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Virtual Reality 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

Must not have

Patients booked to receive general anesthesia

Moderate to severe dementia

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).

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for surgery with general anesthesia.

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I have moderate to severe memory loss.

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I am scheduled for or have had complex or revision surgeries.

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I am scheduled for a knee replacement surgery on the same day.

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I do not speak English.

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I do not have open wounds or infections on my face or around my eyes.

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I have a history of seizures or epilepsy.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intraoperative Propofol Dose

Secondary study objectives

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.

0 / 7Eligibility criteria met