Evaluating Virtual Reality as an Adjunct in Procedural Preparation for Magnetic Resonance Imaging (MRI)
Phase: NA
Conditions: Virtual Reality, Paediatrics, Radiology
Sponsor: British Columbia Children's Hospital

Project Plan, Version 3.0 
Aug 9th, 2019 
1
Evaluating Virtual Reality as an Adjunct in Procedural 
Preparation for Magnetic Resonance Imaging (MRI) 
 
A Pilot Project to Reduce Costs while Improving Quality, Access, Efficiency 
and Patient Experience in Medical Imaging at BC Children’s Hospital 
 
 
RESEARCH PLAN 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Document History 
  
 
Ver. 
 
Date 
 
Author 
 
Description of Changes / Comments 
 
1.0 
 
Feb 20/19 
 
C.Stunden 
 
1st Draft 
2.0 
Jun 06/19 
C.Stunden - 
Updated methods following Phase 1 
 
 
 
 

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Contents 
1.0 
Project Team ........................................................................................................... 3 
2.0 
Abbreviations ......................................................................................................... 4 
3.0 
Introduction ............................................................................................................. 5 
4.0 
Methods ................................................................................................................... 7 
4.1 
Key Question(s) .............................................................................................................7 
4.2 
Objectives and Hypotheses ..........................................................................................8 
4.3 
Phase 1: Design and Development of the Virtual Reality Experience .....................8 
The Virtual Reality Simulation ....................................................................................................................... 10 
4.4 
Phase 2: Technology Evaluation and Comparative Assessment .......................... 12 
Protocol for Evaluating the Virtual Reality MRI Simulator ......................................................................... 12 
Outcome Measures ......................................................................................................................................... 18 
Usability Testing .............................................................................................................................................. 21 
Analysis and Interpretation ............................................................................................................................ 21 
4.5 
Phase 3: Economic Evaluation and Impact Modelling ............................................ 22 
Stage 1: Cost Analysis.................................................................................................................................... 22 
Stage 2: Outcomes (Effects) Analysis .......................................................................................................... 23 
Stage 3: Multi-Level Cost-Effectiveness Modelling .................................................................................... 23 
5.0 
References ............................................................................................................ 25 
 

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1.0 Project Team 
 
Responsibility 
Title/Name/Organization 
Contact Information 
Project Director 
John Jacob 
Senior Director,  
Strategy and Innovation 
BCCH 
John.Jacob@cw.bc.ca 
Project Manager 
Chelsea Stunden 
Manager, Research & Evaluation 
BCCH 
Chelsea.Stunden@ubc.ca 
Child Life Co-Lead 
Kirsten Stratton 
Child Life Specialist 
BCCH 
Kirsten.Stratton@cw.bc.ca 
Child Life Co-Lead 
Reyna Webb 
Child Life Specialist 
BCCH 
Rwebb4@cw.bc.ca 

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2.0 Abbreviations 
 
3D 
Three-dimensional (environments) 
BCCH  
British Columbia Children’s Hospital  
CLS 
Child Life (Specialists) 
IPD 
Interpupillary Distance 
LoS  
Length of (Hospital) Stay 
MRI 
Magnetic Resonance Imaging 
PDSA 
Plan-Do-Study-Act cycle 
RA  
Research Assistant 
Short-STAI 
Short State-Trait Anxiety Inventory 
TCPS-2 
Tri-Council Policy Statement 
TRL 
Technology Readiness Level 
VR 
Virtual Reality 
 

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3.0 Introduction 
Operational Context 
Over 4500 patients undergo magnetic resonance imaging (MRI) at BC Children’s Hospital 
(BCCH) each year (Table 1). In 2017/18, the waitlist for sedated cases reached a 
significant point where some patients were forecasted to endure a wait of up to two years 
for their scheduled appointment. To address this, the Hospital launched a coordinated 
strategy that included increased operational capacity and funding for clinical and support 
services. Child Life Specialists (CLS), who are specially trained individuals that work with 
patients and families to help prepare patients for the MRI procedure, were amongst these 
resources. CLS are considered a key factor in enabling some patients to undergo imaging 
without the use of sedation, where otherwise it may have been indicated due to pre-
procedural anxiety and high probability of non-compliant behaviors. While the Hospital 
has invested efforts and resources in improving access to CLS, capacity limitations exist, 
and there are socioeconomic costs of only having this support available on-site at BCCH. 
The Project Team intends to develop a standardized preparatory adjunct delivered using 
virtual reality (VR) technology, and explore the effectiveness of this tool. Ultimately, our 
goal is to explore the potential for this adjunct to complement the existing efforts of the 
Medical Imaging Department and Child Life Specialists to improve access, quality, 
efficiency, and patient experience at BCCH. A core component of this project is to also 
assess the economic impacts of this solution.   
Table 1. Magnetic Resonance Imaging statistics from BC Children’s Hospital (BCCH) 
Child Life Department, Fiscal Year 2018/2019.  
 
Q1 
Q2 
Q3 
Q4 
(as of Feb 22, 2019) 
Non-Sedated 
644 
576 
644 
530 
Sedated 
443 
475 
483 
487 
TOTAL 
1,087 
1,051 
1,127 
1,017 
 
Pre-procedural anxiety and non-compliance  
Fifty percent of pediatric patients experience elevated anxiety and distress prior to new 
medical procedures.1 In children, pre-procedural anxiety has been found to be a function 
of numerous factors, including: caregiver anxiety, temperament, age, previous medical 
encounters, a fear of separation from parents, unfamiliar environments, a loss of control, 
as well as coping with unfamiliar routines, instruments, and procedures.1  
The issue of pre-procedural anxiety is critically important because it not only impacts 
patient experience and is associated with psychological and physiological distress, but it 
can affect the efficiency of medical procedures, length of stay in the hospital (LoS), and 
resource utilization – all of which have economics impacts to both families and the health 

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system. During medical imaging procedures specifically, anxiety can cause non-
compliance or unintentional movement which often leads to failure to complete the 
procedure or poor image quality, necessitating multiple attempts or the use of sedation to 
achieve the desired quality of imaging. The impact of sedating a patient has several 
downstream effects, including the increased potential for adverse events, as well as the 
need for specialized clinical staff (i.e. Anesthesiologists, Post-Anesthetic Care Nurses, 
etc.), medications, and lengthier post-procedural monitoring. Studies have also indicated 
an increase in negative post-procedural outcomes when patients are sedated, such as 
increased pain perception, increased pharmaceutical consumption, reductions in sleep 
and eating, generalized anxiety, and greater dissatisfaction. 2–8 
Child Life Magnetic Resonance Imaging (MRI) Simulations 
The literature suggests that approximately 50-to-75% of all patients who undergo MRI 
exams at pediatric hospitals are sedated.9 CLS reduce sedation rates by exposing 
pediatric patients to MRI simulations, thus alleviating symptoms of pre-procedural anxiety 
and distress. MRI simulations include mock scans that appear and sound identical to the 
real MRI, but lack the magnet, and thus functionality to take images. It’s suggested that 
preparation programs like this can reduce sedation rates by about 20% (those who are 
eligible, recruited, and successful).9  
Between November 2017 and January 2019, approximately 377 of the pediatric patients 
attending BCCH for MRI were eligible and referred for preparation with a CLS. Of the 
patients who proceeded with simulation (N=344), 82% were able to successfully be 
converted to a non-sedated MRI (Table 2).  
Table 2. Simulation statistics from BC Children’s Hospital (BCCH) Child Life Department, 
Nov2017 – Jan2019.  
 
Non-Sedated MRI 
Sedated MRI 
Passed Simulator 
283 
8 
Failed Simulator 
0 
53 
TOTAL 
283 
61 
 
It is evident from the literature and our own hospital data that CLS preparation is effective 
in reducing anxiety, non-compliant behaviors, and sedation rates.9 At BCCH, children 
under the age of 7 who wish to have a non-sedated MRI must pass an MRI simulator with 
a CLS. However, the patient’s ability to prepare with a CLS can be impacted by 
geographical barriers and socioeconomic status. Transportation barriers have been 
repeatedly identified in the literature and by parents as a source of unmet health needs 
for children in both rural and inner-city populations.10 This is significant, because if a 
caregiver cannot get their child to the MRI simulation, they miss the opportunity for a non-
sedated MRI, and consequently that increases resources and the risk for complications. 
 

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How can digital intervention help to improve access? 
Given the effectiveness of CLS preparation programs on the success of non-sedated 
MRI9 and the promising evidence that immersive technologies can effectively reduce pre-
procedural anxiety and non-compliant behaviors,11,12,21,13–20 we sought to make quality 
improvements and adjustments to the MRI experience by developing and evaluating a 
multisensory, realistic, and vivid virtual preparation program. Immersive VR experiences 
create a three-dimensional image that appears to surround the user. Complimented by 
high visual and sound quality, motion sensors, and speech recognition, VR can take input 
from users to interact with a highly realistic and vivid virtual environment. As such, our 
virtual MRI preparation program has the capacity to expose patients to experiences that 
mimic medical imaging procedures without the financial and physical limitations 
associated with traditional in-person simulation. Finding effective solutions for patients 
with geographical barriers and lower socioeconomic status are worthwhile in reducing 
sedation rates, increasing cost-savings and improving hospital efficiency. 
Project Purpose 
The goal is to improve access to effective preparatory resources for non-sedated MRI. 
Before initiating this project, we conducted a literature review to identify the existing 
evidence that supports the potential benefits and risks of immersive technologies used 
for preparation of medical procedures in general. Further, to help discover where and how 
the program could work, we developed an alpha prototype (V0.1) of the MRI environment. 
From these tasks, we observed the basic principles of developing a virtual simulation 
program for medical procedures, of which will inform this project.  
This project plan focuses on outlining the procedures for: 
1. Developing a VR simulation of the MRI experience at BCCH; and 
2. Evaluating the effectiveness of the VR simulation in preparing patients for a 
simulated MRI experience; and 
3. Modelling the costs and benefits associated with VR as compared to current 
programs, to estimate the impact and overall cost-benefit of this new intervention. 
4.0 
Methods 
4.1 
Key Question(s) 
1. Can a virtual reality simulation effectively prepare children for a non-sedated MRI? 
 
2. What are the economic and performance impacts of integrating this innovation into 
clinical operations? (at the hospital and health-systems level). 
 
3. What are the estimated socioeconomic benefits to patients and families of this 
innovation, in comparison to the status quo model? 
 
 
 
 

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4.2 
Objectives and Hypotheses 
Phase 1: Design and Development of the Virtual Reality Experience 
1. Work with an interdisciplinary team to collaboratively develop an engaging 
prototype (V1.0) that models the MRI environment and experience at BCCH. 
 
Phase 2: Technology Evaluation and Comparative Assessment 
2. Evaluate the effectiveness in pre-procedural preparation through a comparative 
assessment against other modes of delivery currently offered at BCCH – including 
pre-procedural instructional booklet, and mock MRI with CLS. 
a. Hypothesis: There will be differences in outcomes between the virtual reality 
group and the booklet group. 
b. Hypothesis: There will be no difference in outcomes between the mock MRI 
and virtual reality simulation groups. 
c. Hypothesis: Children will prefer the virtual reality and simulation exercises 
to booklet preparation. 
 
Phase 3: Economic Evaluation and Impact Modeling  
3. Evaluate costs and benefits of the VR solution and status quo; and conduct 
economic modelling on the prospective impact of operational integration.   
  
4.3 
Phase 1: Design and Development of the Virtual Reality Experience 
Objective 1: Work with an interdisciplinary team to collaboratively develop a 
prototype that simulates the MRI environment and experience at BCCH in VR. 
The media will be co-developed with a multidisciplinary team of stakeholders, including 
patient and family partners. Considerations for designing the resource have been 
informed by Gitlin (2013).22 In principle, the developed media will integrate an animated 
character that will guide the user through a series of tasks. The user will be encouraged 
to pivot, rotate, and semi-independently explore the virtual environment. The virtual 
environment will be created using any combination of 360 video and UNITY, a cross-
platform game engine used for 3D environments (Table 3).

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Table 3. Considerations for designing the VR media, adapted from Gitlin (2013).22 
Domain 
Program Elements 
Target of Intervention 
Individual 
Family and social network 
Area Targeted 
Reduce anxiety and non-compliant behaviours that 
necessitate sedation 
Increase knowledge about the MRI procedure and 
environment 
Improve skills required for successful MRI (e.g. 
holding breath) 
Delivery Technique 
Multiple iterations, tailored to children of different age 
groups (4-12 and 13-18 years) and their caregivers 
Needs assessment driven 
State of intervening 
Prevention of sedation 
Delivery mode 
Virtual Reality 
Booklet  
Mock MRI 
Dose and intensity 
Frequency of contact (TBD) 
Length of time engaging (TBD) 
Immediate and potential delivery 
setting 
Hospital, clinic, or medical office (immediate) 
Mobile technology (immediate) 
Home (potential) 
Community (potential)  
Characteristics of interventionists 
Self-Guided delivery 
Potential funding streams to 
support the intervention if proven 
effective 
Costs associated with training (TBD) 
Costs associated with technology (TBD) 
Cost benefit to healthcare systems (TBD)  
We have elected to use Google Pixel and MERGE VR as primary deployment hardware 
due to its balance of quality and affordability, given this specific use-case. The use of a 
mobile phone to view the content will allow for use in more affordable VR mechanisms in 
the future (i.e. Google Cardboard, a self-assembly cardboard version of a VR viewer), 
and easy transport to community or home-based settings (i.e. Cardboard mechanism is 
sent with instructions to end-users to assemble and launch app on their personal device 
at home).  Movement throughout the platform will be facilitated through one (or a 
combination) of the following options, decided in collaboration with stakeholders: 
1. Continuous Motion: the user has no control of travel 
2. Magnetic Switch: the user can be stopped and started using a toggle switch 
3. Bluetooth Controller: the user is in direct control of forward and backward travel 

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The program will be designed and continuously evaluated using the Plan-Do-Study-Act 
(PDSA) cycle, and created in the steps following the Technology Readiness Scale 
(TRL).23 Specifically, our project focuses on progressing through phases 2 through 5 
(Figure 1). 
 
 
Figure 1. Technology Readiness Level scale.23 
The Virtual Reality Simulation 
The VR intervention is underpinned by experiential learning and social cognitive theory, 
such that experience and accomplishments obtained through observation of successful 
performance and simulation in the VR experience will encourage imitation and reinforce 
success in the real MRI experience.24 The VR tour will introduce and explain the 
preparation and procedure of MRI scans within the BCCH medical imaging centre. Users 
will be able to turn, pivot, and explore the virtual room. The video will be at an appropriate 
length to ensure the pace can be followed by younger children, but will allow users to 
pause or stop at any point, to reduce the potential for motion sickness, headaches, or 
dizziness.17  
Patients and families will be directly involved in the development of the resource to ensure 
the content is effectively tailored, relevant, and generalizable to practice settings. An 
advisory group will be developed to help guide this project and support content 
development and clinical validation – group membership includes Child Life Specialists, 
1
• Basic principles of the concept are observed and reported
• Research from the needs assessment is translated into applied research and development
2
• The program concept is formulated through storyboarding
• Once the basic principles are observed, the practical application is created.
3
• Proof of concept
• Active research and development is initiated and components of the application are integrated.
4
• Validation in a laboratory environment
• Basic components are integrated to ensure they work together
5
• Validation in a simulated environment
• Basic components are integrated to ensure they work together in the simulated environment
6
• Prototype demonstration in a simulated environment
• A model protocol represents the near desired configuration and is tested in the operational environment
7
• Prototype is ready for demonstration in an appropriate operational environment
8
• Actual technology completed and qualified through tests and demonstrations
• Technology is proven to work in its final form and under expected conditions
9
• Actual technology proven through successful deployment in an operational setting
• Technology is in its final form and functions under real-life conditions

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Physicians, Nurses, Psychologists, Health Literacy Specialists, Media Developers, and 
others (to be determined).  
Any medical staff depicted in the virtual world will be dressed in common professional 
attire to improve realism. An animated character will guide the user in the tour. Filming 
will be dependent on access to resources, but will likely be carried out using GoPro Fusion 
(360-degree camera) in the medical imaging facility at BCCH. The video components will 
then be stitched together, and the VR tour will be available using a variety of low-cost VR 
systems, accessible through a public-facing website. Since filming will occur in the 
hospital, it may occur over multiple iterations to ensure that patients and/or medical 
records are not inadvertently filmed. 
To promote the self-guided nature of our proposed delivery, the virtual interaction will 
begin with a tutorial explaining how to use the application. When ready, users will be 
invited to be virtually guided through the MRI procedure. They will be able to pause the 
experience at any time. The content may include experiences such as: 
1. Entering the medical imaging facility 
2. Preparing for the scan (e.g. changing into a gown, checking height/weight, 
removing metal) 
3. Additional information will be provided about the procedure, including: 
- 
What MRI is and the sounds it will make 
- 
The importance of staying still 
- 
What intravenous contrast (GAD) is 
- 
What equipment to expect 
i. Knee coils 
ii. Head coil 
iii. Hand coils 
iv. Foot coils 
v. Leg coils 
vi. Body coils 
vii. Shoulder coils 
viii. Seatbelts 
- 
Other information, as identified 
4. Receiving numbing cream, and an IV 
5. Choosing if they want to be accompanied during the scan 
6. The two MRI rooms 
7. The opportunity to freely explore the room and medical devices, such as the MRI 
machine, the patient table, the murals on the walls, types of coils, and straps. 
The character will also guide the user through the MRI sequence. Content may include: 
1. Wearing ear protection and headsets 
2. Watching a movie 
3. Talking to the MRI Technologist out loud 
4. Using the emergency call bell, if required 
5. The control room where the Technologist goes 
6. Laying on the table and being strapped into place using the coils and seatbelts 
7. Entering into the bore of the MRI machine 

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8. The red light used to center the patient’s body for the pictures 
9. Starting and completing the scan (i.e. wait a pre-designated amount of time inside 
the bore, before easing the patient outside the scanner). 
10. Receiving intravenous contrast liquid (if applicable) 
4.4 
Phase 2: Technology Evaluation and Comparative Assessment  
Objective 2: Evaluate the effectiveness of the VR simulation in preparing patients 
for MRI, and compare to other modalities (i.e. booklet, simulation with CLS).  
Protocol for Evaluating the Virtual Reality MRI Simulator 
The goal of Phase 2 is to evaluate the effectiveness of the intervention on the basis of its 
ability to prepare patients and families for the MRI procedure. To do so, this phase will 
establish evidence to investigate whether the VR intervention can be implemented to 
reduce anxiety and efficiently prepare children for non-sedated MRI scans. Our needs 
assessment has identified that new accessible behavioral interventions are both needed 
and desired to alleviate the anxiety and lack of preparation necessitating sedation during 
medical imaging with children who live afar, who are not mobile, and who need extra 
practice. Virtual preparation is a promising practice that has been found to be safe, 
feasible, and acceptable in multiple clinical care settings.12,13,16,20,25   
The project evaluation plan consists of comparing the current modes of delivery through 
an objective assessment of movement and inquiry into the acceptability and utility of the 
intervention components, including potential barriers to adherence or behavioral change 
that could have unintended consequences. This information will help to generate 
knowledge that can be used to refine the current prototype and support future innovation 
in this domain at BCCH (Phase 4, not included in this proposal). 

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Figure 2. Evaluation design. 
The recruitment strategy has been informed by the literature on recruitment in pediatric 
research settings.26–28 The design and expansion of the recruitment strategy has enacted 
as a response to the low enrollment rate arising from traditional strategies (posters that 
we had initially proposed). Participants will be recruited through: 
- 
Advertisements, flyers, internet postings and/or social media through the 
Digital Lab website (www.bcchdigital.ca), the BCCHRI website, social media, 
and through hospital and community recruitment boards. Community focused 
recruitment will include flyers and posters distributed to various public places such 
as local supermarkets, children’s stores, playgrounds, clinics, and coffee shops 
with applicable advertisement boards for community postings. The use of 
Facebook Ads has been emerging in the literature as a recruitment strategy. A 
typical ad will be comprised of a succinct description about the research with a 
hyperlink that directs the Facebook user to the recruitment poster with more 
information about the study’s eligibility criteria, compensation, and enrolment 
instructions.29 Our ad was designed following the recommendations of Wozney et 
al. (2019) who recommend in video format. Our content was selected to appeal to 
caregivers of children between 4 to 13 years. Audience targeted fields in the 
Facebook ad manager will be selected to show ads to users with specific interests 
and demographics (e.g. children between the ages of 4 and 13, located in 

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Vancouver, BC). Facebook analytics will be used to track actions related to the 
ads.  
- 
Direct recruitment of potential study participants through clinical staff at the 
Hospital (BCCH) talking with their own or clinic patients about the study 
and/or contact between the study team and the potential participants on the 
phone or via email. Any initial contact made by our study will be by someone who 
is thoroughly knowledgeable about the study, able to answer questions, and 
trained in the voluntary nature of the research participation. 
Parents/participants will be invited to initiate participation in the evaluation by emailing 
or calling the Research Manager (chelsea.stunden@ubc.ca; 604-875-2345 ext. 6512). 
The study parameters will be reviewed with the prospective participants, and informed 
consent will be emailed to the participant. Verbal consent (provided over the phone or 
through email) will be obtained to initial allocation, and written informed consent (parent 
or guardian) and assent (participant over 7 years) will follow in-person. Participants will 
be reimbursed for parking and provided snacks and refreshments during inactive 
segments of the evaluation process. A $20 remuneration will be provided to each 
participant for their time volunteering in the study components. 
 
A minimum of 93 participants (31 participants per group) aged 4-to-13 will be recruited 
through convenience sampling, consented, and randomized by staff to one-of-three 
preparation programs (VR, mock MRI, or booklet). Details of the comparison groups are 
outlined in Table 4. Given the restricted availability of the simulator, child life specialists, 
and the availability of participants, we are unable to fully randomly allocate participants. 
As such, participants will be randomly assigned to the intervention options available 
according 
to 
their 
individual 
availability 
(using 
Research 
Randomizer 
https://www.randomizer.org/).  For example, if a participant is available on a Thursday 
that virtual reality and booklet are available, they will be randomly allocated to one of 
these interventions.  
This phase will have open recruitment to all children and adolescents interested in 
participating, such that participants may not be BCCH patients scheduled for an MRI. This 
recruitment strategy was selected due to the resource constraints associated with limiting 
the evaluation group to MRI patients only. 
Table 4. Details of the comparison groups. 
 
VR Simulation 
MRI Preparation 
Booklet 
 
Mock MRI 
Facilitator 
Research Assistant 
Research Assistant 
Child Life Specialist 
Location 
BCCH 
BCCH 
Simulation Room 
Content 
Refer to 
The Virtual Reality 
Simulation 
Refer to 
MRI Preparation 
Book 
Individualized 
intervention in 
physical simulator.  
 

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The different interventions will be held in separate private rooms located in BCCH, such 
that the VR and booklet groups will not have prior exposure to the imaging centre or the 
simulation room in advance of their assessment. This is to simulate our intended delivery 
in hospital, medical office, or clinic settings but minimize alternative explanations 
associated with testing in the simulation room where assessments will take place 
(previously described in Table 3).  
Data will be collected throughout the implementation process (Figure 3). The predictive 
variables (demographics and relevant history, and delivery type) will be captured at the 
start of the session. The primary outcome variable is likelihood of success (pass/fail) of 
the MRI simulation, and will be measured at the end of the assessment. Anxiety will also 
be measured at three time points. Usability testing will be conducted throughout to 
capture possible quality improvements and amendments to each of the program delivery 
modes. 
Inclusion/Exclusion Criteria 
Participants must be between the ages of 4-to-13 years to be included in the evaluation. 
The following exclusion criteria, which have been noted in previous studies conducted 
using virtual reality programs, will be adopted for this project: 
• mental disability (content not appropriate) 
• significant visual and auditory impairment (this program focuses on auditory and 
visual cues) 
• inability to speak or understand English (content and study staff are English 
speaking) 
• history of seizures or epilepsy (triggered by virtual reality) 
• facial or head wounds (cannot wear the virtual reality headset) 
 

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Implementation Plan 
 
Figure 3. Implementation process.

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The testing phase of the implementation process, depicted in Figure 3 will be completed 
over two hours, and will involve the following steps: 
1) Participants and parents/guardians are greeted by staff and enter the intervention 
room. 
2) Staff will obtain written consent from parents and verbal assent from children (5 
minutes). 
3) Participants will complete the Venham Picture Test (VPT) with staff (pre-test). In 
parallel, parents will complete the Short STAI on the iPad. (5 minutes) 
4) Staff will reveal the allocated delivery mode (VR, mock MRI, or booklet) to the 
participant and explain the procedure. 
5) Staff will ask participants to indicate on the Smileyometer how good they think the 
intervention is going to be.30,31 This will give a measure of expectation that can 
indicate whether or not the participant is subsequently let down by the activity or 
pleasantly surprised. 
6) Staff will measure the participant’s interpupillary distance using sliding calipers. 
7) Participants will be given 45 active minutes to engage with the intervention. Groups 
include: 
Group 1 (VR): The VR group will receive a virtual reality simulation 
designed during Phase 1 of this study. 
Group 2 (mock MRI): The mock MRI will be provided by the CLS, according 
to the current care plan which consists of exposing children to the mock 
MRI, medical devices, and procedures. The mock MRI is located within the 
BCCH medical imaging facility. 
Group 3 (booklet): The standard MRI preparation booklet group will 
provide access to a series of printed photos and text showing the MRI 
experience step-by-step to help prepare for the MRI.  
8) Participants will be asked to indicate on the Smileyometer how good they actually 
thought the activity was overall (1 minute). 
9) Participants will be informed that they will now be completing a simulation test with 
the MRI scanner. Participants will be reminded of their free and informed ongoing 
consent.  
10) The participant will be transferred to the simulation room, located in the medical 
imaging center at BCCH. Upon entering the simulation room, participants will 
verbally complete the VPT with staff (during test). In parallel, parents will complete 
the Short STAI on the iPad. (5 minutes)  
11) Participants will be guided through a mock MRI and be assessed using MoTrack®, 
an objective head motion tracking system.32 The simulation will be completed over 
20 minutes and will involve progression through the “MRI procedure”, remaining in 
the bore for 8 minutes. All participants will receive the same type of simulated scan. 
We will not be simulating any invasive procedures that can sometimes occur during 
the MRI (i.e. an IV or intravenous contrast liquid). Please note that this assessment 
involves a mock procedure using the simulator, not a real MRI.  
12) Immediately following the simulation, participants will verbally complete the VPT 
with staff (post-test). In parallel, parents will complete the Short STAI on the iPad. 
(10 minutes).  

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13) Users will be asked to indicate on the Smileyometer how they thought the 
preparation activity was overall in preparing them for the MRI. Parents/guardians 
will be asked to complete the USE Questionnaire. 
14) Staff will ask the user open-ended questions on the preparation materials 
according to three separate criteria of fun, ease of use, and how good it was for 
learning about the MRI experience. The final usability assessment will take a total 
of 10 minutes.  
15) After the session is "complete", children will be told that they "happen to have some 
time left" so they can play with any of the preparation materials offered (VR, Mock 
MRI, Booklet) for 5-minutes if they want to "because they did so well during the 
activity." This will give children a natural choice selection and will be used to gauge 
preferences for the activities.  
16) A verbal session debrief will include an opportunity for questions to mitigate any 
residual feelings of discomfort or anxiety that may arise from the project’s activities.  
Outcome Measures 
The measures used to evaluate the intended outputs and outcomes associated with this 
project are outlined below (Table 4). 
 
Table 4. Outputs and outcomes associated with the project. 
Measure 
Immediate Outputs 
Intended Outcome 
Primary 
MoTrak®  
# of participants “prepared” to be 
scheduled for an effective MRI  
Improve access to MRI 
preparation for children who: 
- 
Live out of town 
- 
Would like to practice 
skills at home 
- 
Have mobility issues  
Improve non-sedation rates for 
MRI scans. 
Venham Pictoral 
Test & Short STAI 
# of participants with reduced 
anxiety 
# of parents with reduced anxiety 
Improve access to MRI 
preparation materials. 
Improve behavioral 
compliance during medical 
procedures. 
Secondary 
Smileyometer 
# of participants who find the 
delivery mode fun and engaging to 
use 
Improve acceptability of 
preparation materials. 
Improve satisfaction. 
USE Questionnaire 
# of parents who find the preparation 
materials useful 
Improve acceptability of 
preparation materials. 
Improve satisfaction. 

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Natural Choice 
Selection 
# of participants who select the 
booklet 
# of participants who select the mock 
MRI 
# of participants who select virtual 
reality 
# of participants who select none 
Identify preference for 
engaging.  
Identify frequency of contact 
and time engaging. 
Length of Stay 
Minutes spent per segment 
Improve hospital efficiency 
Guided Survey 
# of participants who find the booklet 
fun, easy to use, and good for 
learning about the MRI experience  
# of participants who find the mock 
MRI fun, easy of use, and good for 
learning about the MRI experience 
# of participants who find the virtual 
reality game fun, easy of use, and 
good for learning about the MRI 
experience 
Improve utility of MRI 
preparation materials. 
Identify frequency of contact 
and time engaging. 
Interpupillary 
Distance 
Average interpupillary distance per 
age 
Improve headset configuration. 
 
Primary Measures 
Predictive Success in Avoiding Sedation 
The predictive success in avoiding sedation will be measured using Motrak® software 
assessment. MoTrak® uses a sensor attached to the participant’s head to determine the 
position of the head in space relative to a transmitter located within the simulator. The 
sensor records angular rotations as well as positional displacements from an initially 
calibrated position. This information is displayed and logged by the program in real-time, 
allowing objective observation of head motion in an MRI simulator.32 The fail threshold is 
set at 3mm of movement in any of the positional displacements (x,y,z), which is in 
accordance with imaging protocols at the Hospital. 
Child Anxiety: Venham Picture Test – 5 minutes 
Anxiety assessment with children will be completed in pictorial form to better adapt to 
the cognitive and communicative abilities and styles of younger children. The Venham 
Picture Test has been well-validated in children for assessing procedural anxiety33,34, 
and comprises eight cards which two figures on each card, one anxious character and 
one non-anxious character. The children will be asked to point at the figure they feel 
most like at that moment. All cards will be shown in their number order. If the child 
points at the anxious figure, a score of one is recorded and if the child points at the non-
anxious character, they will be given a score of zero. Children will complete the at three 
timepoints (before, during, after the mock MRI). 
 

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Secondary Measures 
Parental Anxiety: Short State-Trait Anxiety Inventory (Short STAI) – 5 minutes 
Anxiety assessment with parents/guardians and children at baseline, after completing the 
intervention, and before the mock MRI. The Short STAI is a 6-item, adapted version of 
the well-validated Spielberger State-Trait Anxiety Inventory Scale.35 It distinguishes 
between general proneness to anxious behavior rooted in the personality and anxiety 
connected to a current state, and has been validated for use in children.35  
Demographics and Relevant History 
Demographic and possible confounding information (age, sex, prior experience with 
medical imaging, experience with virtual reality, type of mobile phone) will be obtained 
through a data collection form. Data will be de-identified using a participant identification 
number.  
Length of Stay (LoS)  
For the purposes of this evaluation, we will define total LoS as the duration, in minutes, 
from starting the preparation segment to completion of the simulated assessment. Inter-
segment times will also be recorded. Preparation time will be capped at 45 minutes. 
Assessment time will be capped at 20 minutes. Start of preparation will be noted as time 
when study staff finish describing the intervention and indicate it is time to begin the active 
preparation. Time will stop when the participant is “discharged” from the MRI simulation, 
before the natural choice selection exercise and debriefing process begins. Time spent 
transitioning between activities or breaks required for reasons unrelated to the evaluation 
will not be counted towards overall LoS.  
Interpupillary Distance 
Interpupillary Distance will assume normal conditions and be measured objectively before 
preparation using Pryor’s (1969) method36 to ensure appropriate set up of the virtual 
reality device. 
 

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Usability Testing 
The Smileyometer – 1 minute 
The Smileyometer30,31 is an instrument used for measuring the opinions of technology in 
children, and has been validated in multiple studies assessing educational materials and 
software. The Smileyometer is based on the Visual Analogue Scale,37 consisting of a 5-
point Likert scale that uses pictorial representations. Participants are asked to point to the 
face they relate to. 
Guided Survey – 10 minutes 
The RA will ask the participant several open-ended questions on the preparation 
materials according to three separate criteria of fun, ease of use, and how good it was for 
learning about the MRI experience.  
USE Questionnaire – 10 minutes 
The USE Questionnaire23 will be administered to the parents/guardians after the mock 
MRI only. This will allow participants to compare the VR application to the “effective MRI” 
experience. The USE Questionnaire is a 7-point Likert rating scale that has been well-
validated to assess a program’s usefulness, ease-of-use, ease of learning, and 
satisfaction.  
Analysis and Interpretation 
A priori power analysis was calculated using G-Power.38 A total sample size (N) of 93 was 
calculated to be needed across the 3 groups (31 per group), with a significance level of 
95% (a=0.05) and a power of 90% (B=0.10), allowing for a 10% drop out rate. An effect 
size of 0.2 was selected to reflect the research suggesting that CLS preparation can 
reduce sedation rates by 20%.  
Descriptive analysis will be conducted on the demographics and relevant history data. 
Differences in predictive success of the MRI simulation ranking scores (pass or fail) will 
be examined using a Repeated Measures ANOVA, within-between interaction for three 
timepoint measurements (before, during, after) of anxiety and delivery type (VR, mock 
MRI, booklet). In the case of an off-normal distribution, non-parametric tests may be used. 
Multivariate analysis will test for possible confounding effects (demographics and relevant 
history). 
Survey data (USE questionnaire, Smileyometer) will be analyzed using means and 
standard deviations of all respondents for each category of the questionnaires. The 
proportions of the participants reporting high, medium, or low levels will also be 
calculated. 
Study staff will document responses to the guided survey and read the recorded answers 
back to participants to verify accuracy and elicit possible further reflection. All of the 
qualitative data will be uploaded to NVivo by study staff. When complete, study staff will 
code the information to identify major themes, gaps, barriers within the existing approach 
and the team will devise recommendations for improving the preparation programs. The 
phases of this process include: 
- 
Familiarizing yourself with the data 

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- 
Generating initial codes 
- 
Searching for themes 
- 
Reviewing themes 
- 
Defining and naming the themes 
- 
Triangulation with other findings and producing a report 
4.5 
Phase 3: Economic Evaluation and Impact Modelling 
Objective 3: Evaluate costs and benefits of the VR solution and status quo; and 
conduct economic modelling on the prospective impact of operational integration.   
The final phase of this project seeks to answer the following questions: 
• What are the current costs of Sedated and Non-Sedated MRI procedures at BC 
Children’s Hospital? (including hospital/health systems costs and average 
economic burden on patients and families). 
• What is the total cost avoidance and opportunity-cost savings in converting a 
sedated case to a non-sedated case? 
• What is the cost-effectiveness of current interventional strategies? 
• What is the potential incremental cost-effectiveness ratio of the VR simulation 
compared to the status quo model (given known limitations)? 
• What are the relative impacts to patient/families, hospital, and the health system 
at large of the various interventions? 
The economic modelling will be conducted in a series of stages: (1) cost analysis, (2) 
outcomes (benefits) analysis, and (3) multi-level modelling of cost-effectiveness (from 
patient/family, hospital, health systems perspectives). 
 
Stage 1: Cost Analysis 
Costs will be analyzed from the perspective of the program implementer (hospital) and 
estimated for patients/families, and will be reported in Canadian dollars.  
For hospital costs, we will analyze administrative/operational costs and clinical volume to 
present an average case cost for the status quo model and intervention groups. Program 
costs will be categorized into capital and operational costs, and segmented as 
technology, administrative, operational and resource costs: 
- 
Technology costs will include hardware devices, technology-related consumables, 
and technical support. Capital costs for the media development will be measured 
for the purposes of a parallel return on investment (ROI) analysis, but will be 
excluded from operational cost-effectiveness analysis (CEA), with the assumption 
that in many scenarios existing media may be available for use. Multiple CEA 
models will be produced at varying media costs thresholds, simulating custom 
content development (using actual incurred/in-kind costs) as well as estimated 
costs for ‘off-the-shelf’ media procurement (based on current state market pricing). 
- 
Administrative, Operational and Resources costs will include program 
management, infrastructure, human resources (e.g. child life specialists, 
physicians, technologists), medications, associated resources, and consumable 
supplies. 

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When presenting the description of the program costs, we will break the components into 
fixed and variable costs. Fixed costs are defined as not varying, or varying minimally, with 
the volume of users and variable costs will be tied to the number of users. Fixed costs 
may include technology, administrative support, staff, and promotional costs. Variable 
costs may include consumables and medication. 
Time-Driven Activity Based Costing (TDABC) 
For the analysis of human resources costs, the TDABC methodology will be used to 
assign costs based on relative resource utilization. TDABC combines business process 
mapping with detailed assessment of time intervals and resource involvement. The unit 
cost for each resource will be derived from our review of hospital financial, operational, 
and clinical volume data (defined as per minute resource costs). Unit costs (per minute 
estimates) will be multiplied by the relevant time estimate of the activity (or component 
of), segmented by task and resource.  
- 
The per minute unit costs of supplying the capacity will be derived by dividing 
the total annual costs of individual resources by the minimum annual hours of 
service. This information will be derived from our review of hospital financial, 
operational, and clinical volume data. 
- 
Time estimates for relevant tasks associated with the programs will be derived 
from our LoS data and process mapping information gathered in Phase 2  
To estimate patient and family costs, multiple scenarios will be defined based on 
scheduling and administrative data available the Medical Imaging and Child Life 
Department. No personally identifiable information will be used in any modelling of patient 
and family costs. Through an analysis of administrative data, we will determine average 
length of stay for current MRI patients (simulation and actual imaging). Patient/Family 
costs will be estimated to include opportunity cost (of time spent), travel and 
accommodation (where applicable – e.g. when simulation and actual imaging are on 
different dates).  
Stage 2: Outcomes (Effects) Analysis 
Outcomes will be reported at both the hospital and patient/family perspective, based on 
the data gathered in Phase 2 (Table 4); this includes the predictive non-sedation rates, 
length of hospital stay, and reductions in anxiety from the patient and family perspectives.  
Stage 3: Multi-Level Cost-Effectiveness Modelling 
Cost-Effectiveness will be modelled across the various scenarios identified and from 
multiple perspectives (i.e. hospital, patient/family). To support decision-making, we will 
determine the incremental cost-effectiveness ratio (ICER) of the intervention versus 
the control. ICER is a statistic used to summarise the cost-effectiveness, and is defined 
by the difference in cost between two possible interventions, divided by the difference in 
their effect; this represents the average incremental cost associated with 1 additional unit 
of the measure of effect. For our study, we will measure ICERS for multiple outcome 
variables that are measured in Phase 2. 

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Uncertainty Analysis 
We expect the number of users, the average amount of consumables and equipment 
used, and the amount spent on promotional costs to fluctuate. Therefore, we will conduct 
a probabilistic uncertainty analysis around these program variables to determine 
sensitivity and what the expected range of cost-effectiveness might be. These values and 
distribution for the uncertainty analysis will be selected based on one-year data. 

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