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Completed

NCT Number: NCT04748549

Intraoperative VR for Older Patients Undergoing TKA

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Intraoperative Propofol Dose

    Time frame: Duration of the procedure, on average 1 to 3 hours

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

Secondary outcomes

  1. Intraoperative and Postoperative Opioids

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

    Total intraoperative and postoperative opioid equivalent doses administered

  2. Intraoperative Anesthesia Maneuvers

    Time frame: 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)

  3. Length of PACU stay

    Time frame: 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.

  4. Postoperative Pain

    Time frame: 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

  5. Satisfaction with Anesthesia

    Time frame: 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.

  6. Satisfaction with Recovery

    Time frame: 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.

  7. Postoperative Delirium

    Time frame: 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.

  8. Delayed Cognitive Recovery and Postoperative Neurocognitive Disorder

    Time frame: 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).

  9. Assessment of Knee Pain and Function

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Israel-United States Binational Industrial Research and Development Foundation
  • XRHealth

Registry information

Official study title

Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2021
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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