Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty

NCT07845695 | Recruiting

• 1 other identifier: ACYY1449
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Osteoarthritis

Outcome Measures

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).

  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)

  Postoperatively in the post-anesthesia care unit (PACU), within 24 hours after surgery

• Postoperative Pain Measured by Numeric Rating Scale (NRS)

  Postoperatively in the PACU, within 24 hours after surgery

• Global Surgical Experience Measured by Numeric Rating Scale (NRS)

  Postoperatively, within 24 hours after surgery

• Intraoperative Sensory Recall

  Postoperatively, within 24 hours after surgery

Study Arms (2)

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.

Other: Music via Headphones

Control group

NO INTERVENTION

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

Interventions

Music via Headphones OTHER

Patient-selected music will be played through their headphones

Music Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center - Milstein Hospital

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Osteoarthritis

Condition Hierarchy (Ancestors)

Mental Disorders; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Roshan P Shah, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rishi Vas

CONTACT

214-603-1931; rkv2107@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Russell A. Hibbs Associate Professor of Orthopedics (in Orthopedic Surgery and in Surgery)

Model Details: Music played through Bose headphones

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): March 21, 2027
• Study Completion (Estimated): March 21, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)