SurgeryNCT04469881
Netflix Streaming Services in the Operating Room During Total Knee Replacement - a Feasibility Study
A study testing VR in people with Surgery, run by Virginia Commonwealth University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2020to 3 Aug 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing a primary elective total knee replacement by one of the orthopedic joint surgeons at Virginia Commonwealth University Medical Center
- 18 years of age or older
- eligible for spinal anesthesia
- mentally capable of understanding instructions on how to request anesthesia medication
Who cannot join
- identified as a member of regulated vulnerable population
- ineligibility for spinal anesthesia
- morbid obesity (body mass index greater than 40)
- allergy to propofol or midazolam
- pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours (over 60 morphine miligram equivalents per day)
- daily benzodiazepine consumption
- history of alcohol or recreational drug abuse
- hearing or visually impaired individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this 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.
Read the 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
- Being tested
- VR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Wear VR glasses and watch movies during surgery Receives: Behavioral: VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation requirement
Micrograms of propofol per kilogram per minute
Measured: approximately 2 hours
Secondary outcomes (3)
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.
Measured: 24 hours
Opioid consumption
Total miligram morphine equivalents of opioid pain medication administered during 24 hours post surgery.
Measured: 24 hours
Time to first opioid request
Time in minutes between leaving the operating room and administration of first oral opioid.
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start24 Nov 2020
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Why it stopped: Lost research staff - unable to enroll until new research staff is hired.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bryant Tran, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469881
- Sponsor's protocol ID
- HM20017126
- Status last verified
- Aug 2023
- First submitted
- 9 Jul 2020
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Netflix Streaming Services in the Operating Room During Total Knee Replacement - a Feasibility Study
- ClinicalTrials.gov ID
- NCT04469881
- Acronym / sponsor ID
- HM20017126
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lost research staff - unable to enroll until new research staff is hired.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 14 Jul 2020 (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 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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: VRWear VR glasses and watch movies during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergoing a primary elective total knee replacement by one of the orthopedic joint surgeons at Virginia Commonwealth University Medical Center
- 18 years of age or older
- eligible for spinal anesthesia
- mentally capable of understanding instructions on how to request anesthesia medication
Key exclusion criteria (8 listed)
- identified as a member of regulated vulnerable population
- ineligibility for spinal anesthesia
- morbid obesity (body mass index greater than 40)
- allergy to propofol or midazolam
- pre-operative daily opioid consumption of more than 10 mg oxycodone every 6 hours (over 60 morphine miligram equivalents per day)
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 |
|---|---|---|
| VRParticipants 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 | Behavioural | Virtual Reality |
Primary outcome
Sedation requirement
Time frame: approximately 2 hours
Micrograms of propofol per kilogram per minute
3 secondary outcomes
Participant pain rating
Time frame: 24 hours
Opioid consumption
Time frame: 24 hours
Time to first opioid request
Time frame: up to 24 hours
Results and safety
The study was stopped early (reason given: Lost research staff - unable to enroll until new research staff is hired.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- 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.
Bryant Tran, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR in people with Surgery, run by Virginia Commonwealth University 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Aug 2023. 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. 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 was stopped early (reason given: Lost research staff - unable to enroll until new research staff is hired.). Results are not available in the source record.
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?
Sedation requirement (time frame: approximately 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2023.