An interventional study of Music via Headphones in Anxiety and Osteoarthritis, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Columbia University · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
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.
Other: Music via Headphones
No intervention. Measurements of their anxiety levels before administration, before surgery, and after surgery.
Patient-selected music will be played through their headphones
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).
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)
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Postoperatively, within 24 hours after surgery
Plan to share: 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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