Status:
RECRUITING
Intraoperative VR for Older Patients Undergoing TKA
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Israel-United States Binational Industrial Research and Development Foundation
XRHealth
Conditions:
Total Knee Arthroplasty
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The objective of this study is to investigate whether the use of virtual reality (VR) during total knee arthroplasty (TKA) can facilitate reductions in intraoperative sedative requirements while maint...
Detailed Description
The investigators will conduct a three-armed randomized controlled trial with the following aims: Specific Aim 1: Evaluate whether the use of VR during TKA can facilitate a reduction in intraoperativ...
Eligibility Criteria
Inclusion
- Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia
- English or Spanish speaking patients
Exclusion
- 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)
Key Trial Info
Start Date :
April 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT04748549
Start Date
April 11 2022
End Date
December 30 2027
Last Update
June 4 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215