Anesthesia; FunctionalNCT03486106
Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery
A study testing Music, Headphones and Propofol in people with Anesthesia; Functional and Surgery, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This study evaluates the effect of music and its influence on anesthetic requirements during total knee replacement surgery. Half of the participants will receive noise-cancelling headphones in the operating room, and the other half of participants will receive noise-cancelling headphones with music playing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia; Functional, Surgery
- What is being tested?
- Music, Headphones and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2018to 15 Jul 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing a primary elective total knee replacement by Dr. Gregory Golladay (VCU surgeon and co-investigator for this research study)
- 18 years of age or older
- eligible for spinal anesthesia (which will be determined by the health care providers during the standard pre-surgery clinic visits)
- mentally capable of understanding instructions on how to request anesthesia medication
- mentally capable of understanding instructions on how to rate pain scores, anxiety level, and patient satisfaction
Who cannot join
- identified as a member of a regulated vulnerable population (one exception: limited English proficiency does not preclude them from this study; translation documents are available)
- ineligibility for spinal anesthesia (which will be determined by the health care providers during the standard pre-surgery clinic visits)
- morbid obesity, BMI greater than 40
- allergy to propofol, midazolam, or morphine
- pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours
- hearing impaired individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
This study evaluates the effect of music and its influence on anesthetic requirements during total knee replacement surgery. Half of the participants will receive noise-cancelling headphones in the operating room, and the other half of participants will receive noise-cancelling headphones with music playing.
Read the detailed description
Prior to surgery, patient participants will receive a combined spinal-epidural per VCU total joint protocol; the following steps are considered standard of care and not considered study procedures. The combined spinal-epidural procedure creates complete numbness below the abdomen down to the feet, which negates the need for general anesthesia. For patient comfort during the combined-spinal epidural procedure, a one-time dose of 2 milligrams of intravenous midazolam will be given; this dose is adequate for reducing anxiety while allowing the patient to maintain conversation with health care providers if necessary. The standard intrathecal dose for total knee replacement at our institution is 15 mg bupivacaine and 0.2 mg preservative-free morphine; this dose will provide complete numbness to the lower extremities for approximately 3-6 hours. After this dose is administered, the patient will then be positioned appropriately in the operating room and vital signs will monitored per standard protocol.
Each patient participant will be randomized to one of two groups. Participants in the control group will receive noise-cancelling wireless headphones that will not play any noise throughout the procedure. Participants in the experimental group will receive the same noise-cancelling wireless headphones but will be permitted to listen to the music of their choice while in the operating room. Music will be provided via Spotify, which is an Internet streaming music service, and will be played through headphones; this way, no other individual in the operating room will be distracted or influenced by the patient's music selection. Participants will not be able to change the Spotify channel. We will be using the paid Spotify service with no commercials. If participants opt to have the music stopped, we will withdraw them from the study and continue standard of care. The participants will have the music playing for about two hours. If the participant has no music preference, the music will be chosen for them and it will be the same for all participants that have no preference. The volume will be adjusted in the operating room until the participant approves of the volume by saying "yes, the volume is good" or giving another verbal cue of approval.The music will continue playing until the surgical procedure is complete and the patient has reached the post-anesthesia recovery unit.
As stated previously, spinal anesthesia provides numbness that negates the need for general anesthesia, but patients often times need additional sedation, which will be defined as anesthesia medication that is used to treat patient anxiety and discomfort in the operating room. Patient participants in both groups will receive sedation via the same protocol, which is outlined below.
Sedation will only be given as needed per patient request; the patient will be given a noise-making device (such as a rubber duckie that makes sound when squeezed) that will inform the anesthesia provider that the patient is uncomfortable and needs some sedation. A weight based dose of 0.3 micrograms per kilogram of intravenous propofol will be given for each patient request. This dose is expected to provide amnesia or light sleep for a few minutes. For patient safety, if the patient requests sedation more than once within a two minute window, the anesthesia provider will not administer any more medication during this two minute period. Additionally, the anesthesia provider may withhold sedation if he or she determines with physical exam and hemodynamic monitors that the patient is already over-sedated.
After five propofol boluses have been given to a patient, a propofol continuous infusion will be initiated at 25mcg/kg/min. The patient may still request additional sedation with the request instrument if he or she is still conscious enough to do so. If the anesthesia provider has given more than five boluses even with the baseline propofol infusion, the infusion will be increased to 50mcg/kg/min. In the highly unlikely scenario that five additional boluses are required with a propofol infusion rate of 50 mcg/kg/min, the anesthesia providers and investigators will make a clinical decision as to what is the safest next step.
There may be scenarios that warrant conversion to general anesthesia. These scenarios include, but are not limited to, hemodynamic instability, regurgitation of gastric content, obtundation, excessive agitation, and inadequate spinal anesthesia. The decision to convert to the general anesthesia will be made by the anesthesiologist and anesthesia provider in the operating room; implementation of this study should not prevent or delay this decision if it is necessary.
Documentation will be completed by the anesthesia provider per standard protocol for electronic anesthesia charting at VCU. This will allow for data acquisition by the investigators through the anesthesiology printed record in Cerner.
- Conditions
- Anesthesia; Functional, Surgery
- Being tested
- Music, Headphones, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Music will be provided via Spotify, which is an Internet streaming music service, and will be played through headphones; this way, no other individual in the operating room will be distracted or influenced by the patient's music selection.
HeadphonesOther
All participants will receive noise-cancelling wireless headphones that they will wear in the operating room during the procedure.
PropofolDrug
All participants will receive intravenous doses of propofol; the timing and frequency of the doses will be given when the patient indicates (by squeezing a rubber duckie) that he/she wants sedation medication.
| Study group | Role | What they receive |
|---|---|---|
| Headphones without music | Placebo comparator | Participants in the control group will receive noise-cancelling wireless headphones that will not play any noise throughout the procedure. They will also receive propofol for sedation as needed. Receives: Other: Headphones; Drug: Propofol |
| Headphones with music | Experimental | Participants in the experimental group will receive the same noise-cancelling wireless headphones but will be permitted to listen to the music of their choice while in the operating room. They will also receive propofol for sedation as needed. Receives: Other: Music; Other: Headphones; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative propofol requirement
The amount of propofol given in the operating room divided by duration of operating room time
Measured: 2 hours
Secondary outcomes (2)
Pain score
The study will collect the numerical pain scores during each four hour interval for a 24 hour time period
Measured: 24 hours
Satisfaction score
Patient satisfaction will be determined through a hospital survey that is completed by the patient at the end of their hospital stay
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start13 Jul 2018
- Primary completion12 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; FunctionalStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryant Tran, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486106
- Sponsor's protocol ID
- HM20010566
- Status last verified
- Jul 2019
- First submitted
- 20 Mar 2018
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu PY, Huang ML, Lee WP, Wang C, Shih WM. Effects of music listening on anxiety and physiological responses in patients undergoing awake craniotomy. Complement Ther Med. 2017 Jun;32:56-60. doi: 10.1016/j.ctim.2017.03.007. Epub 2017 Mar 31.
PubMed 28619305Kahloul M, Mhamdi S, Nakhli MS, Sfeyhi AN, Azzaza M, Chaouch A, Naija W. Effects of music therapy under general anesthesia in patients undergoing abdominal surgery. Libyan J Med. 2017 Dec;12(1):1260886. doi: 10.1080/19932820.2017.1260886.
PubMed 28452603Li J, Zhou L, Wang Y. The effects of music intervention on burn patients during treatment procedures: a systematic review and meta-analysis of randomized controlled trials. BMC Complement Altern Med. 2017 Mar 17;17(1):158. doi: 10.1186/s12906-017-1669-4.
PubMed 28302117Alam M, Roongpisuthipong W, Kim NA, Goyal A, Swary JH, Brindise RT, Iyengar S, Pace N, West DP, Polavarapu M, Yoo S. Utility of recorded guided imagery and relaxing music in reducing patient pain and anxiety, and surgeon anxiety, during cutaneous surgical procedures: A single-blinded randomized controlled trial. J Am Acad Dermatol. 2016 Sep;75(3):585-589. doi: 10.1016/j.jaad.2016.02.1143. Epub 2016 Apr 25.
PubMed 27125531Wang Y, Tang H, Guo Q, Liu J, Liu X, Luo J, Yang W. Effects of Intravenous Patient-Controlled Sufentanil Analgesia and Music Therapy on Pain and Hemodynamics After Surgery for Lung Cancer: A Randomized Parallel Study. J Altern Complement Med. 2015 Nov;21(11):667-72. doi: 10.1089/acm.2014.0310. Epub 2015 Sep 2.
PubMed 26331434
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Distraction and Its Influence on Anesthetic Requirements During Elective Knee Surgery
- ClinicalTrials.gov ID
- NCT03486106
- Acronym / sponsor ID
- HM20010566
- Conditions
- Anesthesia; Functional, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 3 Apr 2018 (actual)
- 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.
This study evaluates the effect of music and its influence on anesthetic requirements during total knee replacement surgery. Half of the participants will receive noise-cancelling headphones in the operating room, and the other half of participants will receive noise-cancelling headphones with music playing.
Detailed description
Prior to surgery, patient participants will receive a combined spinal-epidural per VCU total joint protocol; the following steps are considered standard of care and not considered study procedures. The combined spinal-epidural procedure creates complete numbness below the abdomen down to the feet, which negates the need for general anesthesia. For patient comfort during the combined-spinal epidural procedure, a one-time dose of 2 milligrams of intravenous midazolam will be given; this dose is adequate for reducing anxiety while allowing the patient to maintain conversation with health care providers if necessary. The standard intrathecal dose for total knee replacement at our institution is 15 mg bupivacaine and 0.2 mg preservative-free morphine; this dose will provide complete numbness to the lower extremities for approximately 3-6 hours. After this dose is administered, the patient will then be positioned appropriately in the operating room and vital signs will monitored per standard protocol.
Each patient participant will be randomized to one of two groups. Participants in the control group will receive noise-cancelling wireless headphones that will not play any noise throughout the procedure. Participants in the experimental group will receive the same noise-cancelling wireless headphones but will be permitted to listen to the music of their choice while in the operating room. Music will be provided via Spotify, which is an Internet streaming music service, and will be played through headphones; this way, no other individual in the operating room will be distracted or influenced by the patient's music selection. Participants will not be able to change the Spotify channel. We will be using the paid Spotify service with no commercials. If participants opt to have the music stopped, we will withdraw them from the study and continue standard of care. The participants will have the music playing for about two hours. If the participant has no music preference, the music will be chosen for them and it will be the same for all participants that have no preference. The volume will be adjusted in the operating room until the participant approves of the volume by saying "yes, the volume is good" or giving another verbal cue of approval.The music will continue playing until the surgical procedure is complete and the patient has reached the post-anesthesia recovery unit.
As stated previously, spinal anesthesia provides numbness that negates the need for general anesthesia, but patients often times need additional sedation, which will be defined as anesthesia medication that is used to treat patient anxiety and discomfort in the operating room. Patient participants in both groups will receive sedation via the same protocol, which is outlined below.
Sedation will only be given as needed per patient request; the patient will be given a noise-making device (such as a rubber duckie that makes sound when squeezed) that will inform the anesthesia provider that the patient is uncomfortable and needs some sedation. A weight based dose of 0.3 micrograms per kilogram of intravenous propofol will be given for each patient request. This dose is expected to provide amnesia or light sleep for a few minutes. For patient safety, if the patient requests sedation more than once within a two minute window, the anesthesia provider will not administer any more medication during this two minute period. Additionally, the anesthesia provider may withhold sedation if he or she determines with physical exam and hemodynamic monitors that the patient is already over-sedated.
After five propofol boluses have been given to a patient, a propofol continuous infusion will be initiated at 25mcg/kg/min. The patient may still request additional sedation with the request instrument if he or she is still conscious enough to do so. If the anesthesia provider has given more than five boluses even with the baseline propofol infusion, the infusion will be increased to 50mcg/kg/min. In the highly unlikely scenario that five additional boluses are required with a propofol infusion rate of 50 mcg/kg/min, the anesthesia providers and investigators will make a clinical decision as to what is the safest next step.
There may be scenarios that warrant conversion to general anesthesia. These scenarios include, but are not limited to, hemodynamic instability, regurgitation of gastric content, obtundation, excessive agitation, and inadequate spinal anesthesia. The decision to convert to the general anesthesia will be made by the anesthesiologist and anesthesia provider in the operating room; implementation of this study should not prevent or delay this decision if it is necessary.
Documentation will be completed by the anesthesia provider per standard protocol for electronic anesthesia charting at VCU. This will allow for data acquisition by the investigators through the anesthesiology printed record in Cerner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Headphones without music | Placebo comparator | Other: Headphones, Drug: PropofolParticipants in the control group will receive noise-cancelling wireless headphones that will not play any noise throughout the procedure. They will also receive propofol for sedation as needed. |
| Headphones with music | Experimental | Other: Music, Other: Headphones, Drug: PropofolParticipants in the experimental group will receive the same noise-cancelling wireless headphones but will be permitted to listen to the music of their choice while in the operating room. They will also receive propofol for sedation as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- undergoing a primary elective total knee replacement by Dr. Gregory Golladay (VCU surgeon and co-investigator for this research study)
- 18 years of age or older
- eligible for spinal anesthesia (which will be determined by the health care providers during the standard pre-surgery clinic visits)
- mentally capable of understanding instructions on how to request anesthesia medication
- mentally capable of understanding instructions on how to rate pain scores, anxiety level, and patient satisfaction
Key exclusion criteria (6 listed)
- identified as a member of a regulated vulnerable population (one exception: limited English proficiency does not preclude them from this study; translation documents are available)
- ineligibility for spinal anesthesia (which will be determined by the health care providers during the standard pre-surgery clinic visits)
- morbid obesity, BMI greater than 40
- allergy to propofol, midazolam, or morphine
- pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours
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 |
|---|---|---|
| MusicMusic will be provided via Spotify, which is an Internet streaming music service, and will be played through headphones; this way, no other individual in the operating room will be distracted or influenced by the patient's music selection. | Other | Headphones with music |
| HeadphonesAll participants will receive noise-cancelling wireless headphones that they will wear in the operating room during the procedure. | Other | Headphones with music, Headphones without music |
| PropofolAll participants will receive intravenous doses of propofol; the timing and frequency of the doses will be given when the patient indicates (by squeezing a rubber duckie) that he/she wants sedation medication. | Drug | Headphones with music, Headphones without music |
Primary outcome
Intraoperative propofol requirement
Time frame: 2 hours
The amount of propofol given in the operating room divided by duration of operating room time
2 secondary outcomes
Pain score
Time frame: 24 hours
Satisfaction score
Time frame: 72 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 25 May 2023.
- Background: PubMed 28619305Wu PY, Huang ML, Lee WP, Wang C, Shih WM. Effects of music listening on anxiety and physiological responses in patients undergoing awake craniotomy. Complement Ther Med. 2017 Jun;32:56-60. doi: 10.1016/j.ctim.2017.03.007. Epub 2017 Mar 31.
- Background: PubMed 28452603Kahloul M, Mhamdi S, Nakhli MS, Sfeyhi AN, Azzaza M, Chaouch A, Naija W. Effects of music therapy under general anesthesia in patients undergoing abdominal surgery. Libyan J Med. 2017 Dec;12(1):1260886. doi: 10.1080/19932820.2017.1260886.
- Background: PubMed 28302117Li J, Zhou L, Wang Y. The effects of music intervention on burn patients during treatment procedures: a systematic review and meta-analysis of randomized controlled trials. BMC Complement Altern Med. 2017 Mar 17;17(1):158. doi: 10.1186/s12906-017-1669-4.
- Background: PubMed 27125531Alam M, Roongpisuthipong W, Kim NA, Goyal A, Swary JH, Brindise RT, Iyengar S, Pace N, West DP, Polavarapu M, Yoo S. Utility of recorded guided imagery and relaxing music in reducing patient pain and anxiety, and surgeon anxiety, during cutaneous surgical procedures: A single-blinded randomized controlled trial. J Am Acad Dermatol. 2016 Sep;75(3):585-589. doi: 10.1016/j.jaad.2016.02.1143. Epub 2016 Apr 25.
- Background: PubMed 26331434Wang Y, Tang H, Guo Q, Liu J, Liu X, Luo J, Yang W. Effects of Intravenous Patient-Controlled Sufentanil Analgesia and Music Therapy on Pain and Hemodynamics After Surgery for Lung Cancer: A Randomized Parallel Study. J Altern Complement Med. 2015 Nov;21(11):667-72. doi: 10.1089/acm.2014.0310. Epub 2015 Sep 2.
- Individual participant dataSharing planned: No
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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.
Bryant Tran, MD principal investigator
Virginia Commonwealth University
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, Headphones and Propofol in people with Anesthesia; Functional and Surgery, run by Virginia Commonwealth 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 5 inclusion and 6 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 25 May 2023. 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. Some participants in this study may receive a placebo. 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?
Intraoperative propofol requirement (time frame: 2 hours). 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 NCT03486106, which also lists 5 linked publications.
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 25 May 2023.