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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04469881
• Other study ID #: HM20017126
• Status: Terminated
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: August 3, 2023

Study information

• Verified date: August 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 3, 2023
• Est. primary completion date: August 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation requirement	Micrograms of propofol per kilogram per minute	approximately 2 hours
Secondary	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
Secondary	Opioid consumption	Total miligram morphine equivalents of opioid pain medication administered during 24 hours post surgery.	24 hours
Secondary	Time to first opioid request	Time in minutes between leaving the operating room and administration of first oral opioid.	up to 24 hours