Nerve BlockNCT07035015
Self-Guided Immersive Virtual Reality Versus Mannequin-based Simulators to Teach the Ultrasound-Guided Supra-Inguinal Fascia Iliaca Block
A study testing VR UGRA and Mannequin-based simulation in people with Nerve Block and Hip Fracture Surgeries, run by The Ottawa Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nerve Block, Hip Fracture Surgeries
- What is being tested?
- VR UGRA and Mannequin-based simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Staff and trainees from anesthesiology, emergency medicine, and orthopedic surgery. All participants will be locally recruited within The Ottawa Hospital
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Yuqi Gu, MD FRCPC, (613)737-8187, yugu@toh.ca
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Nerve Block, Hip Fracture Surgeries
- Being tested
- VR UGRA, Mannequin-based simulation
- Keywords
- Virtual Reality, Ultrasound-guided Regional Anesthesia, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR UGRAOther
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 simulationOther
The hybrid simulator will consist of a 3G mannequin and a gel-based part-task trainer.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality UGRA | Experimental | 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 Receives: Other: VR UGRA |
| Mannequin simulation | Active comparator | The hybrid simulator will consist of a 3G mannequin and a gel-based part-task trainer. Receives: Other: Mannequin-based simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Guided Regional Anesthesia Global Rating Scale
The primary outcome is the summation of the UGRA Global Rating Scale (GRS), which is a valid assessment tool to score trainees' performance in UGRA. Previous studies have found a strong correlation in the GRS score between simulated and real clinical settings. The minimum score is 9 and maximum score is 35. A high score represents better procedural performance.
Measured: From enrolment until the 1 month retention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jun 2025
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ottawa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqi Gu, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035015
- Sponsor's protocol ID
- 20240340-01H
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07035015
- Acronym / sponsor ID
- 20240340-01H
- Conditions
- Nerve Block, Hip Fracture Surgeries
- Keywords
- Virtual Reality, Ultrasound-guided Regional Anesthesia, Simulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Ottawa HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality UGRA | Experimental | Other: VR UGRAThe 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 | Active comparator | Other: Mannequin-based simulationThe hybrid simulator will consist of a 3G mannequin and a gel-based part-task trainer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Staff and trainees from anesthesiology, emergency medicine, and orthopedic surgery. All participants will be locally recruited within The Ottawa Hospital
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| VR UGRAThe 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 | Other | Virtual reality UGRA |
| Mannequin-based simulationThe hybrid simulator will consist of a 3G mannequin and a gel-based part-task trainer. | Other | Mannequin simulation |
Primary outcome
Ultrasound Guided Regional Anesthesia Global Rating Scale
Time frame: From enrolment until the 1 month retention.
The primary outcome is the summation of the UGRA Global Rating Scale (GRS), which is a valid assessment tool to score trainees' performance in UGRA. Previous studies have found a strong correlation in the GRS score between simulated and real clinical settings. The minimum score is 9 and maximum score is 35. A high score represents better procedural performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR UGRA and Mannequin-based simulation in people with Nerve Block and Hip Fracture Surgeries, run by The Ottawa Hospital 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 0 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqi Gu, MD FRCPC ((613)737-8187, yugu@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Guided Regional Anesthesia Global Rating Scale (time frame: From enrolment until the 1 month retention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2025.