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

NCT ID: NCT04469881

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-24
• Study Completion Date: 2023-08-03

Brief Summary

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.

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).

Conditions

Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual Reality

Wear VR glasses and watch movies during surgery

Group Type: EXPERIMENTAL

VR

Intervention Type: BEHAVIORAL

Participants will be asked to do the following things:

1. Wear VR goggles for the duration of the surgery

2. Answer questions about their experience with the VR goggles

3. 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

Interventions

VR

Participants will be asked to do the following things:

1. Wear VR goggles for the duration of the surgery

2. Answer questions about their experience with the VR goggles

3. 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bryant Tran, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20017126

Identifier Type: -

Identifier Source: org_study_id