200 Participants Needed

Active Noise Cancelling Headset for Total Knee Replacement

GD
MH
Overseen ByMatthew Hoplin
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether active noise-canceling headphones with music or movies during knee replacement surgery can reduce the amount of sedation needed. The goal is to make the surgical experience more comfortable by potentially lowering stress and anxiety. The trial includes two groups: one uses the Active Noise Cancelling Headset System, while the other does not, serving as a comparison. Candidates may be suitable if undergoing a first total knee replacement and will be awake with spinal anesthesia. As an unphased trial, this study offers a unique opportunity to explore innovative methods to enhance the surgical experience.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using noise-cancelling headphones during surgery, so it's best to ask the trial coordinators for guidance.

What prior data suggests that this active noise cancelling headset system is safe for use during knee replacement surgery?

Research has shown that active noise-canceling headsets are generally safe during knee replacement surgery. One study found that patients using these headsets with music experienced less pain and anxiety compared to those with regular headsets. No harmful effects from the headsets themselves were reported.

Another study examined the safety of these headsets during surgery and found no safety issues, indicating that patients can use them without problems. Since the study available for participation is not testing a new drug or medical device but rather a tool to manage noise and potentially reduce sedation needs, the safety risks are minimal.12345

Why are researchers excited about this trial?

Researchers are excited about using active noise cancelling headsets during total knee replacements because they offer a unique way to improve patient experience without altering the surgical procedure itself. Unlike standard anesthesia alone, these headsets provide audiovisual distractions like music or movies, potentially reducing anxiety and discomfort during surgery. This approach could enhance patient satisfaction and comfort by creating a more relaxed environment, which is a fresh take compared to traditional methods of managing surgical stress.

What evidence suggests that the active noise cancelling headset system is effective for reducing sedation during knee replacement surgery?

Research has shown that using active noise-cancelling headphones with music during knee replacement surgery can help reduce pain and anxiety. In this trial, one group of participants will use an active noise-cancelling headset system during their surgery, choosing music or a movie for audiovisual distraction. An earlier study suggested that while the surgical staff did not experience a clear benefit, patients might still feel less stressed. Overall, these headphones could make the surgery experience more comfortable for patients by reducing the need for sedation.12678

Who Is on the Research Team?

MP

Matthew P Abdel, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals undergoing knee replacement surgery. Participants should be eligible for localized anesthesia during the procedure and willing to use an active noise cancelling headset system.

Inclusion Criteria

I can make my own medical decisions.
I am having my first knee replacement surgery.
I am a candidate for spinal anesthesia.
See 1 more

Exclusion Criteria

I have had a partial knee replacement.
I am scheduled for or have had a revision knee surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo knee replacement surgery with either standard care or active noise cancelling headsets

Intraoperative

Immediate Post-operative

Participants are monitored for anesthetist, patient, and surgeon satisfaction within 48 hours post-operatively

48 hours

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Active Noise Cancelling Headset System

Trial Overview

The study is testing whether using an active noise cancelling headset with music or a movie can reduce the need for sedation in patients having knee replacement surgery under localized anesthesia.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Active Noise Cancelling HeadsetExperimental Treatment1 Intervention
Group II: No active noise cancelling headsetActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Failed Attempt to Recommend Noise Cancelling Headphones ...

Results: There was no perceived benefit of ANCH for the surgeons (p = 0.648), assistants (p = 0.908) and scrub nurses (p = 0.251). There was an ...

Effect of Noise Control During Total Knee Arthroplasty

This study compares the effect of passive noise-cancellation versus active noise cancellation with music on pain, vital signs and anxiety during elective total ...

Noisy Robots? Comparison of Occupational Noise Levels ...

In this prospective observational study, we collected noise exposure data during total knee arthroplasty with and without robotic assistance. Noise levels were ...

Noise exposure on surgeons using robotic surgical ...

This study assessed noise levels associated with the Mako robotic surgical system in the performance of total knee replacement (TKR) surgeries.

Noise Control Methods and Music Therapy Effects ...

Conclusion: Noise control methods and music therapy during TKR surgery may help reduce postoperative pain and situational anxiety and may partially stabilize ...

Minimal Sedation During Knee Replacement Surgery

Overview. This study will test the use of active noise cancelling headphones with music or a movie during knee replacement surgery.

Minimal Sedation During Knee Replacement Surgery

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 ...

Active Noise Cancelling Headset for Total Knee ...

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 ...