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Virtual Reality vs Technical Video in Surgical Training

Effectiveness of Immersive Virtual Reality Training Compared to Instructional Technical Surgical Video: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04404010
Enrollment
20
Registered
2020-05-27
Start date
2020-01-30
Completion date
2020-02-01
Last updated
2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Training

Keywords

Immersive Virtual Reality, Technical Training Video

Brief 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. 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.

Interventions

OTHERImmersive Virtual Reality

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.

OTHERSurgical Technical 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.

Sponsors

PrecisionOS Technology
CollaboratorINDUSTRY
Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Senior residents (4th and 5th year residents) attending 2020 CSES course

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Objective Structured Assessment of Technical Skills (OSATS)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.

Secondary

MeasureTime frameDescription
Global Ratings Scale (GRS)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.
Transfer of Training (ToT)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.
Transfer Effectiveness Ratio (TER)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.

Countries

Canada

Participant flow

Pre-assignment details

1 participant was mistakenly consented (error in screening - participant was not a PGY4 or 5) and randomized to immersive virtual reality arm as part of study. After randomization, but prior to study testing we realized the participant was not eligible, therefore they were excluded prior to any further study procedures commenced. 1 additional participant was mistakenly consented (error in screening - participant was not a PGY4 or 5), therefore excluded PRIOR to randomization.

Participants by arm

ArmCount
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). Immersive Virtual Reality: 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.
9
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. Surgical Technical 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.
9
Total18

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyMistakenly enrolled, withdrawn after randomization (did not meet eligibility criteria)10

Baseline characteristics

CharacteristicSurgical VideoTotalImmersive Virtual Reality
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
9 Participants18 Participants9 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Canada
9 participants18 participants9 participants
Sex: Female, Male
Female
3 Participants4 Participants1 Participants
Sex: Female, Male
Male
6 Participants14 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 9
other
Total, other adverse events
0 / 90 / 9
serious
Total, serious adverse events
0 / 90 / 9

Outcome results

Primary

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.

Time frame: During surgery up until immediately after surgery.

ArmMeasureValue (MEAN)
Immersive Virtual RealityObjective Structured Assessment of Technical Skills (OSATS)15.9 score on a scale
Surgical VideoObjective Structured Assessment of Technical Skills (OSATS)9.4 score on a scale
Secondary

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.

Time frame: During surgery up until immediately after surgery.

ArmMeasureValue (MEAN)Dispersion
Immersive Virtual RealityGlobal Ratings Scale (GRS)22.8 Score on a scaleStandard Deviation 8.2
Surgical VideoGlobal Ratings Scale (GRS)22.4 Score on a scaleStandard Deviation 9
Secondary

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.

Time frame: Immediately before surgery up immediately after surgery.

Population: The TER is calculated as a cumulative ratio. There isn't a spread of data for a single instance of training, however, if we had done more repetitions then we would have incremental values for each. Therefore, the single numerical value of TER is 0.79. Answer is based off of the following calculation: (Time (surgical video) - Time (immersive virtual reality) divided by Time (simulated immersive virtual reality)).

ArmMeasureValue (MEAN)
Immersive Virtual RealityTransfer Effectiveness Ratio (TER)0.79 Ratio Value
Secondary

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.

Time frame: immediately after surgery.

Population: The ToT is calculated as a cumulative ratio. There isn't a spread of data for a single instance of training, however, if we had done more repetitions then we would have incremental values for each. Therefore, the single numerical value of ToT is 0.594 or 59.4%. Answer is based off of the following calculation: (Time (surgical video) - Time (immersive virtual reality) divided by the Time (surgical video)) multiplied by 100%.

ArmMeasureValue (MEAN)
Immersive Virtual RealityTransfer of Training (ToT)59.4 Percentage

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026