Loading clinical trials...
Loading clinical trials...
Self-Guided Immersive Virtual Reality Versus Mannequin-based Simulators to Teach the Ultrasound-Guided Supra-Inguinal Fascia Iliaca Block: A Non-inferiority Randomized Controlled Study
This research project aims to see if using immersive virtual reality (iVR) is as good as using traditional mannequins to teach medical staff how to perform a specific nerve block called an ultrasound-guided supra-inguinal fascia iliaca (SIFI) block. This nerve block is important for managing pain in patients with hip fractures, as it can improve recovery, shorten hospital stays, and reduce healthcare costs. Currently, not enough eligible hip fracture patients receive these beneficial nerve blocks. 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.
This research protocol outlines a single-center, non-inferiority randomized controlled trial (RCT) evaluating immersive virtual reality (iVR) against traditional mannequin-based, high-fidelity simulators (HFS) for training medical personnel in the ultrasound-guided supra-inguinal fascia iliaca (SIFI) block. This study addresses the suboptimal PNB utilization for hip fracture analgesia, despite evidence supporting their benefits, with fewer than 20% of eligible patients in Ontario and at The Ottawa Hospital (TOH) receiving them due to institutional or provider factors. 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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
The Ottawa Hospital
Ottawa, Ontario, Canada
Start Date
June 1, 2025
Primary Completion Date
October 1, 2025
Completion Date
November 1, 2025
Last Updated
June 24, 2025
36
ESTIMATED participants
VR UGRA
OTHER
Mannequin-based simulation
OTHER
Lead Sponsor
The Ottawa Hospital
NCT07442721
NCT07388953
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions