Intraoperative VR for Older Patients Undergoing TKA
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Total Knee Arthroplasty
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Research participants will be randomized to one of three groups (2:2:1 allocation): Immersive VR group Music group Sham VR + usual care control Masking: Single (Outcomes Assessor)Masking Description: Assessors of the Confusion Assessment Method (CAM) and Montreal Cognitive Assessment (MoCA) will be blinded to group assignment.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Both males and females
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. ...
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.
Tracking Information
- NCT #
- NCT04748549
- Collaborators
- Israel-United States Binational Industrial Research and Development Foundation
- XRHealth
- Investigators
- Principal Investigator: Brian P O'Gara, MD,MPH Beth Israel Deaconess Medical Center
Get Well Soon