Virtual Reality Immersive Relaxation for Total Knee Replacement

Led By Brian P O'Gara, MD,MPH
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upassessment will take place on day of enrollment and then at one week (+/- 48 hours) and one month postoperatively (+/- 7 days).
Awards & highlights

Study Summary

This trial will compare VR, music, and sham VR to see if VR can help reduce the amount of sedatives needed during TKA while still maintaining patient satisfaction.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intraoperative Propofol Dose
Secondary outcome measures
Assessment of Knee Pain and Function
Delayed Cognitive Recovery and Postoperative Neurocognitive Disorder
Intraoperative Anesthesia Maneuvers
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Immersive VR groupExperimental Treatment1 Intervention
Patients in the Immersive VR group will don a VR headset connected to a software platform on a tablet, as well as noise cancelling headphones. Patients can choose their desired experience within the VR software from a selection of immersive environments and/or video content. Examples include sitting in a canoe on a river, on a peaceful meadow or in a forest. Patients also have the option to listen to guided meditation or select from a library of videos to watch on a web-based user interface. To reduce the influence of the anesthesia provider on the determination of sedative requirements, patients will administer their own sedation according to their needs for relaxation and comfort using a patient controlled system.
Group II: Music groupActive Control1 Intervention
Patients randomized to the Music group will be equipped with VR headsets but won't view any content. They will also be equipped with noise cancelling headphones in the same fashion as the immersive VR group. A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient. Patients in the Sham VR group will also use patient controlled sedation.
Group III: Sham VR + Usual Care Control GroupPlacebo Group1 Intervention
Subjects in the control group will wear VR headsets and headphones but will not view any content or listen to any audible content. They will undergo Monitored Anesthesia Care (MAC) according to a prespecified protocol targeting light or moderate sedation with a propofol infusion.

Find a site

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
822 Previous Clinical Trials
6,993,964 Total Patients Enrolled
Israel-United States Binational Industrial Research and Development FoundationUNKNOWN
1 Previous Clinical Trials
106 Total Patients Enrolled
1 Previous Clinical Trials
106 Total Patients Enrolled

Media Library

Virtual Reality Immersive Relaxation Clinical Trial Eligibility Overview. Trial Name: NCT04748549 — N/A
Total Knee Replacement Research Study Groups: Sham VR + Usual Care Control Group, Music group, Immersive VR group
Total Knee Replacement Clinical Trial 2023: Virtual Reality Immersive Relaxation Highlights & Side Effects. Trial Name: NCT04748549 — N/A
Virtual Reality Immersive Relaxation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04748549 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size for this research endeavor?

"Indeed, the information on indicates that recruitment for this trial is ongoing. The study was first published on April 11th 2022 and subsequently edited in October 19th of the same year. This medical experiment requires 130 individuals from a single location to participate."

Answered by AI

Is enrollment for this trial currently available?

"This medical trial, which was initially published on April 11th 2022, is actively looking for participants. The most recent update to the study took place on October 19th 2022."

Answered by AI
~54 spots leftby Oct 2024