Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001144808
Ethics application status
Approved
Date submitted
15/07/2021
Date registered
25/08/2021
Date last updated
23/02/2024
Date data sharing statement initially provided
25/08/2021
Date results provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Using virtual reality to teach real-time ultrasound-guided needling skills: A randomised controlled trial
Scientific title
The effectiveness of virtual reality (VR) training against standard (face-to-face, didactic) training of ultrasound-guided nerve blocks for medical students.
Secondary ID [1] 304768 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical Simulation 322822 0
Medical Education 322823 0
Condition category
Condition code
Anaesthesiology 320413 320413 0 0
Anaesthetics
Public Health 320676 320676 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective, double-blinded, randomised controlled trial, single-site study comparing the effectiveness of VR training against standard training (a face-to-face, didactic training). Participants will be medical students with no experience in ultrasound-guided procedures or regional anaesthesia. Demographic data such as age, gender, years of video game use and mental health using the Depression Anxiety Stress Scale-21 will be collected.

All participants will be asked to view a 10-minute online video before the training day, with a link provided 1 month in advance, which explains the basic ultrasound physics, transducer movements and needle guidance. 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.

The practical component of the trial will be held over two consecutive days in May 2023, at the Thomas Moore simulation centre, Liverpool Hospital. All participants will be shown the video again, and their baseline needling skill will be tested. Participants will attempt an ultrasound-guided needle procedure, placing 1ml of saline above and below the target tendon structure on pork meat embedded with bovine tendon, within 600 seconds. Two assessors will independently score the performance of each participant using a global rating scale for Ultrasound Guided Regional Anaesthesia (UGRA) and composite error score checklist. Assessors are expert regional anaesthesia consultants. Participants will be asked to complete the National Aeronautics and Space Administration (NASA) task load index questionnaire (NASA-TLX), which scores mental and physical demand, effort and frustration level immediately after completion of the task.

Participants will then be randomised into VR group (intervention) and standard teaching group (control). Our research group has created a bespoke VR software and holds intellectual property. There was no commercial funding or commercial conflicts of interest with the use of the VR training software. VR participants will experience 2x 30-minute sessions of VR training using the virtual reality trainer, with a 10-minute rest between sessions. Virtual reality software will be on a Lenovo gaming laptop and displayed to the participant via head mounted display with dual hand controllers. Each participant will have their own device. A researcher will be present at all times to assist with the set up and running of the VR software but will not interfere with the training. The control group will have a didactic and practical workshop.

The final test will be conducted immediately after the training sessions on the same day. As the final test, all study participants will then be reassessed using baseline test; ultrasound-guided nerve blocks on the pork model. Two independent assessors will score using the same global rating scale for UGRA and composite error scale checklist. Participants will be asked to complete the NASA-TLX questionnaire again.
Intervention code [1] 321150 0
Treatment: Other
Comparator / control treatment
Standard training group will undergo a didactic workshop taught by an experienced medical doctor. It is designed to mimic a typical workshop found in conferences and departmental registrar teaching sessions. There will be 2x identical 30min sessions, with a 10 min rest period. Each session is composed of 2 stations of 15 min each, one station to teach ultrasound skills using a pork-tendon model to practice skills. A researcher will be present at all times to assist and monitor the running of the session but will not interfere with the training.
Control group
Active

Outcomes
Primary outcome [1] 328258 0
Difference in student performance of ultrasound guided techniques will be determined using the global rating scale (7-item 5-point Likert scale) for UGRA final scores between the virtual reality group and standard group, marked by two independent assessors through an iterative process.

This global rating scale has been used in previous regional anaesthesia studies and are validated with moderate to high inter-observer reliability.
Timepoint [1] 328258 0
Immediately after the final test.
Secondary outcome [1] 398267 0
Difference in composite error scores using a checklist for needling tasks in ultrasound-guided regional anaesthesia between the virtual reality group and standard group, when measured by the same two independent assessors.

This composite error score has been used in previous regional anaesthesia studies and are validated with moderate to high inter-observer reliability.
Timepoint [1] 398267 0
Immediately after the final test.
Secondary outcome [2] 399247 0
Self-assessment of cognitive task load using the NASA-TLX questionnaire within the groups.
Timepoint [2] 399247 0
Immediately after the final test.
Secondary outcome [3] 419771 0
Individualised learning curves generated from data collected automatically by the VR software during VR training
Timepoint [3] 419771 0
immediately after the final test

Eligibility
Key inclusion criteria
Medical students who are novices to ultrasound-guided procedures or regional anaesthesia (no prior exposure to lectures, tutorials, workshops or clinical hands-on experience with ultrasound or nerve blocks).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria apart from prior exposure to ultrasound and/or regional anaesthesia procedures.

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)
Allocation concealed using central randomisation by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation, 1:1 allocation, in blocks of 4, stratified by gender.
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
Participant data will be evaluated descriptively. The continuous primary outcome of global rating scale scores will be analysed with analysis of covariance (ANCOVA) to account for change in baseline scores. Confounding variables (eg. DASS anxiety score, gaming experience) will be assessed via Directed Acyclic Graphs and change in effect with the estimates adjusted accordingly.

Composite error scores are typically non-parametric and will be analysed using the Mann-Whitney U test. Inter-rater agreement between assessor scoring will use 2-way, mixed effect, average measures, absolute agreement, intra-class correlation coefficient (ICC 2A,k) model. NASA-TLX scores will be assessed within-groups paired t-test to determine rate of change after training. The level of virtual reality presence will be descriptively reported from the Witmer and Singer score.

Data analyses will be performed using R version 4.0.1, and RStudio.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/05/2023
Actual
13/05/2023
Date of last participant enrolment
Anticipated
14/05/2023
Actual
14/05/2023
Date of last data collection
Anticipated
14/05/2023
Actual
14/05/2023
Sample size
Target
40
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19969 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 34677 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 309133 0
Charities/Societies/Foundations
Name [1] 309133 0
Australian and New Zealand College of Anaesthetists
Country [1] 309133 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Thomas and Rachel Moore Education Centre,
Liverpool Hospital,
Elizabeth Street,
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 310105 0
None
Name [1] 310105 0
Address [1] 310105 0
Country [1] 310105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308999 0
South Western Sydney HREC
Ethics committee address [1] 308999 0
Ethics committee country [1] 308999 0
Australia
Date submitted for ethics approval [1] 308999 0
Approval date [1] 308999 0
15/07/2021
Ethics approval number [1] 308999 0

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

Contacts
Principal investigator
Name 112606 0
A/Prof Alwin Chuan
Address 112606 0
Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 112606 0
Australia
Phone 112606 0
+61407743668
Fax 112606 0
Email 112606 0
dr.chuan@iinet.net.au
Contact person for public queries
Name 112607 0
Alwin Chuan
Address 112607 0
Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 112607 0
Australia
Phone 112607 0
+61407743668
Fax 112607 0
Email 112607 0
dr.chuan@iinet.net.au
Contact person for scientific queries
Name 112608 0
Alwin Chuan
Address 112608 0
Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 112608 0
Australia
Phone 112608 0
+61407743668
Fax 112608 0
Email 112608 0
dr.chuan@iinet.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12546Ethical approval  dr.chuan@iinet.net.au



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.