Total Knee ArthroplastyNCT04748549
Intraoperative VR for Older Patients Undergoing TKA
A study testing Virtual Reality Immersive Relaxation and Immersive Audio Experience in people with Total Knee Arthroplasty, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Virtual Reality Immersive Relaxation and Immersive Audio Experience
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2022to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia
- English or Spanish speaking patients
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
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.
Read the detailed 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Virtual Reality Immersive Relaxation, Immersive Audio Experience, Sham Virtual Reality Experience
- Keywords
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Immersive RelaxationOther
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 ExperienceOther
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 ExperienceOther
Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Sham Virtual Reality Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Propofol Dose
Total propofol dose (mg/kg/min) administered intraoperatively
Measured: Duration of the procedure, on average 1 to 3 hours
Secondary outcomes (9)
Intraoperative and Postoperative Opioids
Total intraoperative and postoperative opioid equivalent doses administered
Measured: Duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively
Intraoperative Anesthesia Maneuvers
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)
Measured: Duration of the procedure, on average 1 to 3 hours
Length of PACU stay
The length of the patients stay in the Post Anesthesia Care Unit.
Measured: Duration of the patient's stay in the post anesthesia care unit, on average 1 to 5 hours
Postoperative Pain
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
Measured: Measured on postoperative day zero and one, starting with PACU scores
Satisfaction with Anesthesia
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.
Measured: Within an hour of admission to the postoperative anesthesia care unit
Satisfaction with Recovery
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.
Measured: Postoperative day one
Postoperative Delirium
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.
Measured: Measured daily on each postoperative day, starting on postoperative day 1 until postoperative day 7.
Delayed Cognitive Recovery and Postoperative Neurocognitive Disorder
Cognitive function will be assessed using the telephonic version of the Montreal Cognitive Assessment (MoCA).
Measured: Assessment will take place on day of enrollment and then at one week (+/- 48 hours) and one month postoperatively (+/- 7 days).
Assessment of Knee Pain and Function
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start11 Apr 2022
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Israel-United States Binational Industrial Research and Development Foundation, XRHealth
- Responsible party
- Principal investigator, Brian O'Gara, Beth Israel Deaconess Medical Center
- Investigators
- Brian P O'Gara, MD,MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748549
- Sponsor's protocol ID
- 2020P001176
- Status last verified
- May 2026
- First submitted
- 29 Jan 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39695824
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04748549
- Acronym / sponsor ID
- 2020P001176
- Conditions
- Total Knee Arthroplasty
- Keywords
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Israel-United States Binational Industrial Research and Development Foundation, XRHealth
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immersive VR group | Experimental | Other: Virtual Reality Immersive RelaxationPatients 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. |
| Music group | Active comparator | Other: Immersive Audio ExperiencePatients 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 VR + Usual Care Control Group | Sham comparator | Other: Sham Virtual Reality ExperienceSubjects 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia
- English or Spanish speaking patients
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Immersive RelaxationThe 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. | Other | Immersive VR group |
| Immersive Audio ExperienceA study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient. | Other | Music group |
| Sham Virtual Reality ExperienceSubjects will wear VR headsets and headphones but will not view any content or listen to any audible content. | Other | Sham VR + Usual Care Control Group |
Primary outcome
Intraoperative Propofol Dose
Time frame: Duration of the procedure, on average 1 to 3 hours
Total propofol dose (mg/kg/min) administered intraoperatively
9 secondary outcomes
Intraoperative and Postoperative Opioids
Time frame: Duration of the procedure, on average 1 to 3 hours, and up until 72-hours postoperatively
Intraoperative Anesthesia Maneuvers
Time frame: Duration of the procedure, on average 1 to 3 hours
Length of PACU stay
Time frame: Duration of the patient's stay in the post anesthesia care unit, on average 1 to 5 hours
Postoperative Pain
Time frame: Measured on postoperative day zero and one, starting with PACU scores
Satisfaction with Anesthesia
Time frame: Within an hour of admission to the postoperative anesthesia care unit
Satisfaction with Recovery
Time frame: Postoperative day one
Postoperative Delirium
Time frame: Measured daily on each postoperative day, starting on postoperative day 1 until postoperative day 7.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 39695824Espinosa-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian P O'Gara, MD,MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Immersive Relaxation and Immersive Audio Experience in people with Total Knee Arthroplasty, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Propofol Dose (time frame: Duration of the procedure, on average 1 to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04748549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.