NCT07035015

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 5, 2025

Last Update Submit

June 15, 2025

Conditions

Keywords

Virtual RealityUltrasound-guided Regional AnesthesiaSimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrolment until the 1 month retention.

Study Arms (2)

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

Other: VR UGRA

Mannequin simulation

ACTIVE COMPARATOR

The hybrid simulator will consist of a 3G mannequin and a gel-based part-task trainer.

Other: Mannequin-based simulation

Interventions

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

Virtual reality UGRA

The hybrid simulator will consist of a 3G mannequin and a gel-based part-task trainer.

Mannequin simulation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Staff and trainees from anesthesiology, emergency medicine, and orthopedic surgery. All participants will be locally recruited within The Ottawa Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Central Study Contacts

Yuqi Gu, MD FRCPC

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist and Assistant Professor

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 24, 2025

Study Start

June 1, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations