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Virtual Reality Immersive Relaxation for Total Knee Replacement
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessment 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.
Who is the study for?
This trial is for English-speaking patients aged 60 or older who are having their first total knee replacement surgery under spinal/regional anesthesia. They must have a MoCA score below 10, indicating no moderate to severe dementia, and cannot have seizures, face infections, hearing aids during the procedure, general anesthesia, complex surgeries or certain medical devices.Check my eligibility
What is being tested?
The study tests if VR can reduce sedative needs during knee surgery while keeping patients happy compared to music and fake VR experiences. Participants will be randomly assigned to one of these interventions during their operation.See study design
What are the potential side effects?
Potential side effects may include discomfort with the VR headset or audio equipment. There's also a small risk of motion sickness from VR use. No significant medical side effects are expected as this is non-invasive.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively
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 moreTrial 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.
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
835 Previous Clinical Trials
13,006,535 Total Patients Enrolled
Israel-United States Binational Industrial Research and Development FoundationUNKNOWN
1 Previous Clinical Trials
106 Total Patients Enrolled
XRHealthUNKNOWN
1 Previous Clinical Trials
106 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery with general anesthesia.I have moderate to severe memory loss.I am 60 or older and having a knee replacement at BIDMC with spinal anesthesia.I am scheduled for or have had complex or revision surgeries.I am scheduled for a knee replacement surgery on the same day.I do not speak English.I do not have open wounds or infections on my face or around my eyes.I have a history of seizures or epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: Sham VR + Usual Care Control Group
- Group 2: Music group
- Group 3: Immersive VR group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 clinicialtrials.gov 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
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