Adjunctive Music Therapy in Total Knee ReplacementNCT02039271
Effects of Music Listening on Pain and Patient Satisfaction Within First 48 Hours After Knee Replacment Surgery
A study testing Music therapy in people with Adjunctive Music Therapy in Total Knee Replacement, run by Loma Linda University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Adjunctive Music Therapy in Total Knee Replacement
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non-English speaking and/or individuals with hearing impairment will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: Effects of Music Listening on Pain and Patient Satisfaction Within First 48 Hours of Knee Replacement Surgery
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.
Read the detailed description
Each participant will be randomized into two different groups: the intervention group that will receive music listening along with the standard of care, or the control group, which will receive the standard of care only. Each individual will ambulate twice daily after surgery, and the intervention group will listen to music, with an MP3 player, for 30 minutes before and after each ambulation. Both groups will fill out a Visual Analog Scale (VAS) for pain before and after ambulation, and at the end of the study participants in the intervention group will fill out a 9-item questionnaire to determine patient satisfaction from music listening. Each subject will be assigned an ID#, and asked what type of music they would like to listen to if assigned to the intervention group.
Randomization will be done using a random table of numbers with enough numbers to randomize the ten participants and any individuals that may decide to withdraw from the study. If the participant will be included in the intervention group then the MP3 player will be shown to the participant and instruction given on proper usage. A laminated card with instructions will be included to reinforce instruction. The MP3 player, along with the instructions and VAS forms, will be kept in a colored clipboard by the participant's bedside, easily accessible for listening and documentation. If the participant is not in the study they will be told that they will still be receiving the standard of care, and it will be important to be in study either way so that the information between groups can be compared. Each participant in the study will be told whether they will be in the intervention or control group in the pre-op holding area day of surgery. Those in the intervention group will then be instructed in the proper use of the MP3 player and how to fill out the VAS for pain form. This instruction will be repeated again prior to the patient's first ambulation on post-op day one.
The intervention group will receive music for 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. Both groups will receive the standard of care for pain control, which will be established by the surgeon and implemented by nursing. Finally, the patient satisfaction questionnaire will be given to participants in the intervention group to be filled out prior to discharge.
Nursing and physical therapy will be educated on the research process, intervention, and related forms. This will include the proper way of turning the device on and off, how to adjust the volume, ways of choosing different types of music from the various playlists available, and how to charge or change the batteries. Instruction will be given in when and for how long the device should be used. In addition, nursing will be educated on proper use of the VAS form and patient satisfaction questionnaire.
The intervention is estimated to take two and a half hours, over the first two post operative days, for setting up, listening to, and break down of the MP3 player, as well as 30 minutes to fill out two VAS forms and the patient satisfaction form, for a total of three hours. For those participants in the control group, total time will be approximately 30 minutes to fill out the two VAS forms over the same time period. The staff researcher will be available during this time period to aid in proper use of the MP3 player and in filling out the VAS and patient satisfaction forms so as to minimize time nursing and physical therapy would otherwise need to be involved with the intervention and filling out of forms.
- Being tested
- Music therapy
- Keywords
- music, total knee replacement, Pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Music therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception level reduction
The use of music will result in a reduction of the subject's perceived pain level.
Measured: 48 hours
Secondary outcomes (1)
Subject anxiety level reduction
The use of music will result in a reduction in subject levels of anxeity
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjunctive Music Therapy in Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patti Radovich, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039271
- Sponsor's protocol ID
- 5130342
- Other IDs
- 5130342
- Status last verified
- Dec 2016
- First submitted
- 15 Jan 2014
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music Listening on Pain and Patient Satisfaction Within First 48 Hours of Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT02039271
- Acronym / sponsor ID
- 5130342
- Keywords
- music, total knee replacement, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each participant will be randomized into two different groups: the intervention group that will receive music listening along with the standard of care, or the control group, which will receive the standard of care only. Each individual will ambulate twice daily after surgery, and the intervention group will listen to music, with an MP3 player, for 30 minutes before and after each ambulation. Both groups will fill out a Visual Analog Scale (VAS) for pain before and after ambulation, and at the end of the study participants in the intervention group will fill out a 9-item questionnaire to determine patient satisfaction from music listening. Each subject will be assigned an ID#, and asked what type of music they would like to listen to if assigned to the intervention group.
Randomization will be done using a random table of numbers with enough numbers to randomize the ten participants and any individuals that may decide to withdraw from the study. If the participant will be included in the intervention group then the MP3 player will be shown to the participant and instruction given on proper usage. A laminated card with instructions will be included to reinforce instruction. The MP3 player, along with the instructions and VAS forms, will be kept in a colored clipboard by the participant's bedside, easily accessible for listening and documentation. If the participant is not in the study they will be told that they will still be receiving the standard of care, and it will be important to be in study either way so that the information between groups can be compared. Each participant in the study will be told whether they will be in the intervention or control group in the pre-op holding area day of surgery. Those in the intervention group will then be instructed in the proper use of the MP3 player and how to fill out the VAS for pain form. This instruction will be repeated again prior to the patient's first ambulation on post-op day one.
The intervention group will receive music for 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. Both groups will receive the standard of care for pain control, which will be established by the surgeon and implemented by nursing. Finally, the patient satisfaction questionnaire will be given to participants in the intervention group to be filled out prior to discharge.
Nursing and physical therapy will be educated on the research process, intervention, and related forms. This will include the proper way of turning the device on and off, how to adjust the volume, ways of choosing different types of music from the various playlists available, and how to charge or change the batteries. Instruction will be given in when and for how long the device should be used. In addition, nursing will be educated on proper use of the VAS form and patient satisfaction questionnaire.
The intervention is estimated to take two and a half hours, over the first two post operative days, for setting up, listening to, and break down of the MP3 player, as well as 30 minutes to fill out two VAS forms and the patient satisfaction form, for a total of three hours. For those participants in the control group, total time will be approximately 30 minutes to fill out the two VAS forms over the same time period. The staff researcher will be available during this time period to aid in proper use of the MP3 player and in filling out the VAS and patient satisfaction forms so as to minimize time nursing and physical therapy would otherwise need to be involved with the intervention and filling out of forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Subjects will receive standard post-operative care after total knee replacment surgery |
| Music Therapy | Experimental | Other: Music therapySubjects will receive music therapy in addition to standard post-operative therapy. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Non-English speaking and/or individuals with hearing impairment will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyThis 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. | Other | Music Therapy |
Primary outcome
Pain perception level reduction
Time frame: 48 hours
The use of music will result in a reduction of the subject's perceived pain level.
1 secondary outcome
Subject anxiety level reduction
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Individual participant dataSharing planned: No. no plan to share data
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Adjunctive Music Therapy in Total Knee Replacement, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception level reduction (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.