Demonstrate Effectiveness of Virtual Simulator in Improving OR PerformanceNCT06917183
Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB)
A study testing Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator in people with Demonstrate Effectiveness of Virtual Simulator in Improving OR Performance, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The goal of this study is to evaluate the current use of Operating Room Black Box (ORBB)data in order to develop simulation-based training that improves intraoperative outcomes and safety, and to assess barriers and facilitators to its implementation. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Demonstrate Effectiveness of Virtual Simulator in Improving OR Performance
- What is being tested?
- Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- OR service with a minimum of 5 years of experience that includes surgeons, residents, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists
Who cannot join
- OR team members (surgeons, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists) with less than 5 years of experience
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT southwestern Medical Center
Dallas, Texas, 75390
Ganesh Sankaranarayanan, PhD, 2067347458, Ganesh.Sankaranarayanan@UTSouthwestern.edu
ganesh.sankaranarayanan@utsouthwestern.edu
About this study
The goal of this study is to evaluate the current use of Operating Room Black Box (ORBB)data in order to develop simulation-based training that improves intraoperative outcomes and safety, and to assess barriers and facilitators to its implementation.
There are 3 Aims for this study that the investigator will test, but the Aim that is the interventional portion of this study is only reported here in Aim 2 - Establish the validity and effectiveness of high-fidelity immersive virtual simulation-based training in improving operating room quality and safety.
Read the detailed description
The study will use a mixed within and between subjects' design with two groups - control, and simulation. Due to the dedicated time needed to enroll and complete the sessions along with the need for complete novice subjects, the investigator will recruit medical students at UT Southwestern Medical Center (UTSW) from all years for the simulation group. For the Control group, the investigator will recruit participants from our OR team with a minimum of 5 years of experience at Clements University Hospital (CUH) consisting of surgeons, residents, scrub techs, circulating nurses, anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs) or first assists. Subjects will be randomized into either a control group (didactic) or experimental group (didactic with virtual simulation training). Pre-test: Both groups will take a knowledge assessment test (Multiple choice) that measures baseline knowledge in performing surgical safety checklist. Immediately after that, the participants will be asked to perform the surgical safety checklist once on the simulator. For uniform standard, all participants will choose the role of a surgeon. Both groups will then complete an online introductory module on surgical safety checklists that will be specifically created for use at UTSW. Subjects in the experimental group will then practice on the simulator for 8 sessions with each session not exceeding an hour. The 8 sessions will be completed within three weeks of the pre-test. Deliberate practice will be used to achieve satisfactory scores in the training. A total of 3 scenarios, which will be selected from expert inputs and align with institute priority, will be selected for the training. Post-test: At the end of three weeks, subjects from both groups will once again take the online knowledge test followed by performing the checklists on the simulator. Transfer test: One week after post-test, subjects from both groups will perform surgical safety checklists in a simulated operating room at the UTSW Simulation Center to assess predictive validity. For other team members during the transfer test, the investigator will use the research team and volunteers from the surgical service team. The transfer test performance will be videotaped for assessment.
- Being tested
- Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator
- Keywords
- Virtual Reality, Simulation, OR Team Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training SimulatorOther
Training for performing surgical safety checklist for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Control | No intervention | Group 1 participants will not receive any additional training except for instutionally mandated training |
| Group 2: Simulation | Experimental | Group 2 will practice on the simulator one session every day for 4 weeks. Receives: Other: Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator |
| Group 3: Simulation with repeated reinforcement | Experimental | Group 3 participants will practice on the simulator one session every day for 4 weeks and will continue to practice on the simulator once per week for an additional two months to a total of 8 sessions. Receives: Other: Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in surgical safety checklist performance at 1 month post intervention
Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB
Measured: Baseline, at one month post intervention
Change in surgical safety checklist performance at 3 months post intervention
Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB
Measured: Baseline, at 3 months post intervention
Change in surgical safety checklist performance at 5 months post intervention
Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB
Measured: Baseline, at 5 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start1 Feb 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Demonstrate Effectiveness of Virtual Simulator in Improving OR PerformanceStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- An immersive virtual reality simulator designed to teach how to properly perform surgical safety checklist.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Ganesh Sankaranarayanan, University of Texas Southwestern Medical Center
- Investigators
- Ganesh Sankaranarayanan, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917183
- Sponsor's protocol ID
- STU-2024-0975
- Other IDs
- AHRQ
- Status last verified
- May 2026
- First submitted
- 31 Mar 2025
- Last updated
- 27 May 2026
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB)
- ClinicalTrials.gov ID
- NCT06917183
- Acronym / sponsor ID
- STU-2024-0975
- Keywords
- Virtual Reality, Simulation, OR Team Performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 8 Apr 2025 (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 goal of this study is to evaluate the current use of Operating Room Black Box (ORBB)data in order to develop simulation-based training that improves intraoperative outcomes and safety, and to assess barriers and facilitators to its implementation.
There are 3 Aims for this study that the investigator will test, but the Aim that is the interventional portion of this study is only reported here in Aim 2 - Establish the validity and effectiveness of high-fidelity immersive virtual simulation-based training in improving operating room quality and safety.
Detailed description
The study will use a mixed within and between subjects' design with two groups - control, and simulation. Due to the dedicated time needed to enroll and complete the sessions along with the need for complete novice subjects, the investigator will recruit medical students at UT Southwestern Medical Center (UTSW) from all years for the simulation group. For the Control group, the investigator will recruit participants from our OR team with a minimum of 5 years of experience at Clements University Hospital (CUH) consisting of surgeons, residents, scrub techs, circulating nurses, anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs) or first assists. Subjects will be randomized into either a control group (didactic) or experimental group (didactic with virtual simulation training). Pre-test: Both groups will take a knowledge assessment test (Multiple choice) that measures baseline knowledge in performing surgical safety checklist. Immediately after that, the participants will be asked to perform the surgical safety checklist once on the simulator. For uniform standard, all participants will choose the role of a surgeon. Both groups will then complete an online introductory module on surgical safety checklists that will be specifically created for use at UTSW. Subjects in the experimental group will then practice on the simulator for 8 sessions with each session not exceeding an hour. The 8 sessions will be completed within three weeks of the pre-test. Deliberate practice will be used to achieve satisfactory scores in the training. A total of 3 scenarios, which will be selected from expert inputs and align with institute priority, will be selected for the training. Post-test: At the end of three weeks, subjects from both groups will once again take the online knowledge test followed by performing the checklists on the simulator. Transfer test: One week after post-test, subjects from both groups will perform surgical safety checklists in a simulated operating room at the UTSW Simulation Center to assess predictive validity. For other team members during the transfer test, the investigator will use the research team and volunteers from the surgical service team. The transfer test performance will be videotaped for assessment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- An immersive virtual reality simulator designed to teach how to properly perform surgical safety checklist.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Control | No intervention | –Group 1 participants will not receive any additional training except for instutionally mandated training |
| Group 2: Simulation | Experimental | Other: Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training SimulatorGroup 2 will practice on the simulator one session every day for 4 weeks. |
| Group 3: Simulation with repeated reinforcement | Experimental | Other: Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training SimulatorGroup 3 participants will practice on the simulator one session every day for 4 weeks and will continue to practice on the simulator once per week for an additional two months to a total of 8 sessions. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- OR service with a minimum of 5 years of experience that includes surgeons, residents, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists
Key exclusion criteria (1 listed)
- OR team members (surgeons, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists) with less than 5 years of experience
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 |
|---|---|---|
| Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training SimulatorTraining for performing surgical safety checklist for a period of 4 weeks. | Other | Group 2: Simulation, Group 3: Simulation with repeated reinforcement |
Primary outcome
Change in surgical safety checklist performance at 1 month post intervention
Time frame: Baseline, at one month post intervention
Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB
Change in surgical safety checklist performance at 3 months post intervention
Time frame: Baseline, at 3 months post intervention
Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB
Change in surgical safety checklist performance at 5 months post intervention
Time frame: Baseline, at 5 months post intervention
Change in surgical safety checklist performance is assessed using the Compliance, engagement and quality scores computed automatically using the ORBB
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- 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.
Ganesh Sankaranarayanan, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training using the Immersive Multi- player Virtual Surgical Safety Checklist Training Simulator in people with Demonstrate Effectiveness of Virtual Simulator in Improving OR Performance, run by University of Texas Southwestern Medical Center 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ganesh Sankaranarayanan, PhD (2067347458, Ganesh.Sankaranarayanan@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in surgical safety checklist performance at 1 month post intervention (time frame: Baseline, at one month post intervention). The study lists 3 primary outcomes in all. 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 27 May 2026.