RECRUITING

Intraoperative VR for Older Patients Undergoing TKA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Intraoperative Virtual Reality for Older Patients Undergoing Total Knee Arthroplasty

Quick Facts

Study Start:2022-04-11
Study Completion:2024-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04748549

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients age 60 or older undergoing primary total knee replacement surgery at BIDMC and receiving spinal/regional anesthesia
  1. * Complex or revision surgeries
  2. * Patients scheduled for "same day" TKA
  3. * Open wounds or active infection of the face or eye area
  4. * History of seizures or other symptom linked to an epileptic condition
  5. * Patients who plan to wear hearing aids during the procedure
  6. * Patients with a pacemaker or other implanted medical device
  7. * Droplet or airborne precautions (as determined by local infection control policy)
  8. * Non-English speaking or Non-Spanish speaking
  9. * Patients booked to receive general anesthesia
  10. * Moderate to severe dementia
  11. * MoCA \<10 (this test will be administered on Day of Enrollment)

Contacts and Locations

Study Contact

Brian P O'Gara, MD,MPH
CONTACT
617-754-3189
bpogara@bidmc.harvard.edu
Anna Fratello, B.S.
CONTACT
afratell@bidmc.harvard.edu

Principal Investigator

Brian P O'Gara, MD,MPH
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Brian P O'Gara, MD,MPH, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-11
Study Completion Date2024-12-30

Study Record Updates

Study Start Date2022-04-11
Study Completion Date2024-12-30

Terms related to this study

Keywords Provided by Researchers

  • Virtual Reality

Additional Relevant MeSH Terms

  • Total Knee Arthroplasty