Netflix Streaming Services in the Operating Room During Total Knee Replacement - a Feasibility Study

The purpose of this research study is to test the safety, tolerability, and effectiveness of watching streamed videos through virtual reality (VR) goggles during surgery.

The results of this study will be used to evaluate whether video-streaming services on VR goggles are worthwhile additions to standard anesthesia care during total knee surgery.

Study Overview

• Status: Terminated
• Conditions: Surgery
• Intervention / Treatment: Behavioral: VR

Detailed Description

Usual anesthetic care for total knee replacement involves intravenous sedation as well as spinal anesthesia. In this study, participants will receive usual care, and in addition, will be asked to wear VR goggles once they arrive in the operating room. Participants will choose from a selection of 10 shows and movies to watch for the duration of the surgery (approximately 2 hours).

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. undergoing a primary elective total knee replacement by one of the orthopedic joint surgeons at Virginia Commonwealth University Medical Center
2. 18 years of age or older
3. eligible for spinal anesthesia
4. mentally capable of understanding instructions on how to request anesthesia medication

Exclusion Criteria:

1. identified as a member of regulated vulnerable population
2. ineligibility for spinal anesthesia
3. morbid obesity (body mass index greater than 40)
4. allergy to propofol or midazolam
5. pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours (over 60 morphine miligram equivalents per day)
6. daily benzodiazepine consumption
7. history of alcohol or recreational drug abuse
8. hearing or visually impaired individuals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Wear VR glasses and watch movies during surgery	Behavioral: VR; Participants will be asked to do the following things: Wear VR goggles for the duration of the surgery; Answer questions about their experience with the VR goggles; Give permission for the researchers to collect information about the anesthesia medications used, pain medications used, and reported pain scores during the surgery and during recovery in the hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation requirement	Micrograms of propofol per kilogram per minute	approximately 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant pain rating	Average pain score measured immediately after surgery and every 4 hours afterwards for 24 hour. Pain will be rated on a 0 to 10 scale with 0 being no pain and 10 being the worst pain imaginable.	24 hours
Opioid consumption	Total miligram morphine equivalents of opioid pain medication administered during 24 hours post surgery.	24 hours
Time to first opioid request	Time in minutes between leaving the operating room and administration of first oral opioid.	up to 24 hours

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Bryant Tran, MD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): August 3, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HM20017126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No