Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000136606
Ethics application status
Approved
Date submitted
3/02/2023
Date registered
9/02/2023
Date last updated
9/02/2023
Date data sharing statement initially provided
9/02/2023
Date results provided
9/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of a new virtual reality software designed for regional anaesthesia by testing performance between novice and experienced participants
Scientific title
Validation of a virtual reality software designed to train ultrasound-guided regional anaesthesia needling skills
Secondary ID [1] 308900 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a substudy of a planned RCT of standard training versus virtual reality training (ACTRN12621001144808). The virtual reality software is the same for both this study and the RCT

Health condition
Health condition(s) or problem(s) studied:
Ultrasound-guided regional anaesthesia needling skills 328895 0
Medical education and training of procedural skills 328894 0
Condition category
Condition code
Public Health 325949 325949 0 0
Health service research
Anaesthesiology 325890 325890 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Virtual reality can be used as form of simulation-based medical training, replicating real-life scenarios in which participants can learn and rehearse new cognitive and motor skills. A new virtual reality software has been designed to teach needling skills relevant for anaesthetists performing ultrasound-guided regional anaesthesia. Prior to wider spread adoption of this training software, construct validation and comparison to existing metrics is warranted.
This is a fully volunteer observational study of adults who consent to participate after full informed consent.

Groups:
1) 15 novices (defined as no prior exposure to ultrasound, ultrasound-guided regional anaesthesia, or training in nerve blocks) will be recruited from attached medical schools and anaesthesia staff at Liverpool Hospital, Sydney
2) 15 experienced (defined as having previously performed >50 ultrasound-guided regional anaesthesia procedures) will be recruited from anaesthesia staff at Liverpool Hospital, Sydney
All participants are de-identified

Procedure:
Both groups will receive a 10min video on ultrasound, ultrasound-guided needling, and basic transducer skills prior to use of virtual reality.
This video is a composite of two publicly available YouTube educational videos from the Departments of Anaesthesia, University of California San Francisco, USA, and Queen Victoria Hospital, East Grinstead, UK

Immediately after viewing the video, each participant will don the VR equipment and within the VR software, each will be asked to scan a region on the virtual patient and identify the nerve target.
4 locations (nerve targets 1 to 4) are selected for participants to attempt a needling task.
Each participant will be asked to perform the needling task on each 4 nerve targets 10x each (for a total of 40 attempts). This virtual needling period will last for a maximum of 60 min, with a rest break of 10min at 30min offered to participants if necessary.
The virtual reality software calculates a performance score for each attempt based on the time taken, number of withdrawals, and angulation of the needle relative to the transducer

Baseline characteristics taken prior to virtual reality exposure
1) Demographics including age, sex, number of years computing gaming, including previous virtual reality gaming
2) Depression, Anxiety and Stress Scale-21 (DASS-21)
3) NASA-Task Load Index score (NASA-TLX)

After training using the new virtual reality software, endpoints collected include:
1) Performance score generated by the software for each attempt
2) NASA-TLX
3) Witmer and Singer Presence Questionnaire
4) Individual learning curves plotted as performance score versus attempt number
Intervention code [1] 325345 0
Treatment: Other
Comparator / control treatment
Needling performance scores and individual learning curves will be compared between novices and experienced participants (comparator) when both groups are using virtual reality
Control group
Active

Outcomes
Primary outcome [1] 333726 0
Virtual reality presence, based on Presence Questionnaire scores between groups and between all participants versus published established scores for high-fidelity virtual reality environments
Timepoint [1] 333726 0
Immediately after completion of virtual reality training (40 attempts)
Primary outcome [2] 333724 0
Performance scores between novices and experienced participants to provide evidence of construct validity. Performance scores are calculated by the virtual reality software based on time taken, number of withdrawals, and angulation of the needle relative to the transducer
Timepoint [2] 333724 0
Immediately after completion of virtual reality training (40 attempts)
Primary outcome [3] 333725 0
Cognitive-motor load, based on NASA-TLX scores between groups and between all participants versus published equivalent medical procedures
Timepoint [3] 333725 0
Immediately after completion of virtual reality training (40 attempts)
Secondary outcome [1] 418075 0
Generation of individualised learning curves, produced by comparing performance scores over each attempt for each participant
Timepoint [1] 418075 0
Immediately after completion of virtual reality training (40 attempts)

Eligibility
Key inclusion criteria
All adult (>18yo) medical students or anaesthesia staff attached to Liverpool Hospital, Sydney
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Novices having prior exposure to lectures, tutorials, workshops or clinical hands-on experience with ultrasound or nerve blocks are excluded

2) Experienced group to have previously performed at least 50 ultrasound-guided regional anaesthesia blocks prior to study

3) Sufficient English proficiency for informed consent, and be able to understand and complete study questionnaires

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be analysed using t-tests, Mann-Whitney U tests, and chi square tests for categorical data
Performance scores between groups will be analysed using repeated measures ANOVA for both all attempts and for nerve targets 1-4
Presence scores between groups will be analysed using t-tests
NASA-TLX scores between groups will be analysed using t-tests
Individualised learning curves will be generated using log-log scatter plots of performance versus attempt number

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2022
Date of last participant enrolment
Anticipated
Actual
30/06/2022
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
30
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23907 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 39392 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 313110 0
Other
Name [1] 313110 0
Australian and New Zealand College of Anaesthetists
Country [1] 313110 0
Australia
Primary sponsor type
Hospital
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] 314811 0
None
Name [1] 314811 0
Address [1] 314811 0
Country [1] 314811 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312359 0
South West Sydney HREC
Ethics committee address [1] 312359 0
Ethics committee country [1] 312359 0
Australia
Date submitted for ethics approval [1] 312359 0
03/03/2022
Approval date [1] 312359 0
09/03/2022
Ethics approval number [1] 312359 0
2021/ETH01113

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

Contacts
Principal investigator
Name 124374 0
A/Prof Alwin Chuan
Address 124374 0
Department of Anaesthesia New Clinical Building Liverpool Hospital Elizabeth St Liverpool NSW 2170
Country 124374 0
Australia
Phone 124374 0
+61 2 87388582
Fax 124374 0
Email 124374 0
[email protected]
Contact person for public queries
Name 124375 0
Alwin Chuan
Address 124375 0
Department of Anaesthesia New Clinical Building Liverpool Hospital Elizabeth St Liverpool NSW 2170
Country 124375 0
Australia
Phone 124375 0
+61 2 87388582
Fax 124375 0
Email 124375 0
[email protected]
Contact person for scientific queries
Name 124376 0
Alwin Chuan
Address 124376 0
Department of Anaesthesia New Clinical Building Liverpool Hospital Elizabeth St Liverpool NSW 2170
Country 124376 0
Australia
Phone 124376 0
+61 2 87388582
Fax 124376 0
Email 124376 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• case-by-case basis at the discretion of Primary Sponsor, for researchers proposing a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified participant data underlying published results (primary and secondary outcomes)

What types of analyses could be done with individual participant data?
• for researchers proposing a methodologically sound and ethics-approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
available from main results publication and for 5 years after

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator via contact email [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo Basic results summary.docx
Plain language summaryNo A total of 21 novice and 15 experienced participan... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIDesign and validation of a virtual reality trainer for ultrasound-guided regional anaesthesia2023https://doi.org/10.1111/anae.16015
N.B. These documents automatically identified may not have been verified by the study sponsor.