Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 maintaining high levels of patient satisfaction as compared to both a music and sham VR + usual care control.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia

• English or Spanish speaking patients

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Contact Information
Primary
Brian P O'Gara, MD,MPH
bpogara@bidmc.harvard.edu
617-754-3189
Backup
Anna Fratello, B.S.
afratell@bidmc.harvard.edu
Time Frame
Start Date: 2022-04-11
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 131
Treatments
Experimental: Immersive VR group
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.
Active_comparator: Music group
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.
Sham_comparator: Sham VR + Usual Care Control Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Israel-United States Binational Industrial Research and Development Foundation, XRHealth
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov