Binaural beats to reduce pain and anxiety after hip or knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing ambulatory primary total knee or total hip arthroplasty under spinal anesthesia with a postoperative nerve block will receive a 30-minute binaural beats audio intervention in the post-anesthesia care unit (PACU). Pain and anxiety outcomes will be collected immediately after surgery and again four hours after surgery completion. The intervention is compared with music of the patient's choice as an alternative audio exposure. The approach tests a brief, non-pharmacologic method for short-term postoperative symptom relief.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* American Society of Anesthesiologists Physical Status Classification System (ASA) 1-3
* Spinal anesthesia
* Patients receiving nerve-block in Post-Anesthesia Care Unit (PACU)
* Primary total hip or total knee arthroplasty

Exclusion Criteria:

* Moderate-severe hearing impairment or use of hearing aids
* History of significant tinnitus, active delirium, chronic high-dose opioid therapy (\>60 MME/day baseline)
* Major psychiatric pathology
* General anesthesia

Where it's running

• Univeristy of Miami Health System
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Victor H Hernandez, MD, MSc — University of Miami
• Study coordinator: Andrew R Moya, MD
• Email: arm577@miami.edu, doc.a.moya1@gmail.com
• Phone: 1786-856-6463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.