Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
131 participants
INTERVENTIONAL
2022-04-11
2027-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
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.
Sham Virtual Reality Experience
Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.
Interventions
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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.
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.
Sham Virtual Reality Experience
Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.
Eligibility Criteria
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Inclusion Criteria
* English or Spanish speaking patients
Exclusion Criteria
* 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)
60 Years
ALL
No
Sponsors
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Israel-United States Binational Industrial Research and Development Foundation
UNKNOWN
XRHealth
UNKNOWN
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Brian O'Gara
Assistant Professor of Anaesthesia
Principal Investigators
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Brian P O'Gara, MD,MPH
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Espinosa-Leon JP, Mathura R, Chen G, Joseph M, Sadhwani T, Beydoun N, Hernandez ER, Riley T, Kunze LJ, Goodspeed V, O'Gara BP. Intraoperative virtual reality for older patients undergoing total knee arthroplasty: study protocol for a randomized clinical trial. Trials. 2024 Dec 18;25(1):830. doi: 10.1186/s13063-024-08551-6.
Other Identifiers
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2020P001176
Identifier Type: -
Identifier Source: org_study_id
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