Total Knee Arthroplasty
Conditions
Keywords
Virtual Reality
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 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.
Interventions
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.
OTHERImmersive 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.
OTHERSham Virtual Reality Experience
Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.
Sponsors
Beth Israel Deaconess Medical Center
Israel-United States Binational Industrial Research and Development Foundation
XRHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors of the Confusion Assessment Method (CAM) and Montreal Cognitive Assessment (MoCA) will be blinded to group assignment.
Intervention model description
Research participants will be randomized to one of three groups (2:2:1 allocation): 1. Immersive VR group 2. Music group 3. Sham VR + usual care control The first 6 patients enrolled will be assigned to the VR group for the purposes of a pilot phase with the objective of identifying and refining any issues with the intervention. Data for these patients will not be included in the statistical analysis.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Propofol Dose | Duration of the procedure, on average 1 to 3 hours | Total propofol dose (mg/kg/min) administered intraoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative and Postoperative Opioids | Duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively | Total intraoperative and postoperative opioid equivalent doses administered |
| Intraoperative Anesthesia Maneuvers | Duration of the procedure, on average 1 to 3 hours | Assessment of intraoperative vital signs and anesthesia maneuvers potentially related to over-sedation (i.e. airway interventions, use of airway assist devices, conversion to general anesthesia) |
| Length of PACU stay | Duration of the patient's stay in the post anesthesia care unit, on average 1 to 5 hours | The length of the patients stay in the Post Anesthesia Care Unit. |
| Postoperative Pain | Measured on postoperative day zero and one, starting with PACU scores | Clinically documented pain scores will be recorded on a scale from 0 (best outcome) to 10 (worst outcome). Using this numeric rating scale, patients will be asked to describe both the maximum and average level of pain |
| Satisfaction with Anesthesia | Within an hour of admission to the postoperative anesthesia care unit | Patients will rate their overall satisfaction with their perioperative anesthesia care using the Iowa Satisfaction with Anesthesia Scale. They will also be asked to rate their satisfaction with their communication with their anesthesia providers. |
| Satisfaction with Recovery | Postoperative day one | Patients will rate their overall satisfaction with their recovery from surgery using the QOR15. Additionally, patients will be asked how frequently they find themselves reacting to pain. |
| Postoperative Delirium | Measured daily on each postoperative day, starting on postoperative day 1 until postoperative day 7. | A member of the research staff will meet with the patient and complete the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) to assess the incidence of postoperative delirium. |
| Delayed Cognitive Recovery and Postoperative Neurocognitive Disorder | Assessment will take place on day of enrollment and then at one week (+/- 48 hours) and one month postoperatively (+/- 7 days). | Cognitive function will be assessed using the telephonic version of the Montreal Cognitive Assessment (MoCA). |
| Assessment of Knee Pain and Function | Assessments will take place within 7 days of the initial clinic visit and within 7 days of the initial postoperative clinic visit, typically one month after surgery. | As part of standard pre and post TKA assessment, patients will be administered the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement Patient-Reported Outcome Measures (KOOS-JR PROM) to assess the degree of limitation in activity and pain from their knee ailment. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian P O'Gara, MD,MPH
Beth Israel Deaconess Medical Center
Outcome results
None listed