Arthroplasty, Replacement, KneeNCT03569397
Music Therapy Versus Control for Total Knee Arthroplasty
A study testing Music Therapy in people with Arthroplasty, Replacement, Knee, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2018to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Therapy Versus Control During Total Knee Replacement Under Spinal Anesthesia
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.
Read the detailed description
- 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.
- 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.
- 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).
- 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
- 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.
- All patients will receive standard postoperative care in the post-anesthesia care.
- 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.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Music Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
Patients will be administered music therapy during the operation.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy | Experimental | Administer music therapy during the operation Receives: Other: Music Therapy |
| Non-Music Therapy | No intervention | No headphones or music therapy during the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start8 Oct 2018
- Primary completion18 Dec 2019
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Promil Kukreja, University of Alabama at Birmingham
- Investigators
- Promil Kukreja, MD, PhD, Principal investigator, UAB Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569397
- Sponsor's protocol ID
- 56789012
- Status last verified
- Nov 2020
- First submitted
- 15 Jun 2018
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32337122
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy Versus Control During Total Knee Replacement Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03569397
- Acronym / sponsor ID
- 56789012
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 18 Dec 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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).
- 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
- 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.
- All patients will receive standard postoperative care in the post-anesthesia care.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Therapy | Experimental | Other: Music TherapyAdminister music therapy during the operation |
| Non-Music Therapy | No intervention | –No headphones or music therapy during the operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 TherapyPatients will be administered music therapy during the operation. | Other | Music Therapy |
Primary outcome
Patient Satisfaction
Time frame: Postoperative day 1
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32337122Kukreja 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.
- Individual participant dataSharing planned: Undecided
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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.
Promil Kukreja, MD, PhD principal investigator
UAB Department of Anesthesiology
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 Arthroplasty, Replacement, Knee, run by University of Alabama at Birmingham 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 3 inclusion and 3 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 5 May 2021. 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?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Satisfaction (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569397, which also lists 1 linked publication.
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 5 May 2021.