Using virtual reality to reduce sedation in older patients during knee surgery
Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
NA · Beth Israel Deaconess Medical Center · NCT04748549
This study is testing if using virtual reality can help older patients feel less anxious and need less sedation during knee surgery compared to listening to music or a fake VR experience.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 131 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04748549 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of virtual reality (VR) in reducing the need for sedatives during total knee arthroplasty (TKA) in older patients. It is a three-armed randomized controlled trial comparing VR to music and a sham VR experience alongside usual care. The study aims to evaluate patient satisfaction, pain, and anxiety levels, as well as other outcomes like recovery time and cognitive function post-surgery. The goal is to determine if VR can enhance the surgical experience while minimizing medication use.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60 or older undergoing primary total knee replacement surgery with spinal or regional anesthesia.
Not a fit: Patients with complex surgeries, severe dementia, or those requiring general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to lower sedative requirements and improved patient satisfaction during knee surgeries.
How similar studies have performed: Other studies have shown promising results using VR in surgical settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia * English or Spanish speaking patients Exclusion Criteria: * Complex or revision surgeries * Patients scheduled for "same day" TKA * Open wounds or active infection of the face or eye area * History of seizures or other symptom linked to an epileptic condition * Patients who plan to wear hearing aids during the procedure * Patients with a pacemaker or other implanted medical device * Droplet or airborne precautions (as determined by local infection control policy) * Non-English speaking or Non-Spanish speaking * Moderate to severe dementia Drop-Out Criteria: * MoCA \<10 (this test will be administered on Day of Enrollment)
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Brian P O'Gara, MD,MPH — Beth Israel Deaconess Medical Center
- Study coordinator: Brian P O'Gara, MD,MPH
- Email: bpogara@bidmc.harvard.edu
- Phone: 617-754-3189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Total Knee Arthroplasty, Virtual Reality