AnxietyNCT07845695
Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
A study testing Music via Headphones in people with Anxiety and Osteoarthritis, run by Columbia University at 1 site in United States.
Trial summary
Many patients feel anxious before joint replacement surgery. This anxiety is common - affecting roughly 1 in 3 patients - and research has shown that patients who are more anxious before surgery tend to have more pain afterward and may need more pain medication during recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Osteoarthritis
- What is being tested?
- Music via Headphones
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2026to 21 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults 18 years or older undergoing primary THA, TKA, or UKA for osteoarthritis
- Planned spinal/regional anesthesia
- Willingness to undergo randomization
- Ability to provide informed consent in English
Who cannot join
- Chronic opioid use prior to surgery
- Revision TJA
- Primary diagnosis other than osteoarthritis (e.g., fracture, posttraumatic arthritis, AVN)
- Hearing impairment precluding music listening
- Active psychiatric disorder requiring current pharmacotherapy
- Pregnancy
- Inability to provide informed consent in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center - Milstein Hospital
New York, New York, 10032
Rishi Vas, 214-603-1931, rkv2107@cumc.columbia.edu
About this study
Official title: Does Listening to Music Immediately Before Hip and Knee Arthroplasty Significantly Decrease Peri-op Anxiety and Related Outcomes?
Many patients feel anxious before joint replacement surgery. This anxiety is common - affecting roughly 1 in 3 patients - and research has shown that patients who are more anxious before surgery tend to have more pain afterward and may need more pain medication during recovery. Listening to music before medical procedures has been shown to reduce anxiety in many types of surgery. In fact, a recent analysis of 20 studies found that music works about as well as anti-anxiety medication for calming patients before surgery, with about 1 in 4 patients experiencing a meaningful benefit. However, almost all of this research has been done in other types of surgery. No study has specifically tested whether letting patients listen to their own preferred music before hip or knee replacement surgery reduces their anxiety.
This study will randomly assign 52 patients scheduled for hip or knee replacement surgery to one of two groups: one group will listen to music of their choice through noise-cancelling headphones while waiting for surgery (for at least 20 minutes), and the other group will receive the usual preoperative care without music. Patients will fill out a brief 6-question anxiety survey when they arrive in the preoperative area and again just before being taken to the operating room. The study will also ask patients about their pain, anxiety, and overall experience after surgery, and will review their medical charts to see how much sedation and pain medication was used during the procedure. If music is shown to reduce anxiety in this setting, it could be easily adopted by any hospital at very low cost, offering patients a simple, drug-free way to feel calmer before their surgery.
Read the detailed description
Preoperative anxiety affects 20-33% of patients undergoing total joint arthroplasty (TJA) and is independently associated with worse postoperative pain, higher opioid consumption, and lower functional outcomes. Music intervention is a well-established non-pharmacologic anxiolytic, with meta-analytic evidence demonstrating a standardized mean difference (SMD) of 0.72 (95% CI 0.92 to 0.53) for perioperative anxiety reduction using validated instruments, corresponding to a number needed to treat (NNT) of 4. However, the evidence base derives predominantly from general surgical populations. The only systematic review specific to hip and knee surgery identified just 10 studies of mixed quality and explicitly called for larger, well-designed randomized controlled trials (RCTs) in this population. No RCT has examined patient-preferred preoperative music specifically in TJA patients undergoing spinal anesthesia.
Objective: To determine whether patient-preferred music delivered via noise-cancelling headphones during the preoperative holding period reduces acute preoperative anxiety in patients undergoing primary total hip arthroplasty (THA), total knee arthroplasty (TKA), or unicompartmental knee arthroplasty (UKA) under spinal anesthesia.
Methods: This is a prospective, single-center, two-arm, parallel-group RCT. Fifty-two patients (26 per group) undergoing primary THA, TKA, or UKA for osteoarthritis under spinal anesthesia will be randomized 1:1 to either (1) standard preoperative care plus patient-preferred music via Bose QuietComfort noise-cancelling headphones (minimum 20 minutes, continuing until OR transport) or (2) standard preoperative care alone. The primary outcome is the change in prorated STAI-6 score (20-80 scale) from arrival in the preoperative holding area (T1) to immediately before OR transport (T2). Secondary outcomes include postoperative anxiety (NRS 0-10), pain (NRS 0-10), global surgical experience (NRS 0-10), and intraoperative sensory recall. Exploratory chart-review outcomes include total sedation and intraoperative opioid consumption.
Significance: This study addresses a gap explicitly identified in the literature by providing the first RCT of patient-preferred preoperative music in TJA patients under spinal anesthesia. If effective, the intervention is immediately implementable at negligible cost and could reduce reliance on pharmacologic anxiolytics in the preoperative setting.
- Conditions
- Anxiety, Osteoarthritis
- Being tested
- Music via Headphones
- Medical subject headings
- Anxiety Disorders, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music via HeadphonesOther
Patient-selected music will be played through their headphones
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention | Experimental | Patient selected music played through noise-canceling Bose headphones for at least 20 minutes, along with measurements of their anxiety levels before administration, before surgery, and after surgery. Receives: Other: Music via Headphones |
| Control group | No intervention | No intervention. Measurements of their anxiety levels before administration, before surgery, and after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Score as Measured by the Six-Item Short Form of the Spielberger State-Trait Anxiety Inventory (STAI-6)
The STAI-6 is a validated 6-item short form of the state anxiety subscale of the Spielberger State-Trait Anxiety Inventory. Each item is scored from 1 to 4, for a raw total of 6 to 24. The raw total is prorated to the full-scale equivalent (multiplied by 20/6), giving a score range of 20 to 80. Higher scores indicate greater anxiety (worse outcome). The outcome is the change in prorated score from arrival in the preoperative holding area (T1) to immediately before transport to the operating room (T2).
Measured: Day of surgery: from arrival in the preoperative holding area to immediately before transport to the operating room (approximately 20 minutes to 2 hours)
Secondary outcomes (4)
Postoperative Anxiety Measured by Numeric Rating Scale (NRS)
Self-reported anxiety on an 11-point numeric rating scale from 0 (no anxiety) to 10 (worst anxiety imaginable). Higher scores indicate greater anxiety (worse outcome).
Measured: Postoperatively in the post-anesthesia care unit (PACU), within 24 hours after surgery
Postoperative Pain Measured by Numeric Rating Scale (NRS)
Self-reported pain on an 11-point numeric rating scale from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain (worse outcome).
Measured: Postoperatively in the PACU, within 24 hours after surgery
Global Surgical Experience Measured by Numeric Rating Scale (NRS)
Patient-reported overall satisfaction with the perioperative experience on an 11-point numeric rating scale from 0 (worst possible experience) to 10 (best possible experience). Higher scores indicate a better experience (better outcome).
Measured: Postoperatively, within 24 hours after surgery
Intraoperative Sensory Recall
Proportion of participants reporting recall of intraoperative sensory experiences (e.g., sounds, conversations, sensations), assessed with a structured postoperative questionnaire. Responses are recorded as yes/no for each sensory domain. Reported recall is considered a worse outcome.
Measured: Postoperatively, within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start22 Sep 2026
- Primary completion21 Mar 2027 (estimated)
- Study completion21 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Music played through Bose headphones
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roshan P. Shah, Columbia University
- Investigators
- Roshan P Shah, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845695
- Sponsor's protocol ID
- ACYY1449
- Status last verified
- Nov 2026
- First submitted
- 23 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data (IPD) with other researchers. This is a single-center trial, and participant consent did not include sharing individual-level data outside the study team. De-identified data underlying published results may be made available upon reasonable request to the principal investigator, subject to institutional review board approval and a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Listening to Music Immediately Before Hip and Knee Arthroplasty Significantly Decrease Peri-op Anxiety and Related Outcomes?
- ClinicalTrials.gov ID
- NCT07845695
- Acronym / sponsor ID
- ACYY1449
- Conditions
- Anxiety, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- 21 Mar 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
Many patients feel anxious before joint replacement surgery. This anxiety is common - affecting roughly 1 in 3 patients - and research has shown that patients who are more anxious before surgery tend to have more pain afterward and may need more pain medication during recovery. Listening to music before medical procedures has been shown to reduce anxiety in many types of surgery. In fact, a recent analysis of 20 studies found that music works about as well as anti-anxiety medication for calming patients before surgery, with about 1 in 4 patients experiencing a meaningful benefit. However, almost all of this research has been done in other types of surgery. No study has specifically tested whether letting patients listen to their own preferred music before hip or knee replacement surgery reduces their anxiety.
This study will randomly assign 52 patients scheduled for hip or knee replacement surgery to one of two groups: one group will listen to music of their choice through noise-cancelling headphones while waiting for surgery (for at least 20 minutes), and the other group will receive the usual preoperative care without music. Patients will fill out a brief 6-question anxiety survey when they arrive in the preoperative area and again just before being taken to the operating room. The study will also ask patients about their pain, anxiety, and overall experience after surgery, and will review their medical charts to see how much sedation and pain medication was used during the procedure. If music is shown to reduce anxiety in this setting, it could be easily adopted by any hospital at very low cost, offering patients a simple, drug-free way to feel calmer before their surgery.
Detailed description
Preoperative anxiety affects 20-33% of patients undergoing total joint arthroplasty (TJA) and is independently associated with worse postoperative pain, higher opioid consumption, and lower functional outcomes. Music intervention is a well-established non-pharmacologic anxiolytic, with meta-analytic evidence demonstrating a standardized mean difference (SMD) of 0.72 (95% CI 0.92 to 0.53) for perioperative anxiety reduction using validated instruments, corresponding to a number needed to treat (NNT) of 4. However, the evidence base derives predominantly from general surgical populations. The only systematic review specific to hip and knee surgery identified just 10 studies of mixed quality and explicitly called for larger, well-designed randomized controlled trials (RCTs) in this population. No RCT has examined patient-preferred preoperative music specifically in TJA patients undergoing spinal anesthesia.
Objective: To determine whether patient-preferred music delivered via noise-cancelling headphones during the preoperative holding period reduces acute preoperative anxiety in patients undergoing primary total hip arthroplasty (THA), total knee arthroplasty (TKA), or unicompartmental knee arthroplasty (UKA) under spinal anesthesia.
Methods: This is a prospective, single-center, two-arm, parallel-group RCT. Fifty-two patients (26 per group) undergoing primary THA, TKA, or UKA for osteoarthritis under spinal anesthesia will be randomized 1:1 to either (1) standard preoperative care plus patient-preferred music via Bose QuietComfort noise-cancelling headphones (minimum 20 minutes, continuing until OR transport) or (2) standard preoperative care alone. The primary outcome is the change in prorated STAI-6 score (20-80 scale) from arrival in the preoperative holding area (T1) to immediately before OR transport (T2). Secondary outcomes include postoperative anxiety (NRS 0-10), pain (NRS 0-10), global surgical experience (NRS 0-10), and intraoperative sensory recall. Exploratory chart-review outcomes include total sedation and intraoperative opioid consumption.
Significance: This study addresses a gap explicitly identified in the literature by providing the first RCT of patient-preferred preoperative music in TJA patients under spinal anesthesia. If effective, the intervention is immediately implementable at negligible cost and could reduce reliance on pharmacologic anxiolytics in the preoperative setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Music played through Bose headphones
| Arm | Type | Receives |
|---|---|---|
| Music Intervention | Experimental | Other: Music via HeadphonesPatient selected music played through noise-canceling Bose headphones for at least 20 minutes, along with measurements of their anxiety levels before administration, before surgery, and after surgery. |
| Control group | No intervention | –No intervention. Measurements of their anxiety levels before administration, before surgery, and after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18 years or older undergoing primary THA, TKA, or UKA for osteoarthritis
- Planned spinal/regional anesthesia
- Willingness to undergo randomization
- Ability to provide informed consent in English
Key exclusion criteria (7 listed)
- Chronic opioid use prior to surgery
- Revision TJA
- Primary diagnosis other than osteoarthritis (e.g., fracture, posttraumatic arthritis, AVN)
- Hearing impairment precluding music listening
- Active psychiatric disorder requiring current pharmacotherapy
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 via HeadphonesPatient-selected music will be played through their headphones | Other | Music Intervention |
Primary outcome
Change in State Anxiety Score as Measured by the Six-Item Short Form of the Spielberger State-Trait Anxiety Inventory (STAI-6)
Time frame: Day of surgery: from arrival in the preoperative holding area to immediately before transport to the operating room (approximately 20 minutes to 2 hours)
The STAI-6 is a validated 6-item short form of the state anxiety subscale of the Spielberger State-Trait Anxiety Inventory. Each item is scored from 1 to 4, for a raw total of 6 to 24. The raw total is prorated to the full-scale equivalent (multiplied by 20/6), giving a score range of 20 to 80. Higher scores indicate greater anxiety (worse outcome). The outcome is the change in prorated score from arrival in the preoperative holding area (T1) to immediately before transport to the operating room (T2).
4 secondary outcomes
Postoperative Anxiety Measured by Numeric Rating Scale (NRS)
Time frame: Postoperatively in the post-anesthesia care unit (PACU), within 24 hours after surgery
Postoperative Pain Measured by Numeric Rating Scale (NRS)
Time frame: Postoperatively in the PACU, within 24 hours after surgery
Global Surgical Experience Measured by Numeric Rating Scale (NRS)
Time frame: Postoperatively, within 24 hours after surgery
Intraoperative Sensory Recall
Time frame: Postoperatively, within 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data (IPD) with other researchers. This is a single-center trial, and participant consent did not include sharing individual-level data outside the study team. De-identified data underlying published results may be made available upon reasonable request to the principal investigator, subject to institutional review board approval and a data use agreement.
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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.
Roshan P Shah, MD principal investigator
Columbia 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 via Headphones in people with Anxiety and Osteoarthritis, run by Columbia 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rishi Vas (214-603-1931, rkv2107@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Score as Measured by the Six-Item Short Form of the Spielberger State-Trait Anxiety Inventory (STAI-6) (time frame: Day of surgery: from arrival in the preoperative holding area to immediately before transport to the operating room (approximately 20 minutes to 2 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 4 Nov 2026.