- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404010
Virtual Reality vs Technical Video in Surgical Training
Effectiveness of Immersive Virtual Reality Training Compared to Instructional Technical Surgical Video: A Randomized Controlled Trial
The use of instructional technical surgical videos is common in orthopaedic education. Many residents have used instructional technical surgical training videos prior to medical school, as well as during their residency program, and at instructional courses. The use of instructional technical surgical videos and multimedia is considered an adjunctive training method for orthopaedic residents to learn operative procedures.
Immersive virtual reality (iVR) is increasingly used in surgical education. Recently, iVR has shown transfer of skill training in orthopaedics. The continued study of the effectiveness of iVR training in orthopaedic education could benefit new competency based orthopaedics residency programs.
The purpose of this study is to compare the effectiveness of instructional technical surgical video training to immersive iVR training for teaching technical skills of reverse total shoulder arthroplasty. Our hypothesis was that iVR improved learning effectiveness compared to standard technical surgical video. Secondary objectives include validating a virtual reality ratings scale through correlation to real-world performance.
We proposed a randomized, blinded intervention-control trial directly comparing immersive iVR versus technical surgical instructional video training in the teaching of reverse shoulder arthroplasty in senior residents, learning at the 2020 annual Canadian Shoulder and Elbow Society meeting.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The use of instructional technical surgical videos is common in orthopaedic education. Many residents have used instructional technical surgical training videos prior to medical school, as well as during their residency program, and at instructional courses. The use of instructional technical surgical videos and multimedia is considered an adjunctive training method for orthopaedic residents to learn operative procedures.
Immersive virtual reality (iVR) is increasingly used in surgical education. Recently, iVR has shown transfer of skill training in orthopaedics. The continued study of the effectiveness of iVR training in orthopaedic education could benefit new competency based orthopaedics residency programs.
The purpose of this study is to compare the effectiveness of instructional technical surgical video training to immersive iVR training for teaching technical skills of reverse total shoulder arthroplasty. Our hypothesis was that iVR improved learning effectiveness compared to standard technical surgical video. Secondary objectives include validating a virtual reality ratings scale through correlation to real-world performance, and to determine efficiency of learning in both groups.
Currently, technical surgical instructional videos are pervasive in orthopaedic teaching education. Immersive VR, another form of teaching, is increasingly being used in surgical education. The production of an immersive VR suite with tactile and user metric feedback may be an advance over current bench top simulator technology, allowing for greater immersion and interaction, leading to better understanding of surgical planning and implementation. The development of this technology could provide trainees with immersive levels of training not previously seen, with improved learning of technical skills over media such as manufacturer technical documents. The effectiveness of training and efficiency of training of the novel immersive VR training systems need to be evaluated as they are increasingly incorporated into competency based, contemporary residency education.
We proposed a randomized, blinded intervention-control trial directly comparing immersive iVR versus technical surgical instructional video training in the teaching of reverse shoulder arthroplasty in senior (fourth and fifth year) residents, learning at the 2020 annual Canadian Shoulder and Elbow Society meeting.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4M9
- The University of Ottawa Skills and Simulation Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Senior residents (4th and 5th year residents) attending 2020 CSES course
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Immersive Virtual Reality
Participants randomized to the immersive virtual reality (iVR) study arm, considered the "intervention group" will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).
|
Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience.
The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure.
Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel.
Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.
|
OTHER: Surgical Video
Participants randomized to the standard video study arm, considered the "control group" will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.
|
Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Structured Assessment of Technical Skills (OSATS)
Time Frame: During surgery up until immediately after surgery.
|
The Objective Structured Assessment of Technical Skills (OSATS) outcome measure is a validated assessment tool used for grading overall technical ability during surgery.
This checklist contains 27 items, in which an assessor will mark off whether the task was completed successfully or not.
For each item done correctly, it is worth 1 point.
For each item done incorrectly, no point is awarded.
All points are totalled for a maximum possible score of 27 points (minimum score of 0 and maximum score of 27).
A higher score indicates a better outcome.
|
During surgery up until immediately after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Ratings Scale (GRS)
Time Frame: During surgery up until immediately after surgery.
|
The Global Ratings Scale (GRS) is a validated assessment tool used for grading operative performance.
The GRS contains 7 categories: respect for tissue, time and motion, instrument handling, knowledge of instruments, flow of operation, use of assistants, and knowledge of specific procedure.
Each category is graded using a 5-point Likert type scale, a higher number indicates a better outcome, with a maximum of 5 points per category.
Each categorical score is totalled for a maximum overall score of 35 points (minimum score of 0 and maximum score of 35).
A higher score indicates a better outcome.
|
During surgery up until immediately after surgery.
|
Transfer of Training (ToT)
Time Frame: immediately after surgery.
|
Transfer of Training (ToT) outcome informs how much skill is gained in the iVR group compared to the control performance.
This is measured using an equation.
ToT equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete surgical procedure (for those in instructional video group).
The outcome is presented as a cumulative ratio, and a numerical value is provided.
A higher number indicates a better outcome.
For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.
|
immediately after surgery.
|
Transfer Effectiveness Ratio (TER)
Time Frame: Immediately before surgery up immediately after surgery.
|
Transfer Effectiveness Ratio (TER) outcomes informs on the skill comparison relative to the control, on real world training reduction times.
TER equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete the iVR training.
The outcome is presented as a cumulative ratio, and a numerical value is provided.
A higher number, indicates a better outcome.
For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.
|
Immediately before surgery up immediately after surgery.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: J Pollock, MD, The Ottawa Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20200008-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgical Training
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Clarunis - Universitäres Bauchzentrum BaselUniversity of BaselCompleted
-
University of Illinois at ChicagoCompletedVirtual Reality | Surgical TrainingUnited States
-
Unity Health TorontoUnknownSurgical Videos | Pre-operative TrainingCanada
-
Hospital Universitari de BellvitgeHospital General Universitario Gregorio Marañon; Institut d'Investigació Biomèdica... and other collaboratorsRecruitingTraining | Safety | Endoscopic Surgical ProcedureSpain
-
University of TorontoNot yet recruitingVirtual Reality | Surgical Education | Orthopaedic Training
-
University of AarhusCentral Denmark Region; Aalborg University Hospital; TRYG FoundationCompletedSurgical TrainingDenmark
-
Copenhagen Academy for Medical Education and SimulationUnknownSurgical Procedure, Unspecified | Simulation Training | Education, Medical | Learning | Humans | Problem-Based Learning | Clinical CompetenceDenmark
-
Duke UniversityUniversity of Pittsburgh Medical CenterRecruitingGeneral Health Education | Coping Skills Training for Persistent Post-Surgical PainUnited States
Clinical Trials on Immersive Virtual Reality
-
I.R.C.C.S. Fondazione Santa LuciaRecruitingStroke | Neglect, HemispatialItaly
-
Acibadem UniversityKartal Dr. Lütfi Kirdar City HospitalCompletedRheumatoid Arthritis | Chronic Pain | Virtual RealityTurkey
-
Kessler FoundationCompletedTraumatic Brain InjuryUnited States
-
Groupe Hospitalier Paris Saint JosephActive, not recruitingChronic Low-back PainFrance
-
Sheffield Hallam UniversityMedical Research CouncilCompletedUpper Extremity Fracture | Burn; Arm | Exostosis of Elbow | Burn ScaldUnited Kingdom
-
Tufts UniversityTufts Clinical and Translational Science InstituteCompleted
-
Copenhagen Academy for Medical Education and SimulationCompleted
-
Tufts UniversityBrigham and Women's HospitalWithdrawnChronic PainUnited States
-
Loma Linda UniversityCompletedComplex Regional Pain Syndromes | Neuropathic Pain | Neuropathy | Phantom Limb PainUnited States
-
InHealth GroupUnknown