Recruiting

Active Noise Cancelling

Sponsor:

Mayo Clinic

Code:

NCT07371390

Conditions

Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active Noise Cancelling Headset System

Study Details

Brief summary:

This study will test the use of active noise cancelling headphones with music or a movie during knee replacement surgery. Feedback from the surgical team and from patients regarding the headset system will be gathered to see if using it can reduce the amount of sedation needed during knee replacement procedures that use localized anesthesia.

Conditions

Total Knee Arthroplasty

Study ID

NCT07371390

Start date

Dec 11, 2025

Status verified date

Jan, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Nov 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary Total Knee Arthroplasty
  • Indicated for Spinal Anesthesia
  • 18+ years old
  • Participant can independently provide informed consent

Exclusion Criteria:

  • Unicompartmental Knee Arthroplasty
  • Revision Knee Arthroplasty

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: No active noise cancelling headset

This arm will serve as the control group for this randomized trial. Patients in this arm will receive normal standard of care anesthesia during their total knee arthroplasty.

experimental: Active Noise Cancelling Headset

This arm will provide patients with an active noise cancelling headset system that they may use to select music or a movie for audiovisual distraction during the surgery.

Interventions

Active Noise Cancelling Headset System

The ANC Headset will allow patients to select music or a movie for audiovisual distraction during their surgery. This can be used when patients are not receiving general anesthesia (full sedation) for their surgery.

Primary outcome measure

  • Mean Richmond Agitation-Sedation Scale(RASS) Score [ Time Frame: 30 minutes intraoperatively ]
  • Protocol Completion [ Time Frame: Intraoperatively ]
  • Mean Propofol Infusion Rate [ Time Frame: Intraoperatively ]

Central Contacts and Locations

Central contacts

Gabriel D Schouten

507-266-5895schouten.gabriel@mayo.edu

Matthew Hoplin

507-284-1003hoplin.matthew@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Gabriel D Schouten

507-266-5895schouten.gabriel@mayo.edu

Matthew Hoplin

507-284-1003hoplin.matthew@mayo.edu

Principal Investigator:

Matthew P Abdel, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Keywords

  • Spinal Anesthesia
  • Minimal Sedation
  • Total Knee Arthroplasty
  • Knee Replacement
  • Audiovisual Distraction
  • Localized Anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-27.