ClinicalTrials.gg
RecruitingNCT07845695Updated Nov 4, 2026

Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty

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 2026-11-04.

Primary conditionOsteoarthritisRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Osteoarthritis
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Osteoarthritis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Columbia University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 4, 2026Start date movedNewly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,029 studies in Osteoarthritis with a site in United States — 116 open to participants now, 175 under way, 14 of them phase 3. Osteoarthritis · United States.

Planned enrollment
572nd of 832
52 · median 100
Started
2026
with 36 others
No phase
437 of 1,029
54 open now
Primary completion
2027-03
later than 81 of 174 live
Registered
1,026th of 1,029
by date

Among the 1,029 studies in Osteoarthritis with a site in United States, this one is the 572nd largest by planned enrollment of the 832 interventional ones that give a count, is one of 37 that started in 2026, is one of 437 with no phase, reaches primary completion later than 81 of the 174 other live ones, and was the 1,026th registered.

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 435 are open to participants now.

Browse Osteoarthritis studies →

Open to participants now

116 of the 1,029 studies in Osteoarthritis with a site in United States are open now. Recruiting first, the newest first:

110 more — sign in →

All 116 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 285 Osteoarthritis studies recruiting now, 157 (55%) set no upper age limit and 71 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,029 studies in Osteoarthritis with a site in United States, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Anxiety
  • Osteoarthritis

Browse trials for

04

In context

Osteoarthritis Reclassified

2,974 studies on the registry are indexed under Osteoarthritis; 435 are open to participants now.

This study's planned enrollment of 52 is below the median of 80 across 2,239 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.

Of its 181 completed or terminated interventional studies of FDA-regulated products, 149 (82%) have results posted.

Compared within Osteoarthritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults 18 years or older undergoing primary THA, TKA, or UKA for osteoarthritis
  • Planned spinal/regional anesthesia
  • Willingness to undergo randomization
  • Ability to provide in English

Exclusion criteria

Exclusion Criteria:

  • 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 in English
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    Music Intervention

    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
    Control group

    No intervention. Measurements of their anxiety levels before administration, before surgery, and after surgery.

Interventions

  • OtherMusic via Headphones

    Patient-selected music will be played through their headphones

07

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

08

Study locations

1 of 1 sites recruiting
  • Columbia University Irving Medical Center - Milstein Hospital
    New York, New York 10032, United States
    Recruiting
09

References and documents

Individual participant data

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.

No publications or documents are linked to this record.

10

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 5 months after the start.

Of 576 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 5 months is below that.

Counting every sponsor, half of 711 studies reached it within 28 months; a quarter within 11 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 23, 2026
First posted
Sep 29, 2026
StartActual
Sep 22, 2026
Primary completionEst.
Mar 21, 2027
CompletionEst.
Mar 21, 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 30, 2026→Sep 22, 2026 (actual)
Nov 4, 2026
Registered
First appeared on the registry
Sep 29, 2026
Show all 2 updates
  1. Nov 4, 2026
    Start date Sep 30, 2026→Sep 22, 2026 (now actual)
    + 1 other change: verification date
  2. Sep 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07845695
Responsible party
Roshan P. Shah (Russell A. Hibbs Associate Professor of Orthopedics (in Orthopedic Surgery and in Surgery), Columbia University) — Principal investigator
First posted
Sep 29, 2026
Start date
Sep 22, 2026
Primary completion
Mar 21, 2027 (estimated)
Completion
Mar 21, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Rishi Vas
Contact
rkv2107@cumc.columbia.edu
214-603-1931
Roshan P Shah, MD
principal investigator · Columbia University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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