A Multicentre, Randomised Cross-over Equivalence Trial Investigating Knowledge of Anatomy Following Virtual Reality or Standard Teaching in Novice Anaesthetists
Phase: NA
Conditions: Virtual Reality Simulation, Virtual Reality, Education, Medical
Sponsor: Royal National Orthopaedic Hospital NHS Trust

 
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A multicentre, randomised cross-over equivalence trial 
investigating knowledge of anatomy following virtual 
reality or standard teaching in novice anaesthetists 
 
 
 
Short Study Title/Acronym: RA Anatomy – VRvST Study 
 
IRAS ID: 356761 
 
CHIEF INVESTIGATOR: 
 
Dr Boyne Bellew 
Consultant Anaesthetist 
Royal National Orthopaedic Hospital 
Brockley Hill, Stanmore, Middlesex HA7 4LP 
 
Phone:  
Email: boyne.bellew@nhs.net  
 
SPONSOR REPRESENTATIVE: 
 
Miss Emily Stimpson 
Research Management and Governance Lead 
Research & Innovation Centre 
Royal National Orthopaedic Hospital 
Brockley Hill 
Stanmore 
Middlesex 
HA7 4LP 
 
Phone: 020 3947 0272 (Ext: 3041) 
Email: rnoh.rmg@nhs.net  
 
 
 
 
 
 
 
Information in this protocol is confidential and should not be disclosed, other than to those directly involved in the execution or 
the ethical review of the study, without written authorisation from RNOH RIC. 
 
 
 
 

 
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Signature Page  
The undersigned confirm that the following protocol has been agreed and accepted and that the 
Chief Investigator agrees to conduct the study in compliance with the approved protocol and will 
adhere to the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other 
regulatory requirement. 
 
I agree to ensure that the confidential information contained in this document will not be used 
for any other purpose other than the evaluation or conduct of the investigation without the prior 
written consent of the Sponsor. 
 
I also confirm that I will make the findings of the study publicly available through publication or 
other dissemination tools without any unnecessary delay and that an honest accurate and 
transparent account of the study will be given; and that any discrepancies from the study as 
planned in this protocol will be explained. 
 
This protocol has been written in accordance with the Sponsor’s guidance for writing non-CTIMP 
protocols.  
 
 
Chief Investigator (CI) 
 
 
Dr Boyne Bellew 
Consultant Anaesthetist 
Royal National Orthopaedic Hospital 
NHS Trust (RNOH) 
Signature 
Date 
Principal Investigator (PI)  
(if different from CI) 
 
 
N/A 
 
 
N/A  
Signature 
Date 
Sponsor Representative 
 
 
Miss Emily Stimpson 
Research Management and 
Governance Lead 
Royal National Orthopaedic Hospital 
NHS Trust (RNOH) 
Signature 
Date 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of contents 
 
1. 
LIST OF ABBREVIATIONS 
5 
2. 
STUDY PERSONNEL AND FACILITIES 
6 
3. 
STUDY SYNOPSIS 
7 
4. 
INTRODUCTION 
8 
4.1 
BACKGROUND 
8 
4.2 
PRE-CLINICAL DATA/CLINICAL DATA 
8 
4.3 
STUDY RATIONALE AND RISK/BENEFIT ANALYSIS 
9 
4.4 
MANAGEMENT OF POTENTIAL STUDY RISKS 
9 
5. 
STUDY OBJECTIVES 
9 
5.1 
PRIMARY OBJECTIVE 
9 
5.2 
SECONDARY OBJECTIVES 
10 
6. 
STUDY DESIGN 
10 
6.1 
OVERALL DESIGN 
10 
6.2 
TREATMENT AND RATIONALE 
11 
6.3 
SCHEMATIC OF STUDY DESIGN 
11 
7. 
ELIGIBILITY CRITERIA 
12 
7.1 
INCLUSION CRITERIA 
12 
ANAESTHETISTS THAT ARE IN A RECOGNISED ROYAL COLLEGE OF ANAESTHETISTS (RCOA) TRAINING 
PROGRAM IN THE UK, ANAESTHETIC TRAINING GRADES (STAGE 1 – 3). 
12 
7.2 
EXCLUSION CRITERIA 
12 
7.3 
DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS AND STOPPING RULES 
12 
8. 
PARTICIPANT RECRUITMENT PROCESS 
12 
9. 
STUDY PROCEDURES 
13 
9.1 
INFORMED CONSENT 
13 
9.2 
RANDOMISATION PROCEDURE 
14 
9.3 
EMERGENCY UN-BLINDING 
14 
10. 
STUDY ASSESSMENTS 
14 
10.1 SCREENING ASSESSMENTS 
14 
10.2 BASELINE ASSESSMENTS 
14 
10.3 TREATMENT PROCEDURE 
14 
10.4 SUBSEQUENT ASSESSMENTS 
15 
10.5 SUMMARY CHART OF STUDY ASSESSMENTS 
15 
11.1 LABORATORY PROCEDURES 
15 
11.2 RADIOLOGY OR ANY OTHER PROCEDURE(S) 
15 
11.3 DEFINITION OF THE END OF STUDY 
15 
12. 
SAFETY REPORTING 
15 

 
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12.1 DEFINITION 
16 
12.2 RECORDING ADVERSE EVENTS (AES) 
16 
12.3 ASSESSMENT OF SAES 
16 
12.4 EXPECTED AES 
16 
12.5 REPORTING OF SAES TO THE SPONSOR AND THE REC 
17 
12.6 THE TYPE AND DURATION OF FOLLOW UP 
18 
12.9 REPORTING URGENT SAFETY MEASURES 
18 
13. 
DATA MANAGEMENT AND QUALITY ASSURANCE 
18 
13.1 
 CONFIDENTIALITY 
18 
13.2 
 DATA COLLECTION TOOL 
18 
13.3 DATA HANDLING AND ANALYSIS 
19 
13.4 ARCHIVING ARRANGEMENTS 
19 
14. 
STATISTICAL DESIGN 
20 
14.1 SAMPLE SIZE AND RECRUITMENT 
20 
14.2 ENDPOINTS 
20 
14.2.1 
 Primary endpoints 
20 
14.2.2 Secondary endpoints 
20 
10.3 TREATMENT PROCEDURE 
20 
14.3 STATISTICAL ANALYSIS PLAN 
21 
14.3.1 
Primary endpoint analysis 
21 
14.3.2 
Secondary endpoint analysis 
22 
14.4 RANDOMISATION 
22 
14.5 INTERIM ANALYSIS (IF APPLICABLE) 
22 
14.6 OTHER STATISTICAL CONSIDERATIONS 
22 
15. 
COMMITTEES INVOLVED IN THE STUDY 
22 
16. 
MONITORING AND AUDITING 
22 
17. 
DIRECT ACCESS TO SOURCE DATA 
22 
18. 
ETHICS AND REGULATORY REQUIREMENTS 
22 
19. 
FINANCE 
23 
20. 
INSURANCE AND INDEMNITY 
23 
21. 
PUBLICATION POLICY 
23 
22. 
STATEMENT OF COMPLIANCE 
23 
23. 
REFERENCES 
24 
24. 
LIST OF PROTOCOL APPENDICES 
26 
 
 
 
 
 
 
 
 

 
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1. LIST OF ABBREVIATIONS  
 
 
AE 
Adverse Event 
AR 
Adverse Reaction 
APR 
Annual Progress Report 
ASR 
Annual Safety Report 
CAG 
Confidentiality Advisory Group 
CI 
Chief Investigator 
CRF 
Case Report Form 
DMC 
Data Monitoring Committee 
GAfREC 
Governance Arrangements for Research Ethics Committees 
GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practice 
HRA 
Health Research Authority  
ICF 
Informed Consent Form 
ISF 
Investigator Site File 
ISRCTN 
ISRCTN – The UK’s Clinical Study Registry 
NHS R&D 
National Health Service Research & Development   
NIMP 
Non-Investigational Medicinal Product 
PI 
Principal Investigator 
PIS 
Participant Information Sheet 
QA 
Quality Assurance 
QC 
Quality Control 
RCT 
Randomised Control Trial 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SAR 
Serious Adverse Reaction 
SDV 
Source Document Verification 
SmPC 
Summary of Product Characteristics  
SOP 
Standard Operating Procedure  
TMF 
Trial Master File 
TMG 
Trial Management Group 
TSC 
Trial Steering Committee 
VR 
Virtual reality 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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2. STUDY PERSONNEL AND FACILITIES 
 
Chief Investigator (CI): 
Dr Boyne Bellew  
 
(RNOH) 
E-mail:  boyne.bellew@nhs.net  
 
Phone:  020 8909 5560 
 
 
Principal Investigator (PI): Prof. Graeme McLeoad  
 
 
(Tayside) 
E-mail:  g.a.mcleod@dundee.ac.uk 
 
Phone:  01382 3235482 
 
Principal Investigator (PI): Dr Nat Haslam  
 
 
(Sunderland) 
E-mail:  nhaslam@doctors.org.uk  
 
Phone:  01382 3235482 
 
Principal Investigator (PI): Dr Rishie Sinha  
 
 
(Nottingham) 
E-mail:  rishie.sinha@nhs.net 
 
Phone:  01159 249 924 
 
 
Statistician: 
Prof. Graeme McLeoad  
 
 
(Tayside) 
E-mail:  g.a.mcleod@dundee.ac.uk 
 
Phone:  01382 3235482 
 
 
Medical Expert:                      Dr Mel McKendrick 
        E-mail:  Mel@OptomizeLimited.onmicrosoft.com  
        Phone:  0141 337 2636 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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3. STUDY SYNOPSIS 
 
Full study title: 
A multicentre, randomised cross-over equivalence trial investigating knowledge of 
anatomy following virtual reality or standard teaching in novice anaesthetists 
Short study title:  
RA Anatomy – VRvST Study 
Chief Investigator: 
DR Boyne Bellew 
Medical 
condition/disease 
under investigation: 
Sonoanatomy knowledge using Virtual Reality 
Study duration: 
24 months 
Primary Objective: 
Score out of 44 on a validated test of anatomy and sono-anatomy 
Secondary  
Objective:  
Before training 
• 
Handedness (Edinburgh Handedness Inventory)  
• 
Subjective sleepiness (Karolinska scale) 
• 
Motor reaction time (Psychomotor Vigilance test) 
• 
Attention control (Anti-Saccade test) 
• 
Mental rotation (Mental Rotation Task) 
• 
Depression Anxiety, Stress (DASS score) 
• 
Visual Search Task (Divided Attention) 
• 
Knowledge pretraining 
 
After training and testing 
• 
Knowledge after training session 
• 
Acceptability: Client Satisfaction Questionnaire (CSQ-8) 
• 
Usability: CyberSickness in Virtual Reality Questionnaire (CSQ-VR) 
• 
Immersion: Witmer and Singer Presence Questionnaire  
• 
Subjective workload (NASA – TLX scale) 
• 
Cognitive Demand Battery (CBD) 
• 
Resource use: Calculation of cost differences between learning    
            Modalities 
Study population:  
Resident anaesthetists 
Recruitment Target: 
102 
Recruitment Window 
(Months): 
6 – 12 months 
Methodology:  
This is a non-clinical randomised controlled trial of resident anaesthetists 
undergoing training in regional anaesthesia. Residents will be randomised to one 
of two groups for each training session day:  
 
Standard anatomical training (Group A) 
 
Virtual reality based anatomical training. (Group B) 
Then followed by another training day session and participants will enter either 
standard or VR teaching depending on the previous allocation:  
 
Standard anatomical training (Group B) 
 
Virtual reality based anatomical training. (Group A) 
Anatomical knowledge will be tested in both groups using an on-line 
questionnaire developed by the Chief Investigator (CI). 
Eligibility criteria: 
Inclusion criteria: 

 
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1. Anaesthetists that are residents in a recognised Royal College of 
Anaesthetists (RCoA) training program  
2. Anaesthetic training grades (Stage 1 – 3). 
Exclusion criteria: 
1. Visual impairment (this does not include wearing glasses/contact lenses) 
2. History of severe diseases affecting physical motion or balance 
3. History of any drugs that may affect physical motion or balance within 12 
hours of the intervention 
4. Pregnancy 
5. Individuals who had consumed alcohol within 24 h of the intervention. 
6. Resident doctors not in a recognised RCOA training program e.g. Staff 
grade anaesthetists. 
Study treatment: (i.e. study intervention if applicable): 
 
Standard teaching – control  
 
Virtual reality teaching – intervention. 
 
 
 
4. INTRODUCTION 
 
4.1 BACKGROUND 
Regional Anaesthesia competency is difficult to achieve within the Royal College of Anaesthetists’ 
(RCoA’s) 2021 curriculum1. Standard teaching includes lectures, volunteer scanning and needling 
practice on plastic phantoms. Cadaver training is limited and expensive. 
 
Knowledge of anatomy relies on 2D drawings and ultrasound images. There is a need to learn 
3D anatomy, including its variations, that allows interactive learning similar to that found using a 
cadaver, but at a distance and at a cheaper price2. 
 
A potential solution is Virtual Reality - the process of being fully immersed in a computer 
generated environment3. Application of VR to anatomical teaching shows promise to accelerate 
learning but application has been marred by limited, poor quality research4.  A systematic review 
of 15 RCTs and 816 students5 showed an improvement in knowledge using VR (SMD 95%) = 
0.53 (0.09 to 0.97); and high homogeneity (I2= 88%). The review recommended future focus 
on satisfaction, cost-effectiveness, and adverse reactions. On the other hand, nine (five non-
systematic) reviews found a lack of robust evidence4. Although realistic immersive systems show 
face validity, this does not necessarily translate to learning3. Moreover, users may fail to perform 
tasks without guidance, under stress, over the long term and on translation to clinical practice.3 
 
There is a clear need to develop innovative ways to ensure training needs are of a high standard 
and meet the RCOA requirements1. From a scientific perspective, it is also important to investigate 
how individuals learn and retain knowledge, non-technical skills6 and the complex interactions 
between cognition, perception and motor control within the immersive environment7.  
 
4.2 PRE-CLINICAL DATA/CLINICAL DATA 
“Overall, the competence-based education model and immersion VR, which represent 2 major 
advances in our medical education armamentarium, have the potential to improve clinical 

 
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performance and increase patient safety. Anaesthesiologists are well positioned to lead the 
development and adoption of these futuristic educational tools given our risk management 
mindset and technical affinity.”2  
 
“It is clear that we need a combination of a bottom- up drive (from clinicians, educators, 
researchers, developers) complemented by top- down initiatives (organisations, funders, 
journals) that facilitate work across disciplines, institutions, fields, sectors and countries to build 
capacity and change perspectives through the use of immersive technologies.”3 
 
“To clarify to what extent VR, AR, or MR can replace or supplement TAE methods, there is a 
primary need for addressing issues regarding the definition of each technology and determining 
which specific TAE methods are used as comparators.”4 
 
“The finding confirms that VR may act as an efficient way to improve the learners’ level of 
anatomy knowledge. Future research should assess other factors like degree of satisfaction, cost-
effectiveness, and adverse reactions when evaluating the teaching effectiveness of VR in 
anatomy.”5 
 
4.3 STUDY RATIONALE AND RISK/BENEFIT ANALYSIS 
We propose that in order to develop a sound knowledge of anatomy and sono-antomy, virtual 
reality could be used as an aid to understanding and interpreting 2-D sono-antomical structures. 
Trainees will have an enhanced learning experience that reinforces the skills required to perform 
safe regional anaesthesia 
Hypothesis: We hypothesise that knowledge of regional nerve anatomy among novice 
anaesthetists using 3D virtual reality is equivalent to standard teaching. 
 
4.4 MANAGEMENT OF POTENTIAL STUDY RISKS 
One potential major weakness is the risk of trainer bias when delivering training. The knowledge 
test was written by Dr Bellew, and that Dr Bellew and Prof McLeod will be delivering the ‘VR 
training’ and ‘standard training’ arms respectively. The possibility exists for the trainers to bias 
results by providing test-specific training to one arm, but not the other. To mitigate this risk 
training packages with specific anatomical areas taught and check lists will be used by an observer 
to ensure all aspects are taught and/or omitted as per the training package.  
 
Virtual reality is usually regarded as safe to use. There are reports of it causing headache, 
eyestrain, fatigue, blurred vision and dizziness with prolonged use. These symptoms tend to get 
better shortly after participants stop using the virtual reality equipment. We will minimise the risk 
of these symptoms by limiting the use of the virtual reality headset to 2 – 3 x 30-40 minute 
sessions within an eight-hour period. We will be assessing for these side effects using validated 
questionnaires. Also, the VR environment will be projected onto a screen for participants if they 
need to remove the VR equipment. 
 
5. STUDY OBJECTIVES 
 
5.1 PRIMARY OBJECTIVE 
Our primary aim is to study knowledge of anatomy following initial VR teaching compared to 
standard teaching 

 
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Primary end-point: Score out of 44 on a validated test of anatomy and sono-anatomy 
 
5.2 SECONDARY OBJECTIVES 
Secondary objectives and end-points: 
 
Before training 
 
Handedness (Edinburgh Handedness Inventory)  
 
Subjective sleepiness (Karolinska scale) 
 
Motor reaction time (Psychomotor Vigilance test) 
 
Attention control (Anti-Saccade test) 
 
Mental rotation (Mental Rotation Task) 
 
Depression Anxiety, Stress (DASS score) 
 
Visual Search Task (Divided Attention) 
 Knowledge pretraining 
 
After training and testing 
 
Knowledge after each training session 
 
Acceptability: Client Satisfaction Questionnaire (CSQ-8) 
 
Usability: CyberSickness in Virtual Reality Questionnaire (CSQ-VR) 
 
Immersion: Witmer and Singer Presence Questionnaire  
 
Subjective workload (NASA – TLX scale) 
 
Cognitive Demand Battery (CBD) 
 
Resource use: Calculation of cost differences between learning modalities 
 
6. STUDY DESIGN 
 
6.1 OVERALL DESIGN 
This is a multicentre, non-clinical randomised cross-over equivalence controlled trial of resident 
anaesthetists undergoing simulation training in regional anaesthesia. Residents will be 
randomised to one of two groups for the first training session day:  
• 
Standard anatomical training (Group A) 
• 
Virtual reality based anatomical training. (Group B) 
 
AND participants will then undergo a second training session day 2 – 4 weeks later and will be 
allocated to a group not previously allocated 
• 
Standard anatomical training (Group B) 
• 
Virtual reality based anatomical training. (Group A) 
 
Experimental design and methods  
(Workpackage (WP); Milestone (M); Deliverables (D)) 
 
WP 1 Baseline measurements 
M 1.1 Confirmation of capacity and capability (C&C) at each site 
M 1.2 Inclusion criteria: anaesthetists (non-pregnant) from London, Nottingham, Tayside, 
Sunderland. 

 
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M 1.3 Measure online participant characteristics and psychometric measures (secondary 
outcomes as above) using web based Inquisit Lab 5 platform (Millisecond Software, Seattle). 
 
D1 Report results. 
 
WP 2 Training and testing 
M 2.1 Randomisation Participants will be randomised to one of two groups 
 Standard training  
 VR based training  
 
M 2.2 Psychometric testing (pre training secondary end points as above) 
 
M 2.3 VR familiarisation 
VR training will be preceded by VR familiarisation. Participants will wear Meta Quest 3 VR glasses 
and 
learn 
upper 
and 
lower 
limb 
anatomy 
using 
the 
3D 
Organon 
package 
https://www.3dorganon.com/ that also incorporates sono-anatomy related to regional 
anaesthesia 
 
M 2.4 Training will be structured, last 30 – 40 min and follow the principles of deliberate 
practice. Training will consist of 1:1 trainer: trainee interaction with feedback either after the VR 
session or during the standard training session.  
Training will cover upper and lower limb blocks, truncal and abdominal blocks. The standard 
session will consist of a lecture followed by learning on a plastic anatomical model. All training to 
be provided by Dr Bellew and Prof McLeod at all centres 
 
M 2.5 Testing Knowledge will be tested four occasions and pseudoanonymised using a random 
code generator.  
 
Before training  
 
After training 
       
M 2.6 Questionnaire feedback 
 
Post-test secondary endpoints as above 
       
D 2.1 Conference paper  
       
D 2.2 Journal submission 
 
Testing consists of questions involving sono-anatomy video clips of nerve blocks.  The tests will 
be completed on the on-line platform (r)14 with a built in time limit. Answers will be free-text and 
marked by two blinded raters. All participants will be allocated a code so that results could be 
pseudo-anonymised.  
 
6.2 TREATMENT AND RATIONALE 
N/A 
 
6.3 SCHEMATIC OF STUDY DESIGN 

 
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Recruitment 
 
Demographic data  
 
Psychometric testing 
 
Baseline tests 
 
Randomise 
 
Group A – Standard                     Group B – VR  
 
Testing 
 
2 – 4 week interval 
 
Group B - Standard 
 
Group A – VR 
 
Testing 
 
Data analysis 
 
7. ELIGIBILITY CRITERIA 
 
7.1 INCLUSION CRITERIA 
 
Anaesthetists that are in a recognised Royal College of Anaesthetists (RCoA) training 
program in the Uk, Anaesthetic training grades (Stage 1 – 3). 
 
7.2 EXCLUSION CRITERIA 
 
Visual impairment (this does not include wearing glasses/contact lenses)  
 
History of severe diseases affecting physical motion or balance  
 
History of any drugs that may affect physical motion or balance within 12 hours of the 
intervention 
 
Pregnancy  
 
Individuals who had consumed alcohol within 24 h of the intervention. 
 
7.3 DISCONTINUATION/WITHDRAWAL OF PARTICIPANTS AND STOPPING RULES 
Each participant has the right to withdraw at any time. If a participant withdraws, we will continue 
to analyse any data already collected, unless they express a wish for any associated data to be 
destroyed. 
 
8. PARTICIPANT RECRUITMENT PROCESS 
 
Participant recruitment at a site will only commence once the study team has ensured that the 
following approvals/essential documents are in place:  
 

 
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1. Health Research Authority (HRA) approval 
2. Local Site Delegation of Duties and Signature Log is completed (if applicable) 
3. Confirmation of Capacity and Capability. 
 
All sites participating in the study will also be asked to provide a copy of the following:  
1. Signed Organisation Information Document (OID) or model agreement, as agreed 
with the Sponsor 
2. Confirmation of Capacity and Capability 
3. Sponsor greenlight (if applicable).  
 
Potential participants will be those resident doctors enrolled in a RCoA recognised anaesthetic 
training program. Participants will be recruited via advertised email to anaesthetic departments 
in the UK, Heads of Schools of training will also be asked to disseminate emails and via local 
messaging groups within the various Schools of anaesthesia. 
 
9. STUDY PROCEDURES  
 
9.1 INFORMED CONSENT 
Consent to enter the study will be sought from each participant only after a full explanation has 
been given, an information leaflet offered, and time allowed for consideration. Signed participant 
consent will be obtained. The right of the participant to refuse to participate without giving 
reasons must be respected. All participants are free to withdraw at any time. 
 
Informed consent will be obtained by the Chief Investigator (CI), Principal Investigator (PI) 
and/or a nominated deputy as recorded on Sponsor’s Delegation of Responsibilities Log locally.  
 
Consent to enter this study will be obtained after a full account has been provided of its nature, 
purpose, risks, burdens and potential benefits, and the participant has had the opportunity to 
deliberate. The participant will be allowed to specify the time they wish to spend deliberating, 
usually up to 24 hours.  
 
Periods shorter than 24 hours will be permitted if the participant feels that further deliberation 
will not lead to a change in their decision, and provided the person seeking consent is satisfied 
that the participant has fully retained, understood and deliberated on the information given.  
 
Likewise, periods longer than 24 hours will be permitted should the participant request this. The 
Investigator or designee will explain that the participants are under no obligation to enter the 
study and that they can withdraw at any time during the study, without having to give a reason. 
 
A copy of the signed Informed Consent Form (ICF), along with a copy of the most recent approved 
Participant Information Sheet (PIS) will be given to the study participant. The original signed 
consent form will be retained at the study site and filed in the Site Investigator File (ISF) / Trial 
Master File (TMF).  
 
If new safety information results in significant changes to the risk–benefit assessment, the 
consent form and Participant Information Sheet will be reviewed and updated if necessary. All 
subjects, including those already enrolled, will be informed of the new information, given a copy 

 
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of the revised consent form and PIS and asked to re-consent if they choose to continue in the 
study. 
 
9.2 RANDOMISATION PROCEDURE 
A computer-generated program for random numbers will be used for simple randomization of 
participants https://www.randomizer.org/   
 
This is a non-clinical randomised controlled trial of resident anaesthetists undergoing simulation 
training in regional anaesthesia. Residents will be randomised to one of two groups for each 
training session day:  
 
Standard anatomical training (Group A) 
 
Virtual reality based anatomical training. (Group B) 
AND followed 2 – 4 weeks later 
 
Standard anatomical training (Group B) 
 
Virtual reality based anatomical training. (Group A). 
 
9.3 EMERGENCY UN-BLINDING 
N/A 
 
10. 
STUDY ASSESSMENTS 
 
10.1 SCREENING ASSESSMENTS 
Baseline demographic data: Age, Sex, Handedness, Training level, Peripheral nerve block 
experience. 
 
10.2 BASELINE ASSESSMENTS 
Before training 
 
Handedness (Edinburgh Handedness Inventory)  
 
Subjective sleepiness (Karolinska scale) 
 
Motor reaction time (Psychomotor Vigilance test) 
 
Attention control (Anti-Saccade test) 
 
Mental rotation (Mental Rotation Task) 
 
Depression Anxiety, Stress (DASS score) 
 
Visual Search Task (Divided Attention) 
 Knowledge pretraining 
 
10.3 TREATMENT PROCEDURE 
After training and testing 
 
Knowledge after each training session 
 
Acceptability: Client Satisfaction Questionnaire (CSQ-8) 
 
Usability: CyberSickness in Virtual Reality Questionnaire (CSQ-VR) 
 
Immersion: Witmer and Singer Presence Questionnaire  
 
Subjective workload (NASA – TLX scale) 
 
Cognitive Demand Battery (CBD) 
 
Resource use: Calculation of cost differences between learning modalities. 
 

 
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10.4 SUBSEQUENT ASSESSMENTS 
N/A 
 
10.5 SUMMARY CHART OF STUDY ASSESSMENTS 
Study schedule of events: 
 
 
11. 
Methods 
11.1 LABORATORY PROCEDURES 
N/A 
 
11.2 RADIOLOGY OR ANY OTHER PROCEDURE(S)  
N/A 
 
Techniques and Interventions 
Virtual Reality - the process of being fully immersed in a computer-generated environment 
teaching anatomy. 
 
 
Tools 
Virtual reality anatomy software: 
https://www.3dorganon.com/ 
 
Virtual reality headset: Metquest 3S: Meta Quest 3S: New mixed reality headset – Shop now | 
Meta Store 
 
11.3 DEFINITION OF THE END OF STUDY 
The end of the study is the final outcome measure assessments taken from the final study 
participant. 
12. 
SAFETY REPORTING 
 
 
Recruitment 
Pre-baseline 
Baseline 
2 - 4 weeks 
Consent 
x 
 
 
 
Psychometrics on-line 
 
x 
 
 
Training 
 
 
x 
X 
Testing 
 
x 
x 
X 
Post test questionnaires 
 
 
x 
X 

 
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12.1 DEFINITION 
Adverse Event (AE) — any untoward medical occurrence in a patient or clinical study subject 
who is administered a treatment and which does not necessarily have a causal relationship with 
this treatment (i.e. any unfavourable or unintended change in the structure (signs), function 
(symptoms), or chemistry (lab data) in a subject to whom a treatment/study procedure has been 
administered, including occurrences unrelated to that product/procedure/device). 
Serious Adverse Event (SAE) – is defined as an untoward occurrence that: 
 Results in death; or  
 Is life-threatening (places the subject, in the view of the Investigator, at immediate 
risk of death) 
 Requires hospitalization or prolongation of existing hospitalization (hospitalisation is 
defined as an inpatient admission, regardless of length of stay; even if it is a 
precautionary measure for observation; including hospitalisation for an elective 
procedure, for a pre-existing condition) 
 Results in persistent or significant disability or incapacity (substantial disruption of 
one’s ability to conduct normal life functions) 
 Consists of a congenital anomaly or birth defect (in offspring of subjects or their 
parents taking the study drug regardless of time of diagnosis) 
 Is otherwise considered medically significant by the investigator. 
 
Important medical events that may not be immediately life-threatening or result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of the 
outcomes listed in the definition of serious will also be considered serious. 
 
12.2 RECORDING ADVERSE EVENTS (AES) 
 
All Adverse Events (AEs) will be recorded in the hospital notes and Case Report Form (CRF). If 
the Investigator suspects that the disease has progressed faster due to the administration of the 
study treatment/procedure, then he/she will report this as an unexpected adverse event to the 
Sponsor and the REC as detailed in Section 12.6.  
 
12.3 ASSESSMENT OF SAES 
Classification and causality of Adverse Events (AEs) will be conducted by local PIs and reviewed 
by the CI. The CI cannot downgrade the site PI’s classification and if there is disagreement which 
cannot be resolved during formal discussion then the assessment of the site PI will be accepted. 
The CI, can however, upgrade the seriousness of an event without consultation with the site PI. 
 
12.4 EXPECTED AES  
We do not anticipant specific adverse events relating to this non-clinical study of training in 
anatomical knowledge. 

 
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12.5 REPORTING OF SAES TO THE SPONSOR AND THE REC 
The CI is responsible for reporting SAEs to the RIC immediately and/or within 24 hours of 
becoming aware of the event in accordance with the process outlined below.   
 
An SAE occurring to a research participant will be reported to the Research Ethics 
Committee (REC) that gave a favorable opinion of the study, the study Sponsor (RNOH 
RIC) and the local R&D Office where in the opinion of the CI/PI the event was:   
 
 
‘Related’: that is, it resulted from administration of any of the research procedures; 
and  
 
‘Unexpected’: that is, the type of event is not listed in the protocol as an expected 
occurrence.  
 
Reports of related and unexpected SAEs will be submitted to the REC within 15 days of the 
CI/PI becoming aware of the event; using the SAE reporting form for non-CTIMPs published 
on the HRA website and entitled non-CTIMP safety report to REC. The form should be 
completed in typescript and signed by the Chief Investigator (CI) prior to submission to the 
REC.  
 
Reports of SAEs in double-blind studies should be un-blinded. 
 
All SAEs that are to be reported to the REC should also be forwarded to the RIC in parallel 
and must be recorded, signed and dated by the Investigator at site. The RIC accepts study 
specific or HRA SAE Forms.  
 
Information can be submitted to the RIC in electronic format: 
 
E-mail: rnoh.rmg@nhs.net  
 
Following submission by the CI, the coordinator of the main REC will acknowledge receipt of 
safety reports within 30 days. It is the responsibility of the CI and his/her research team to send 
a copy of the SAE notification and acknowledgement receipt to the RIC.    
 
The research team also has the responsibility to report SAEs occurring in a certain period (28 
days) after a patient completes the study. Any SAEs reported to the Investigators during this 
phase must be documented in the patient’s medical notes and submitted via an SAE reporting 
form. 
 
Principal Investigators (PI) at all sites will report all SAEs to the Chief Investigator (CI) who will 
review and forward such reports within 24 hours to the study Sponsor. 
 

 
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12.6 THE TYPE AND DURATION OF FOLLOW UP 
In this non-clinical study we do not anticipant adverse events arising from study procedures. In 
the event of an unanticipated adverse event each participant will be followed-up on a one-to-one 
basis by the local PI and/or CI until the event is resolved, in order to ensure safety.  
 
12.9 REPORTING URGENT SAFETY MEASURES 
The Sponsor and/or the Investigator may take appropriate urgent safety measures in order to 
protect the subjects of a clinical study against any immediate hazard to their health or safety. If 
safety measures are taken, REC approval is not required before the measure is taken.  
The Investigator will immediately and in any event no later than 3 days from the date the 
measures are taken, give written notice to the REC and the study Sponsor of the measures taken 
and the circumstances giving rise to those measures. 
In order to prevent any delays in the reporting timelines the Sponsor has delegated this 
responsibility to the CI/PI. Therefore, the CI/PI must report any urgent safety measures to the 
REC directly, and in parallel to the Sponsor. The REC coordinator will acknowledge receipt of 
urgent safety measures via email.  
13. 
DATA MANAGEMENT AND QUALITY ASSURANCE 
13.1 CONFIDENTIALITY  
All data will be handled in accordance with the Data Protection Act (2018), General Data 
Protection Regulation (GDPR) (2018), NHS Caldecott Principles, The UK Policy Framework for 
Health and Social Care Research, and the condition of the REC approval. 
 
The Case Report Forms (CRFs) will not bear the subject’s name or other personal identifiable 
data. The subject’s study Identification Number (ID), will be used for identification. 
 
No data will be shared with any external organisation without appropriate consent and data 
sharing agreement in place, as applicable. 
 
13.2 DATA COLLECTION TOOL  
Case Report Forms (CRF) will be designed by the CI and the final version will be reviewed and 
discussed with the study Sponsor. All data will be entered legibly in black ink with a ball-point 
pen.  If the Investigator makes an error, it will be crossed through with a single line in such a 
way to ensure that the original entry can still be read. The correct entry will then be clearly 
inserted. The amendment will be initialled and dated by the person making the correction 
immediately. Overwriting or use of correction fluid will not be permitted. 
 

 
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It is the Investigator’s responsibility to ensure the accuracy of all data entered and recorded in 
the CRFs. The Delegation of Responsibilities Log will identify all study personnel responsible for 
data collection, entry, handling and managing the database. 
 
There is no requirement for access to medical records. All study data will be entered directly onto 
CRFs either directly by the participant or by the study investigator. 
 
The following standard tools will be executed directly into the CRF: 
 
 
Edinburgh Handedness Inventory 
 
Karolinska scale 
 
Depression Anxiety, Stress score  
 
Client Satisfaction Questionnaire (CSQ-8) 
 
CyberSickness in Virtual Reality Questionnaire (CSQ-VR) 
 
NASA – Task Load Index scale 
 
Witmer and Singer Presence Questionnaire. 
 
The following tools are conducted on an online platform (a unique study identifier will be used if 
required) and their results inputted into the CRF: 
 
 
Psychomotor Vigilance test score 
 
Anti-Saccade test 
 
Mental Rotation Task 
 
Visual Search Task using Divided Attention 
 
Cognitive Demand Battery (CBD)  
 
Anatomical knowledge test score. 
 
13.3 DATA HANDLING AND ANALYSIS 
We will use RStudio to analyse data with appropriate packages.  
Examples include: Library (here, janitor, tidyverse, psych, dplyr, Hmisc, finalfit, ltm, lme4).  
Data will be stored on a University of Dundee managed laptop and OneDrive UoD database. 
Professor McLeod will be responsible for data analysis and storage. He will provide a report using 
Quatro. 
 
13.4 ARCHIVING ARRANGEMENTS 
The study documents (including the Trial Master File (TMF), Case Report Forms (CRFs), Informed 
Consent Forms (ICFs) along with the study database) will be kept for a minimum of five years. 
They will be stored in locked offices within the Royal National Orthopaedic Hospital NHS Trust 
(RNOH). The CI is responsible for the secure archiving of study documents. The study database 
will also be kept electronically on the RNOH computer network, for a minimum of five years.  
 
The study documentation will be prepared for archiving by the CI/PI or research team in line with 
the RIC Archiving SOP.  

 
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Site PI’s will be responsible for archiving all essential study documents for the study, in 
accordance with local R&D SOPs. 
 
14. 
STATISTICAL DESIGN 
14.1 SAMPLE SIZE AND RECRUITMENT 
The study will be a cross-over equivalence study with 2 to 4 week washout period. We will use 
q-q plots to visualise the distribution of the data. If not, data will be transformed (i.e. log 
converted). 
The primary outcome will be the Anatomical Knowledge score out of 44. Using PASS v24.0.2 
(NCSS, Utah,) a two-sample, one-sided t-test for equivalence assuming equal variance, SD = 12, 
Power = 0.90, alpha = 0.05, difference between means = 6 and equivalence limits ± 6 points 
requires 102 participants. Therefore, we will aim to recruit 120 participants and allow for 
withdrawal of up to 15% of participants. 
This will require recruitment of up to 30 participants per centre and require 2 visits to each centre. 
We anticipate this will take 6-12 months. 
 
14.2 ENDPOINTS 
14.2.1 Primary endpoints 
Answers to individual questions I the Anatomical Knowledge test are pass/fail, giving a total range 
of possible scores between 0 and 44 for the assessment. Data will be analysed using a two-
sample, one-sided t-test for equivalence and expressed as mean and differences with 90% 
confidence intervals. 
 
14.2.2 Secondary endpoints 
 
Handedness (Edinburgh Handedness Inventory) expressed as % of left or right 
handedeness 
 
Subjective sleepiness (Karolinska scale). Eight point scale from extremely alert to 
extremely sleepy 
 
Motor reaction time (Psychomotor Vigilance test) – measures response time  in 
milliseconds6 
 
Attention control (Anti-Saccade test) – a test of inhibitory control by tracking eye 
movements away from or towards targets in milliseconds)7 
 
Mental rotation (Mental Rotation Task) – Correct proportion of responses and time taken 
in milliseconds8 
 
Depression Anxiety, Stress (DASS score) 
 
Visual Search Task (Divided Attention) - Correct proportion of responses and time taken 
in milliseconds9 
 
10.3 TREATMENT PROCEDURE 

 
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After training and testing 
 
Acceptability: Client Satisfaction Questionnaire (CSQ-8) – Eight questions assessed using 
4-point categorical scale from poor to excellent10 
 
Usability: CyberSickness in Virtual Reality Questionnaire (CSQ-VR)11 
 
Immersion: Witmer and Singer Presence Questionnaire12  
 
Subjective workload (NASA – TLX scale) – Six items judged on 21-point scale13 
 
Cognitive Demand Battery (CBD) – Target difference and duration in milliseconds14 
 
Resource use: Calculation of cost differences between learning modalities 
 
14.3 STATISTICAL ANALYSIS PLAN 
 
Recruitment 
 
Demographic data  
 
Psychometric testing 
 
Baseline tests 
 
Randomise 
 
Group A – Standard                     Group B – VR  
 
Testing 
 
2 – 4 week interval 
 
Group B - Standard 
 
Group A – VR 
 
Testing 
 
Data analysis 
 
14.3.1 Primary endpoint analysis 
Answers will be pass/fail, giving a range of scores between 0 and 44 for the knowledge test. Data 
will be analysed using a two-sample, one-sided t-test for equivalence and expressed as mean 
and differences with 90% confidence intervals. The primary outcome will be the score out of 44. 
Using PASS v24.0.2 (NCSS, Utah,) a two-sample, one-sided t-test for equivalence assuming equal 
variance, SD = 12, Power = 0.90, alpha = 0.05, difference between means = 6 and equivalence 
limits ± 6 points requires 102 participants. Therefore, we will aim to recruit 120 participants and 
allow for withdrawal of up to 15% of participants. 
This will require recruitment of up to 30 participants per centre and require 8 visits to each centre. 
We anticipate this will take 4 months. 
 

 
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14.3.2 Secondary endpoint analysis 
Secondary analyses will be performed based on the type of data and their distribution. 
Comparison of groups will use parametric or non parametric tests as appropriate. 
 
14.4 RANDOMISATION 
Randomised cross over design for equivalence. 
 
14.5 INTERIM ANALYSIS (IF APPLICABLE) 
Not applicable 
 
14.6 OTHER STATISTICAL CONSIDERATIONS 
Not applicable 
 
15. 
COMMITTEES INVOLVED IN THE STUDY 
1. Trial Management Group (TMG) – This will consist of the study investigators and be chaired 
by the Chief Investigator (CI). The role of the group is to monitor all aspects of the conduct and 
progress of the trial, ensure that the protocol is adhered to and take appropriate action to 
safeguard participants and the quality of the trial itself. It will meet (using online platform) at 
least once per month during the study but it is anticipated that the TMG will conduct ad hoc 
meetings and correspondence via email on a more regular basis to ensure study proceeds on 
time.  
16. 
MONITORING AND AUDITING 
The requirement for study monitoring or audit will be based on the internal RNOH RIC risk 
assessment procedure and applicable Standard Operating Procedures (SOPs). It is the 
responsibility of the RIC to determine the monitoring risk assessment and explain the rationale 
to the study research team. 
 
Study monitoring and/or audit will be discussed with the CI before arrangements are made to 
conduct the visit.  
17. 
DIRECT ACCESS TO SOURCE DATA 
The Investigator(s)/institution(s) will permit study-related monitoring, audits, REC review, and 
regulatory inspection(s), providing direct access to source data/documents. Study participants 
are informed of this during the informed consent discussion.  
18. 
ETHICS AND REGULATORY REQUIREMENTS 

 
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The Sponsor will ensure that the study protocol, Participant Information Sheet (PIS), Informed 
Consent Form (ICF) are submitted supporting documents have been approved by the Health 
Research Authority (HRA) which includes Research Ethics Committee (REC) approval if applicable, 
prior to any participant recruitment taking place. The protocol and all agreed substantial protocol 
amendments, will be documented and submitted for HRA approval prior to implementation. 
 
Before site(s) can enrol participants into the study confirmation of capacity and capability must 
be issued by the institution hosting the trial (unless HRA specifically has confirmed in the HRA 
approval letter that this is not required). It is the responsibility of the PI at each site to ensure 
that all subsequent amendments gain the necessary approvals by the participating site. This does 
not affect the individual clinician’s responsibility to take immediate action if thought necessary to 
protect the health and interest of individual participants. 
 
Within 90 days after the end of the study, the CI will ensure that the REC is notified that the 
study has finished. If the study is terminated prematurely, those reports will be made within 15 
days after the end of the study. 
 
The CI will supply a final summary report of the clinical study to the REC and the Sponsor in 
parallel within one year after the end of the study. 
19. 
FINANCE 
This study is funded by the National Institute of Academic Anaesthesia and Regional Anaesthesia 
UK Society grant. 
20. 
INSURANCE AND INDEMNITY 
NHS bodies are liable for clinical negligence and other negligent harm to individuals covered by 
their duty of care. NHS Institutions employing researchers are liable for negligent harm caused 
by the design of studies they initiate.  
21. 
PUBLICATION POLICY 
Data ownership rights will lie with the institution sponsoring the study. 
 
 
22. 
STATEMENT OF COMPLIANCE 
The trial will be conducted in compliance with the protocol, Sponsor’s Standard Operating 
Procedures (SOPs), GCP and the applicable regulatory requirement(s). 
 
The study conduct shall comply with all relevant laws of the  UK country in which the study site 
is located including but not limited to, the Human Rights Act 1998, the Data Protection Act 2018, 

 
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and with all relevant guidance relating to medicines and clinical studies from time to time in force 
including, but not limited to, the ICH GCP, the World Medical Association Declaration of Helsinki 
entitled 'Ethical Principles for Medical Research Involving Human Subjects' (2008 Version), the 
UK Policy Framework for Health and Social Care Research.    
 
This study will be conducted in compliance with the protocol approved by HRA and according to 
RGF standards. No deviation from the protocol will be implemented without the prior review and 
approval of the Sponsor and HRA, except where it may be necessary to eliminate an immediate 
hazard to a research subject. In such case, the deviation will be reported to the Sponsor and the 
REC as soon as possible. 
 
23. 
REFERENCES 
1. 
Anaesthetists RCoA. Curriculum Learning Syllabus   
2. 
Orser BA, Spadafora SM. Competence-Based Training and Immersion Virtual Reality: 
Paradigm-Shifting Advances in Medical Education. Anesth Analg 2022; 135: 220-2. 
3. 
Mathew RK, Immersive Healthcare C, Mushtaq F. Three principles for the progress of 
immersive technologies in healthcare training and education. BMJ Simul Technol Enhanc 
Learn 2021; 7: 459-60. 
4. 
Chytas D, Piagkou M, Demesticha T, Tsakotos G, Natsis K. Are extended reality 
technologies (ERTs) more effective than traditional anatomy education methods? Surg 
Radiol Anat 2022; 44: 1215-8. 
5. 
Zhao J, Xu X, Jiang H, Ding Y. The effectiveness of virtual reality-based technology on 
anatomy teaching: a meta-analysis of randomized controlled studies. BMC Med Educ 
2020; 20: 127. 
6. 
Thomann, J.; R. Baumann, C.R.; Landolt, H.-P.; & Werth, E (2014). Psychomotor 
Vigilance Task Demonstrates Impaired Vigilance in Disorders with Excessive Daytime 
Sleepiness. Journal of Clinical Sleep Medicine, Vol. 10, 1019-1024. 
7. 
Sereno, A.B. & Holzman, P.S. (1995). Antisaccades and Smooth Pursuit Eye Movements 
in Schizophrenia. BIOL PSYCHIATRY, 37, 394-401. 
8. 
Shepard, S., & Metzler, D. (January 01, 1988). Mental rotation: effects of dimensionality 
of objects and type of task. Journal of Experimental Psychology. Human Perception and 
Performance, 14, 1, 3-11. 
9. 
Motter,B.C., & Simoni, D.A. (2008). Changes in the functional visual field during search 
with and without eye movements. Vision Research 48 (2008) 2382–2393. 
10. 
Attkisson, C. C., & Zwick, R. (1982). Client Satisfaction Questionnaire-8 (CSQ-8) 
[Database record]. PsycTESTS. https://doi.org/10.1037/t50119-000 
11. 
Kourtesis, P.; Linnell, J.; Amir, R.; Argelaguet, F.; MacPherson, S.E. Cybersickness in 
Virtual Reality Questionnaire (CSQ-VR): A Validation and Comparison against SSQ and 
VRSQ. Virtual Worlds 2023, 2, 16–35. 
12. 
Witmer, B. G., & Singer, M. J. (1998). Measuring presence in virtual environments: A 
presence questionnaire. Presence: Teleoperators and Virtual Environments, 7(3), 225–
240.   

 
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13. 
Hart, S. G., & Staveland, L. E. (1988). Development of a multi-dimensional workload 
rating scale: Results of empirical and theoretical research. In P. A. Hancock & N. 
Meshkati (Eds.), Human mental workload, 139-183. Amsterdam, The Netherlands: 
Elsevier. 
14. 
Kennedy, D. O., Haskell, C. F., Robertson, B., Reay, J., Brewster-Maund, C., 
Luedemann, J., Maggini, S., Ruf, M., Zangara, A., & Scholey, A. B. (2008). Improved 
cognitive performance and mental fatigue following a multi-vitamin and mineral 
supplement with added guaraná ( Paullinia cupana). Appetite, 50(2), 506–513. 
https://doi.org/10.1016/j.appet.2007.10.007 
15. 
Alam F, Matava C. A New Virtual World? The Future of Immersive Environments in 
Anesthesiology. Anesth Analg 2022; 135: 230-8. 
16. 
Chuan A, Bogdanovych A, Moran B, et al. Using Virtual Reality to teach ultrasound-
guided needling skills for regional anaesthesia: A randomised controlled trial. J Clin 
Anesth 2024; 97: 111535. 
17. 
Mustafa A, Seeley J, Munirama S, et al. Investigation into the visual perceptive ability of 
anaesthetists during ultrasound-guided interscalene and femoral blocks conducted on 
soft embalmed cadavers: a randomised single-blind study. Br J Anaesth 2018; 120: 854-
9. 
18. 
McLeod G, McKendrick M, Taylor A, et al. Validity and reliability of metrics for translation 
of regional anaesthesia performance from cadavers to patients. Br J Anaesth 2019; 123: 
368-77. 
19. 
McLeod GA, McKendrick M, Taylor A, et al. An initial evaluation of the effect of a novel 
regional block needle with tip-tracking technology on the novice performance of 
cadaveric ultrasound-guided sciatic nerve block. Anaesthesia 2020; 75: 80-8. 
20. 
McKendrick M, Sadler A, Taylor A, et al. The effect of an ultrasound-activated needle tip 
tracker needle on the performance of sciatic nerve block on a soft embalmed Thiel 
cadaver. Anaesthesia 2021; 76: 209-17. 
21. 
McKendrick M, Yang S, McLeod GA. The use of artificial intelligence and robotics in 
regional anaesthesia. Anaesthesia 2021; 76 Suppl 1: 171-81. 
22. 
McLeod G, McKendrick M, Tafili T, et al. Patterns of Skills Acquisition in Anesthesiologists 
During Simulated Interscalene Block Training on a Soft Embalmed Thiel Cadaver: Cohort 
Study. JMIR Med Educ 2022; 8: e32840. 
23. 
Chuan A, Qian J, Bogdanovych A, Kumar A, McKendrick M, McLeod G. Design and 
validation of a virtual reality trainer for ultrasound-guided regional anaesthesia. 
Anaesthesia 2023; 78: 739-46. 
24. 
McLeod G, Chuan A, McKendrick M. Attaining expertise in regional anaesthesia training 
using a multifactorial approach incorporating deliberate practice. Br J Anaesth 2024; 
133: 494-9. 
25 
McLeod G, Seeley J, Wilson M, et al. Development and validation of metrics for 
assessment of ultrasound-guided fascial block skills(☆). Br J Anaesth 2024. 
26. 
McLeod G, McKendrick M, McKendrick G, Portelli R, James G, Guntur P. Development of 
an augmented reality system for simulated thoracic epidural block training on the soft 
embalmed Thiel cadaver. Br J Anaesth 2024; 132: 455-6. 
27. 
Huebner A, Lucht M. Generalizability Theory in R. Practical Assessment, Research & 
Evaluation 2019; 24. 

 
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28. 
Ferry J, Lewis O, Lloyd J, et al. Research priorities in regional anaesthesia: an 
international Delphi study. Br J Anaesth 2024; 132: 1041-8. 
 
24. 
LIST OF PROTOCOL APPENDICES 
Appendix 1 Study Assessments  
 
Handedness (Edinburgh Handedness Inventory)  
 
 
 
 

 
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Subjective sleepiness (Karolinska scale) 
 
 
 
 
 
 
 
 
 

 
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Motor reaction time (Psychomotor Vigilance test) 
Psychomotor Vigilance Test - Millisecond 
Attention control (Anti-Saccade test) 
AntiSaccade Task - Millisecond 
Mental rotation (Mental Rotation Task) 
Mental Rotation - Millisecond 
Depression Anxiety, Stress (DASS score) 
Depression Anxiety and Stress Scale (DASS) - Millisecond 
Visual Search Task (Divided Attention) 
Visual Search Task - Millisecond 
Knowledge pre-training 
https://www.classmarker.com/online-test/start/?quiz=qkv65b26f703fd6d (Sample question) 
Acceptability: Client Satisfaction Questionnaire (CSQ-8) 
CSQ Versions – CSQScales 
Usability: CyberSickness in Virtual Reality Questionnaire (CSQ-VR) 
OSF | CSQ-VR_CybersicknessVRQuestionnaire111 (1).pdf 
Immersion: Witmer and Singer Presence Questionnaire  
PRESENCE QUESTIONNAIRE (wordpress.com) 
Subjective workload (NASA – TLX scale) 
NASA Task Load Index (NASATLX) - Millisecond  
Cognitive Demand Battery (CBD) 
Cognitive Demand Battery (CDB) - Millisecond 
  
Inquisit software 
Millisecond 
 
Sample regional anaesthesia workshop videos 
Erector Spinae Plane Block - YouTube 
 
 

Appendix 1 
Summary chart of study Assessments (Template) 
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Please see Section 10.3 of the study protocol.
 
 
 
 
 
 
 
 

Appendix 2 
Summary of Amendment History (Template) 
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List details of all protocol amendments here whenever a new version of the protocol is produced. 
All study amendments must be submitted to the Sponsor for approval prior to submission to the REC/HRA. 
 
 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made