Self-Guided Immersive Virtual Reality Versus Mannequin-based Simulators to Teach the Ultrasound-Guided Supra-Inguinal Fascia Iliaca Block
NCT ID: NCT07035015
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2025-06-01
2025-11-30
Brief Summary
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The study will recruit 36 staff and trainees from anesthesiology, emergency medicine, and orthopedic surgery at The Ottawa Hospital. Participants will be randomly assigned to one of two groups. One group will learn the SIFI block using a newly developed iVR simulator that uses real human anatomy and allows for practice of needling and injecting. The other group will use traditional mannequin-based simulators.
All participants will receive educational materials and videos before their training. Their skills will be tested before the training, immediately after, and again one month later using a hybrid simulator (a combination of a mannequin and a soft embalmed human cadaver part). The main thing being measured is their skill level using a standardized scoring system. The study also wants to see if the iVR simulator is well-tolerated by users. The overall goal is to improve care for hip fracture patients through better, more accessible training for medical staff.
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Detailed Description
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The primary scientific objective is to ascertain if the novel iVR UGRA simulator, featuring veridical human anatomy and real-time simulated interaction, is non-inferior to HFS for imparting SIFI block skills. Secondary endpoints include assessing iVR tolerability (cybersickness, cognitive load) and collecting formative data for platform iteration.
The study cohort will be 36 (target N=40) TOH medical staff and trainees (anesthesiology, emergency medicine, orthopedics), excluding those with \>5 SIFI blocks/year or advanced regional anesthesia training. After informed consent and baseline DASS-21 collection, participants undergo stratified randomization (specialty, PGY level) to the VRS or HFS arm.
Both groups receive standardized didactics (SIFI text, videos on ultrasound, needling, sonoanatomy) followed by 60 minutes of self-directed practice with a checklist. The HFS group uses a 3G mannequin and gel part-task trainer. The VRS group uses the VitaSim iVR simulator (designed with cognitive task analysis and functional task alignment), which currently lacks tactile feedback and patient communication modules.
Skill assessment occurs pre-intervention, immediately post-intervention, and at a 1-month retention interval, involving SIFI block performance on a hybrid simulator (mannequin/Thiel cadaveric model). Performances are video-recorded for blinded, independent rating by two calibrated assessors. The primary outcome is the UGRA Global Rating Scale (GRS) score. Secondary outcomes include checklist scores, procedural duration, needle passes, simulated IM injections, practice time, and for the VRS group, scores on presence, cognitive load, and cybersickness questionnaires.
Sample size (12 per discipline) is based on a non-inferiority margin of 7.6 on the GRS (α=0.05, power=0.9). Statistical analyses via SPSS will include descriptive/inferential statistics (Shapiro-Wilk, t-tests/Wilcoxon, ANCOVA for primary outcome controlling for baseline GRS). Inter-rater reliability uses intraclass correlation coefficients (ICC); significance is p \< 0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Virtual reality UGRA
The simulator applied principles of cognitive task analysis, which is a method aimed at describing the knowledge, cognitive process, and goal structures experts rely upon while performing a complex procedure
VR UGRA
The simulator applied principles of cognitive task analysis, which is a method aimed at describing the knowledge, cognitive process, and goal structures experts rely upon while performing a complex procedure
Mannequin simulation
The hybrid simulator will consist of a 3G mannequin and a gel-based part-task trainer.
Mannequin-based simulation
The hybrid simulator will consist of a 3G mannequin and a gel-based part-task trainer.
Interventions
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VR UGRA
The simulator applied principles of cognitive task analysis, which is a method aimed at describing the knowledge, cognitive process, and goal structures experts rely upon while performing a complex procedure
Mannequin-based simulation
The hybrid simulator will consist of a 3G mannequin and a gel-based part-task trainer.
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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The Ottawa Hospital
OTHER
Responsible Party
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Yuqi Gu
Staff Anesthesiologist and Assistant Professor
Locations
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The Ottawa Hospital
Ottawa, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20240340-01H
Identifier Type: -
Identifier Source: org_study_id
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