO INTERVENTION

Subjects will receive standard post-operative care after total knee replacment surgery

Music Therapy

EXPERIMENTAL

Subjects will receive music therapy in addition to standard post-operative therapy.

Other: Music therapy

Interventions

This will include 30 minutes before and after ambulation on post-op days 1 and 2. This will be contingent on when the participant had surgery the day prior and when they are ready and able to begin ambulating. Participants in the intervention group will do a VAS prior to listening to music and then afterward while those in the control group will do a VAS prior to and after each ambulation. Participants will be ambulating twice a day, in the AM and PM so the intervention will be given twice a day.

Music Therapy

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study participants will consist of a convenient sample of male and female, multicultural, adult patients between 50 and 70 years of age, without obvious hearing impairment, medically cleared, and scheduled for knee replacement surgery.

You may not qualify if:

  • Non-English speaking and/or individuals with hearing impairment will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager Nursing Research

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 17, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

October 1, 2014

Last Updated

December 20, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

no plan to share data

Locations