Surgical TrainingNCT04404010
Virtual Reality vs Technical Video in Surgical Training
A study testing Immersive Virtual Reality and Surgical Technical Instructional Video in people with Surgical Training, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Training
- What is being tested?
- Immersive Virtual Reality and Surgical Technical Instructional Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jan 2020to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Senior residents (4th and 5th year residents) attending 2020 CSES course
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Canada1 site
The University of Ottawa Skills and Simulation Centre
Ottawa, Ontario, K1Y 4M9
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Surgical Training
- Being tested
- Immersive Virtual Reality, Surgical Technical Instructional Video
- Keywords
- Immersive Virtual Reality, Technical Training Video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityOther
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.
Surgical Technical Instructional VideoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality | Active comparator | 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). Receives: Other: Immersive Virtual Reality |
| Surgical Video | Other | 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. Receives: Other: Surgical Technical Instructional Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Structured Assessment of Technical Skills (OSATS)
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.
Measured: During surgery up until immediately after surgery.
Secondary outcomes (3)
Global Ratings Scale (GRS)
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.
Measured: During surgery up until immediately after surgery.
Transfer of Training (ToT)
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.
Measured: immediately after surgery.
Transfer Effectiveness Ratio (TER)
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.
Measured: Immediately before surgery up immediately after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start30 Jan 2020
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical TrainingStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- PrecisionOS Technology
- Responsible party
- Sponsor
- Investigators
- J Pollock, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404010
- Sponsor's protocol ID
- 20200008-01H
- Status last verified
- Sep 2022
- First submitted
- 22 May 2020
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lohre R, Bois AJ, Pollock JW, Lapner P, McIlquham K, Athwal GS, Goel DP. Effectiveness of Immersive Virtual Reality on Orthopedic Surgical Skills and Knowledge Acquisition Among Senior Surgical Residents: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2031217. doi: 10.1001/jamanetworkopen.2020.31217.
PubMed 33369660
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Immersive Virtual Reality Training Compared to Instructional Technical Surgical Video: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04404010
- Acronym / sponsor ID
- 20200008-01H
- Conditions
- Surgical Training
- Keywords
- Immersive Virtual Reality, Technical Training Video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- PrecisionOS Technology
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 27 May 2020 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality | Active comparator | Other: Immersive Virtual RealityParticipants 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). |
| Surgical Video | Other | Other: Surgical Technical Instructional VideoParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Senior residents (4th and 5th year residents) attending 2020 CSES course
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Immersive Virtual RealityParticipants 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 | Immersive Virtual Reality |
| Surgical Technical Instructional VideoParticipants 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. | Other | Surgical Video |
Primary outcome
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.
3 secondary outcomes
Global Ratings Scale (GRS)
Time frame: During surgery up until immediately after surgery.
Transfer of Training (ToT)
Time frame: immediately after surgery.
Transfer Effectiveness Ratio (TER)
Time frame: Immediately before surgery up immediately after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33369660Lohre R, Bois AJ, Pollock JW, Lapner P, McIlquham K, Athwal GS, Goel DP. Effectiveness of Immersive Virtual Reality on Orthopedic Surgical Skills and Knowledge Acquisition Among Senior Surgical Residents: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2031217. doi: 10.1001/jamanetworkopen.2020.31217.
- 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.
J Pollock, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality and Surgical Technical Instructional Video in people with Surgical Training, run by Ottawa Hospital Research Institute at 1 site in Canada.
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: finished, as of the sponsor's last update on 28 Sep 2022. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 5 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Structured Assessment of Technical Skills (OSATS) (time frame: During surgery up until immediately after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04404010, which also lists 1 linked publication.
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 28 Sep 2022.