NCT04748549

Intraoperative VR for Older Patients Undergoing TKA

Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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 intraoperative propofol dose required for patient comfort as compared to music and sham VR + usual care controls. Hypotheses: Patients in both the VR and music groups will demonstrate reductions in propofol dose compared to sham VR + usual care controls. A reduction in propofol dose between the VR and music group will be smaller in magnitude. Specific Aim 2: Assess the effect of VR during TKA on patient reported outcomes including overall satisfaction, pain, and anxiety as compared to music and sham VR + usual care controls. Hypotheses: Patients in the VR group will report significantly higher satisfaction and better control of pain and anxiety than those in the music group and usual care group. Specific Aim 3: Explore the potential effects of VR during TKA on other key secondary outcomes of perioperative efficiency, postoperative cognition, and functional recovery. Hypotheses: Patients in the VR group will have shorter post-anaesthesia care unit (PACU) length of stay as compared to sham VR + usual care controls. The effect of VR on postoperative delirium, postoperative cognitive decline, postoperative opioid use and functional recovery will be exploratory endpoints.

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
OTHER	Virtual Reality Immersive Relaxation	The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.
OTHER	Immersive Audio Experience	A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient.
OTHER	Sham Virtual Reality Experience	Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.

Timeline

• Start date: 2022-04-11
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2021-02-10
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States