Intraoperative VR for Older Patients Undergoing TKA

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT04748549
Status
Recruiting
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Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

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 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.
  • Sham Virtual Reality Experience — OTHER
    Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.

Study Details

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.

Key Dates

Start date
Apr 11, 2022
Status verified
Jun 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
131 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

Intraoperative Propofol Dose [ Time Frame: Duration of the procedure, on average 1 to 3 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Brian P. O'Gara, MD, MPH
[email protected]
617-754-3189
Brian O'Gara, MD, MPH (PRINCIPAL_INVESTIGATOR)

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