Virtual Simulation-Based Training for Surgical Simulation

Overseen By Ganesh Sankaranarayanan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Less than 5 years experience

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual simulation training program to determine its impact on safety and outcomes in the operating room. Participants will use an immersive multi-player virtual surgical safety checklist training simulator, with varying practice frequencies among groups. The goal is to discover if this training improves surgical safety and efficiency. The trial seeks experienced operating room professionals, such as surgeons, nurses, or anesthesiologists, with at least 5 years of experience. As an unphased trial, it offers a unique opportunity for professionals to contribute to innovative training methods that could enhance surgical safety and efficiency.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this virtual simulation-based training is safe for surgical simulation?

Research has shown that immersive virtual reality (iVR) training is generally easy for people to handle. Studies have found that using iVR for surgical training can enhance skills like stitching wounds without causing harm. For example, one study found that participants using iVR achieved significantly better training scores, suggesting it is a safe and effective learning method.

Additionally, immersive virtual simulations are non-invasive, as they do not involve any physical procedures or medications, reducing the risk of side effects. Participants mainly interact with virtual environments, so the primary concerns might be motion sickness or eye strain, similar to playing video games. However, these issues are usually mild and temporary.

Overall, immersive virtual reality has proven to be a safe method for training in the medical field, with little to no serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to enhance surgical training using immersive, multi-player virtual simulation. Unlike traditional methods, which often rely on real-life practice or video-based learning, this approach offers a dynamic, interactive environment where surgeons can repeatedly practice procedures in a risk-free setting. The simulator's ability to provide repeated reinforcement and immediate feedback aims to significantly improve surgical skills and safety. This innovative training method could lead to more competent surgeons and better patient outcomes by bridging the gap between theoretical knowledge and practical application.

What evidence suggests that this virtual simulation-based training is effective for improving operating room quality and safety?

Research has shown that virtual reality training can enhance surgical skills and teamwork. One study found that this training significantly improved wound-stitching abilities, essential for surgery. Another study demonstrated that it also enhances communication and teamwork skills, crucial for operating room safety. In this trial, participants in Group 2 and Group 3 will use the Immersive Multi-player Virtual Surgical Safety Checklist Training Simulator to practice these skills. This training employs 360° videos to create a realistic experience, allowing participants to practice safely. These findings suggest that virtual reality training can improve overall performance and safety in the operating room. ^{1 2 3 4 6}

Who Is on the Research Team?

Ganesh Sankaranarayanan, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals involved in surgical operations, likely healthcare professionals like surgeons and operating room staff. The goal is to improve their skills using a virtual reality simulation that mimics real-life surgery scenarios.

Inclusion Criteria

OR service with a minimum of 5 years of experience that includes surgeons, residents, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists

Exclusion Criteria

OR team members (surgeons, scrub techs, circulating nurses, anesthesiologists, CRNAs or first assists) with less than 5 years of experience

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-test and Initial Training

Participants take a knowledge assessment test and perform the surgical safety checklist on the simulator. Experimental group practices on the simulator for 8 sessions over three weeks.

3 weeks

8 sessions (in-person)

Post-test and Transfer Test

Participants take a post-test and perform surgical safety checklists in a simulated operating room to assess predictive validity.

1 week

1 session (in-person)

Extended Simulation Training

Group 3 participants continue to practice on the simulator once per week for an additional two months.

2 months

8 sessions (in-person)

Follow-up

Participants are monitored for changes in surgical safety checklist performance at 1, 3, and 5 months post intervention.

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Immersive Multi-player Virtual Surgical Safety Checklist Training Simulator

Trial Overview

The study tests the effectiveness of an Immersive Multiplayer Virtual Surgical Safety Checklist Training Simulator. It aims to see if this high-tech training can make surgeries safer and improve overall quality in the operating room.

How Is the Trial Designed?

Group I: Group 3: Simulation with repeated reinforcement Experimental Treatment 1 Intervention

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.

Group II: Group 2: Simulation Experimental Treatment 1 Intervention

Group 2 will practice on the simulator one session every day for 4 weeks.

Group III: Group 1: Control Active Control 1 Intervention

Group 1 participants will not receive any additional training except for instutionally mandated training

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

The STEPS program, developed at Louisiana State University Health Sciences Center, uses high-fidelity human patient simulators in a mobile mock operating room to train surgical teams, enhancing patient safety through realistic simulations.

Team performance was evaluated through direct observation and a 360-degree assessment, allowing team members to reflect on their own and each other's communication skills, which is crucial for improving teamwork in real clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial implementation of mixed reality simulation targeting teamwork and patient safety. Kozmenko, V., Paige, J., Chauvin, S.[2008]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06917183

Developing Strategies for Implementation and Use of the ...

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 ...

2.

withpower.com

withpower.com/trial/phase-demonstrate-effectiveness-of-virtual-simulator-in-improving-or-performance-1-2027-7bbed

Virtual Simulation-Based Training for Surgical Simulation

This treatment is unique because it uses immersive multi-player virtual reality to train surgical teams, focusing on both technical and nontechnical skills, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11224887/

The impact of simulation-based training in medical education

This article explores the impact of SBT, tracing its historical development and examining the various types of simulations utilized today, ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2405844024077235

Immersive virtual reality as a surgical training tool: A cohort ...

This study demonstrates that iVR training using real-world 360° instructional recordings produced significantly greater training gains in suturing scores and ...

5.

dl.acm.org

dl.acm.org/doi/10.1145/2656719.2656725

A Natural and Immersive Virtual Interface for the Surgical ...

A Natural and Immersive Virtual Interface for the Surgical Safety Checklist Training ... Simulation-based trial of surgical-crisis checklists. New England ...

6.

researchgate.net

researchgate.net/publication/353327087_Immersive_Virtual_Reality_for_Surgical_Training_A_Systematic_Review

Immersive Virtual Reality for Surgical Training

This systematic review examines the current literature on the effectiveness of iVR for surgical skills acquisition in medical students, residents, and staff ...