Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001308684
Ethics application status
Approved
Date submitted
29/10/2023
Date registered
15/12/2023
Date last updated
15/12/2023
Date data sharing statement initially provided
15/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Gamification of a Virtual Reality Trainer used for Regional Anaesthesia on Educational Outcomes of Novice Participants
Scientific title
Effect of Gamification of a Virtual Reality Trainer used for Ultrasound-Guided Regional Anaesthesia on Educational Outcomes for Novice Participants: A Multicentre Randomised Controlled Trial
Secondary ID [1] 310716 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical education and training of procedural skills 331650 0
Ultrasound-guided regional anaesthesia needling skills 331651 0
Condition category
Condition code
Anaesthesiology 328370 328370 0 0
Anaesthetics
Public Health 328371 328371 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Background:
This randomised controlled trial is investigating if a gamified virtual reality (VR) trainer performs superior to the VR trainer without gamification. The VR trainer is being used to train clinicians in needling procedural skills necessary for competency in ultrasound-guided regional anaesthesia (UGRA) techniques. Gamification refers to purposefully designed educational software that is integrated with elements derived from computer game software. Examples of gamification in this context include: leaderboards, stars for achievements, and accumulated points for reaching competency levels.

Participants:
60 Medical students and Clinicians (junior medical doctors – interns, residents, and registrars) in the Departments of Anaesthesia in Liverpool, Campbelltown and Fairfield Hospitals. The participants are all novices (defined as having < 10 attempts at URGA).
All participants are de-identified.

Groups:
Participants will be divided into 2 equal groups (n=30 each) into Gamified VR training (intervention arm) and Original VR training (comparator arm).

Equipment:
The virtual reality training software will be installed on a gaming laptop with a dedicated NVIDIA graphics card capable of rendering high resolution graphics without lag. These specifications will exceed the minimum hardware requirements of the tethered Oculus Rift S or Oculus Quest 2 head mounted display with dual hand controllers, ensuring smooth VR experience for participants (ie. minimums of > 60Hz refresh rates, < 20 millisecond latencies, 1080x1440 resolution, occlusive headset, and > 90 degrees field of view).

Procedure:
1. Baseline demographics: At the point of recruitment, the following demographic data for each participant will be collected: age, gender, years of video game use, including gaming using virtual reality, and site of recruitment (Liverpool/Campbelltown/Fairfield Hospital).
2. Baseline testing of needling skill: Each participant is then placed in an isolated room, free from distractions. In the room will be a pork meat phantom embedded with bovine tendon adjacent to an ultrasound machine, which is used as the standardised model for all in vitro testing. Each participant will be asked to perform an ultrasound-guided needling attempt, steering the needle to the top (12 o’clock) and bottom (6 o’clock) above and below the target tendon structure. Participants are limited to a maximum of 300 seconds to perform this procedure (they may practice this needling attempt 3 times).
3. Virtual reality training: After an initial orientation, each participant will then experience a 30 minute session (Session 1) of training. This will consist of an initial 10 minutes using the VR trainer (either the Gamified VR or Original VR trainer, depending on their group allocation), followed by a 10 minute rest break during which face-to-face feedback will be provided, and then a further 10 minutes of VR training. The VR trainer teaches the needling techniques necessary for UGRA. The participant has unlimited attempts at practice using the software. A member of the teaching faculty (not involved in assessment or data collection during the study) will inspect the participant’s performance using the metrics produced by the VR trainer software and provide targeted feedback. The participant will then undergo a second 30 minute VR session (Session 2), of the same structure to Session 1, to integrate the feedback and practice further. Both sessions and the feedback will occur within a one week period separated by a minimum of 1 day, and organised pragmatically around the participant’s shiftwork and clinical duties.
4. Final testing of needling skill: At the end of the week of Session 1 and 2 training, each participant will be invited back into an isolated room set up as per the baseline testing. They will be asked to repeat the performance of an ultrasound-guided nerve block on the pork with bovine tendon in vitro model. The performance will be video recorded and edited as previously described. A maximum of 300 seconds will be allowed for the entire procedure.

As the sessions are conducted with a researcher present, adherence is not applicable.
Intervention code [1] 327129 0
Treatment: Other
Comparator / control treatment
The Original VR trainer is a computer-generated, artificial environment designed to replace real-world sensory inputs. Participants can interact within this world, using hand controllers to manipulate objects, while user head movements are replicated by shifting fields of view.

The Gamified VR trainer incorporates two main design philosophies on top of the original: conflict/challenge and reward. Examples of conflict include: unlocking levels, so that users must first successfully complete an easier level before they can progress to the next level; or tasks are designed as progressively harder puzzles to solve. Examples of rewards include: prizes awarded for progress; friendly competition between users with a leaderboard of points scored during training; or a task that can only be completed by cooperating between users.
Control group
Active

Outcomes
Primary outcome [1] 336419 0
Needling performance of Gamified VR-trained participants compared to Original VR-trained participants on an in vitro high-fidelity model.
Timepoint [1] 336419 0
Baseline versus final testing (at the end of the week following Session 1 and Session 2 training).
Secondary outcome [1] 428298 0
Needling performance of Gamified VR-trained participants compared to Original VR-trained participants on an in vitro high-fidelity model.
Timepoint [1] 428298 0
Baseline versus final testing (at the end of the week following Session 1 and Session 2 training).
Secondary outcome [2] 428299 0
Comparison of the gradient and variability of the learning curves of Gamified VR- trained versus Original VR-trained participants in from training session 1 versus session 2. This will be assessed as a composite outcome.
Timepoint [2] 428299 0
Session 1 training versus Session 2 training.
Secondary outcome [3] 428306 0
Questionnaire to participants on their subjective assessment of using VR as a training tool, and for distributed learning (ie. Taking the VR equipment and software home to learn UGRA skills outside of the traditional workplace environment). This will be assessed as a composite outcome.
Timepoint [3] 428306 0
At the end of both Session 1 training and Session 2 training.
Secondary outcome [4] 428307 0
Cognitive loading assessed using the NASA-Task Load Index.
Timepoint [4] 428307 0
At the end of both Session 1 training and Session 2 training.

Eligibility
Key inclusion criteria
1) Participants are novices to UGRA, defined as having <10 previous UGRA attempts.
2) Medical students and residents/registrars rotating into their allocated terms in Anaesthesia in Liverpool, Campbelltown, and Fairfield Hospitals. There is no restriction to age or gender.
3) Sufficient English proficiency for informed consent, and be able to understand and complete study questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation using central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised, computer generated, permuted blocks of 4, stratified by video game use.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
1) Baseline characteristics will be analysed using t-tests, Mann-Whitney U tests, and Chi square tests for categorical data.
2) Global rating scale scores between groups will be analysed using analysis of covariance (ANCOVA).
3) Composite error score and NASA-TLX between groups will be analysed using ANCOVA; within groups is using Mann-Whitney or t-test depending on data distribution
4) Learning curve improvements over time will compare the gradients of the curves in VR Session 1 versus VR session 2, using Spearman tests.
5) The Likert scores from the post-training questionnaire will be treated as parametric and analysed using t test between groups.
6) Inter-rater agreement between assessor scoring of both the global rating scale and the composite error scores will use 2-way, mixed effect, average measures, absolute agreement, intra-class correlation coefficient (ICC 2A,k) model.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25785 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 25786 0
Fairfield Hospital - Prairiewood
Recruitment hospital [3] 25787 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 41611 0
2170 - Liverpool
Recruitment postcode(s) [2] 41612 0
2176 - Prairiewood
Recruitment postcode(s) [3] 41613 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 315386 0
Self funded/Unfunded
Name [1] 315386 0
Country [1] 315386 0
Primary sponsor type
Government body
Name
South West Sydney Local Health District
Address
South Western Sydney Local Health District Executive Office Liverpool Hospital Eastern Campus Scrivener Street LIVERPOOL NSW 2170
Country
Australia
Secondary sponsor category [1] 316936 0
None
Name [1] 316936 0
Address [1] 316936 0
Country [1] 316936 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313922 0
South West Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313922 0
Ethics committee country [1] 313922 0
Australia
Date submitted for ethics approval [1] 313922 0
17/08/2023
Approval date [1] 313922 0
20/09/2023
Ethics approval number [1] 313922 0
2023/STE02698

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129802 0
A/Prof Alwin Chuan
Address 129802 0
Department of Anaesthesia New Clinical Building Liverpool Hospital Elizabeth St Liverpool NSW 2170
Country 129802 0
Australia
Phone 129802 0
+61 407 743 668
Fax 129802 0
Email 129802 0
[email protected]
Contact person for public queries
Name 129803 0
Alwin Chuan
Address 129803 0
Department of Anaesthesia New Clinical Building Liverpool Hospital Elizabeth St Liverpool NSW 2170
Country 129803 0
Australia
Phone 129803 0
+61 407 743 668
Fax 129803 0
Email 129803 0
[email protected]
Contact person for scientific queries
Name 129804 0
Alwin Chuan
Address 129804 0
Department of Anaesthesia New Clinical Building Liverpool Hospital Elizabeth St Liverpool NSW 2170
Country 129804 0
Australia
Phone 129804 0
+61 407 743 668
Fax 129804 0
Email 129804 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data underlying published results (primary and secondary outcomes)
When will data be available (start and end dates)?
Available from main results publication and for 7 years after
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor, for researchers proposing a methodologically sound proposal
Available for what types of analyses?
For researchers proposing a methodologically sound and ethics-approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator via contact email [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.