Intraoperative VR for Older Patients Undergoing TKA

NCT04748549 | Recruiting DMC

• 1 other identifier: 2020P001176
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Intraoperative Propofol Dose

  Total propofol dose (mg/kg/min) administered intraoperatively

  Duration of the procedure, on average 1 to 3 hours

Secondary Outcomes (9)

• Intraoperative and Postoperative Opioids

  Duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively

• Intraoperative Anesthesia Maneuvers

  Duration of the procedure, on average 1 to 3 hours

• Length of PACU stay

  Duration of the patient's stay in the post anesthesia care unit, on average 1 to 5 hours

• Postoperative Pain

  Measured on postoperative day zero and one, starting with PACU scores

• Satisfaction with Anesthesia

  Within an hour of admission to the postoperative anesthesia care unit

Study Arms (3)

Immersive VR group

EXPERIMENTAL

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.

Other: Virtual Reality Immersive Relaxation

Music group

ACTIVE COMPARATOR

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.

Other: Immersive Audio Experience

Sham VR + Usual Care Control Group

SHAM COMPARATOR

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.

Other: Sham Virtual Reality Experience

Interventions

Virtual Reality Immersive Relaxation OTHER

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 VR group

Immersive Audio Experience OTHER

A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient.

Music group

Sham Virtual Reality Experience OTHER

Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.

Sham VR + Usual Care Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Israel-United States Binational Industrial Research and Development Foundation: collaborator
• XRHealth: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39695824 DERIVED

Study Officials

• Brian P O'Gara, MD,MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian P O'Gara, MD,MPH

CONTACT

617-754-3189; bpogara@bidmc.harvard.edu

Anna Fratello, B.S.

CONTACT

afratell@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors of the Confusion Assessment Method (CAM) and Montreal Cognitive Assessment (MoCA) will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesia

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 10, 2021
• Study Start: April 11, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)