Virtual Reality for Total Knee Replacement

Overseen By Anna Fratello, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Seizures, Pacemaker, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day (procedure duration 1 to 3 hours)

131 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) during total knee replacement surgery can reduce the need for sedatives without affecting patient satisfaction. Participants will experience one of three options: immersive VR (Virtual Reality Immersive Relaxation), music (Immersive Audio Experience), or a control setup with no content (Sham Virtual Reality Experience). The researchers aim to determine if VR can make the surgery more comfortable with less medication. This trial suits individuals aged 60 or older undergoing their first knee replacement with regional anesthesia who speak English or Spanish. As an unphased trial, it offers a unique opportunity to explore innovative ways to enhance surgical experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that virtual reality is safe for use during total knee arthroplasty?

Research has shown that virtual reality (VR) can be helpful in medical settings. In studies with patients who underwent knee surgery, VR reduced pain and improved knee function afterward. It also enhanced patients' mental well-being during recovery.

Another study explored using VR during knee surgery itself. The results suggested that VR could reduce the need for sedatives during the operation, meaning patients might require fewer drugs to stay calm and comfortable.

Overall, these studies indicate that VR is generally well-tolerated and may enhance the surgical experience. No major problems have been reported when using VR in these ways, suggesting it is a safe option for patients considering clinical trials involving VR. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these virtual reality (VR) treatments for total knee replacement because they offer a unique approach to pain and anxiety management without relying solely on medications like opioids or sedatives. The Immersive VR group allows patients to choose calming virtual environments, like a peaceful meadow or river, and even control their own sedation levels, potentially increasing their comfort and sense of control during recovery. Meanwhile, the Music group provides an alternative by letting patients listen to personalized audio content, which may help reduce stress and discomfort. These innovative methods aim to enhance patient experience and potentially minimize the need for traditional sedatives, which can have side effects.

What evidence suggests that virtual reality is effective for reducing sedative requirements during total knee replacement?

Research has shown that virtual reality (VR) can ease pain and improve movement for individuals recovering from knee surgery. In this trial, participants in the Immersive VR group will choose from a selection of immersive environments and guided meditations to experience these potential benefits. Studies have found that VR can also boost mood, enhancing the rehabilitation process. Meanwhile, the Music group will listen to preselected music or audible content, while the Sham VR + Usual Care Control Group will not view or listen to any content. VR has reduced the need for sedatives, like propofol, during surgery by helping patients remain calm. Early results suggest that the benefits of VR might last for months after surgery, potentially making the surgery and recovery more comfortable and satisfying for patients. ^{2 3 4 5 6}

Who Is on the Research Team?

Brian P O'Gara, MD,MPH

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am 60 or older and having a knee replacement at BIDMC with spinal anesthesia.

Exclusion Criteria

I am scheduled for surgery with general anesthesia.

I have moderate to severe memory loss.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo total knee arthroplasty with either immersive VR, music, or sham VR + usual care, with self-administered sedation

1 day (procedure duration 1 to 3 hours)

Postoperative Recovery

Participants are monitored in the Post Anesthesia Care Unit (PACU) and assessed for pain, satisfaction, and recovery

1 to 5 hours in PACU

Follow-up

Participants are monitored for safety, effectiveness, and cognitive recovery post-surgery

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Immersive Audio Experience
• Sham Virtual Reality Experience
• Virtual Reality Immersive Relaxation

Trial Overview 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.

How Is the Trial Designed?

Group I: Immersive VR group Experimental Treatment 1 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 group Active Control 1 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 Group Placebo Group 1 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.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

XRHealth

Collaborator

Trials

2

Recruited

240+

Israel-United States Binational Industrial Research and Development Foundation

Collaborator

Trials

2

Recruited

240+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8769147/

Virtual reality-based rehabilitation in patients following total ... VR-based rehabilitation improved pain and function but not postural control following TKA compared to conventional rehabilitation.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1878124124000443

Review article Application of virtual reality technology in ... VR technology proves feasible in the rehabilitation of TKA patients, effectively alleviating pain, enhancing psychological states, and improving joint function ...

3. bfpt.springeropen.com bfpt.springeropen.com/articles/10.1186/s43161-024-00246-y

Efficacy of virtual reality-based rehabilitation following total ... Immersive and non-immersive VRBR are effective following TKR. The effect on pain and function may be sustained over three or six months.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06933732

Study Details | NCT06933732 | Effect of Virtual Reality on ... This study aims to evaluate the effectiveness of virtual reality (VR) in managing preoperative anxiety and postoperative pain in patients undergoing total ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08551-6

Intraoperative virtual reality for older patients undergoing total ... We hypothesize that the use of immersive VR during total knee arthroplasty (TKA) will lead to decreased propofol requirements, improved patient-reported ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8857886/

Virtual reality rehabilitation following total knee arthroplasty VR-based rehabilitation demonstrated improved functional outcomes at 12 weeks (n = 353) postoperatively [mean difference (MD) − 3.32, 95% ...