Intraoperative VR for Older Patients Undergoing TKA

Beth Israel Lahey Health

Status: Enrolling

Conditions: Total Knee Arthroplasty

Treatments: Other: Sham Virtual Reality Experience; Other: Virtual Reality Immersive Relaxation; Other: Immersive Audio Experience

Study type: Interventional

Funder types: Other

Identifiers

NCT04748549

2020P001176

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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131 participants in 3 patient groups

Immersive VR group

Experimental group

Description:

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.

Treatment:

Other: Virtual Reality Immersive Relaxation

Music group

Active Comparator group

Description:

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.

Treatment:

Other: Immersive Audio Experience

Sham VR + Usual Care Control Group

Sham Comparator group

Description:

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.

Treatment:

Other: Sham Virtual Reality Experience