Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients
Phase: NA
Conditions: Chronic Pain, Cancer
Sponsor: University of British Columbia

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
1 
Immersive Multimedia as an Adjunctive Measure for Pain Control in 
Cancer Patients Research Protocol and Statistical Analysis Plan 
Title 
Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer 
Patients 
Trial registration  
Registered on 16/12/2016 at 
https://clinicaltrials.gov/ct2/show/NCT02995434?term=NCT02995434&dr
aw=2&rank=1  Registration #: NCT02995434 
Protocol version  
1.0 (Last Updated: May 15, 2023) 
Funding 
Lotte and John Hecht Memorial Foundation for their funding to conduct 
this research (Grant ID: 4110). https://www.hecht.org/  
Author details  
Dr. Bernie Garret. Professor, University of BriƟsh Columbia, School of 
Nursing, BC, Vancouver, Canada 
Dr. Tarnia Taverner, Adjunct Professor, University of BriƟsh Columbia, 
School of Nursing, Vancouver, BC, Canada  
Dr. Diane Gromala, Professor, Simon Fraser University, School of InteracƟve 
Arts and Technology, Vancouver, BC, Canada 
 
Name and contact 
information for the 
trial sponsor  
Alona Nakonechnaya, Grants Manager, 
Lote and John Hecht Memorial FoundaƟon 
Email: ANakonechnaya@hecht.org  
Role of sponsor  
The sponsor had no role in the design, implementaƟon, analysis, reporƟng 
of the results and disseminaƟon of ﬁndings of this study. 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
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Title: Immersive Multimedia as an Adjunctive Measure for Pain 
Control in Cancer Patients Research Protocol and Statistical Analysis 
Plan 
 
Names protocol contributors 
Dr. Bernie Garret. Professor, University of BriƟsh Columbia, School of Nursing, Vancouver, Canada 
Dr. Tarnia Taverner, Adjunct Professor, University of BriƟsh Columbia, School of Nursing. Vancouver, 
Canada  
Dr. Diane Gromala, Professor, Simon Fraser University, School of InteracƟve Arts and Technology, 
Vancouver, Canada 
 
Abstract 
Background: Despite the growing popularity and affordability of virtual reality (VR), as adjunctive 
nonpharmacological interventions (NPIs) for chronic pain, there have been a few trials for effectiveness. 
his randomized controlled superiority trial, examined the effects of a home-based adjunctive VR NPI for 
chronic pain in cancer patients, compared to the same NPI experienced through a two-dimensional (2D) 
computer screen. 
Trial Design:  A parallel two arm participant blinded prospective superiority randomized controlled trial 
(RCT) with 1:1 allocation.  
Methods: 
• 
Participants - Community-dwelling adults with cancer-related chronic pain. 
• 
Interventions- Home-based pain therapy through 4 applications involving cognitive distraction and 
mindfulness meditation for 30mins/day, 6 sequential days per applications for 4 weeks, either using 
VR or a 2D laptop.  
• 
Objective - Determine to what extent virtual reality (VR) based applications are advantageous for 
daily home-based chronic cancer pain management compared to equivalent applications 
experienced on two-dimensional (2D) computer screens.  
• 
Primary Outcomes - Daily and weekly pain scores measured via the Visual Analog Scale (VAS) and 
the Short Form McGill Pain Questionnaire (SF-MPQ).  
• 
Secondary Outcomes - Weekly quality of Life (SF-12), and sleep quality (Pittsburgh Sleep Quality 
Index) were measured. 
• 
Randomization - Used a Latin Square design (blocks of 12) to randomize participant arm allocation 
and sequence of applications experienced. 
• 
Blinding - Single blinded (participants were blinded to which NPI they received). 
Trial registration: Registered on 16/12/2016 at 
https://clinicaltrials.gov/ct2/show/NCT02995434?term=NCT02995434&draw=2&rank=1  Registration #: 
NCT02995434  
 
Keywords 
Chronic pain, virtual reality, chronic pain, cancer, cognitive distraction and mindfulness meditation. 
 
 
 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
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Introduction 
Background and rationale  
This study sought to explore the efficacy of virtual reality (VR) as a practical therapeutic intervention in 
the self-management of the chronic pain associated with cancer survival. This work will inform further 
clinical studies and future research into the potential uses of VR in the treatment of cancer associated 
pain. Furthermore, it will help identify optimal VR environments for use in chronic pain applications, 
practical determinants for implementation of VR for wider practice, and will provide a better theoretical 
understanding of the mechanisms whereby VR works in chronic pain. Work in this area is in its infancy; 
VR represents a new technology that has many novel applications. Its value for pain control appears very 
promising and original clinical work is now essential to establish efficacy and optimal approaches. This 
proposal builds on results from our current pilot work, and review feedback.  
 
Cancer survivorship refers to individuals who have remained cancer free for a minimum of 5 years.1   
Due to developments and greater outcomes associated with cancer therapy and management, the 
number of individuals who survive cancer has risen considerably over the past decade. Currently, 65% of 
adults and 80% of children can be expected to live at least 5 years post cancer diagnosis.2 However, for 
some, survivorship is associated with debilitating chronic pain which impacts negatively on quality of 
life. Reviews have suggested that up to 40% of individuals have survived cancer remain with cancer 
related chronic pain.3 Compounding this, chronic pain is poorly managed in Canada, and many patients 
are unable to access appropriate specialist treatment. Currently, in BC a conventional model underlies 
the primary provision of community-based chronic pain management, with most care being provided by 
family physicians, who refer their patients to pain management tertiary centers. However, access to 
these centers is severely limited due to capacity; a Canadian survey identified that six months was the 
median wait time, with more than 30% of centers reporting a wait list of more than one year, and vast 
areas of the country remained unserved.4 While specialist pain centers management can be effective, 
this can only reach a small proportion of the chronic pain population. Furthermore, over the past couple 
of decades there has been a dramatic shift in emphasis in treatment, from treatment of acute to chronic 
disease, and more recently, the shift from physician directed management to patient self-management.5 
Novel approaches to community based patient self-management are therefore required.6 
 
VR involves the provision of a synthetic environment that is experienced by a person through interactive 
sensory stimuli (audio-visual and sometimes touch) delivered by a computer interface in which the 
participants actions partially determine what happens within the environment. VR allows individuals to 
become active participants immersed within a computer generated three-dimensional virtual world, 
thereby transforming sensory, emotional and cognitive features of their experience. The phenomenon 
of becoming engaged in a virtual reality environment provides a powerful tool for behavioral and health 
scientists/professionals. VR can be used to immerse patients into different environments psychologically 
removing them from their existing physical reality. Computer-generated three-dimensional stereoscopic 
imagery simulates a visual 3D virtual world, with visual depth cues provided by perspective, motion 
parallax, rendered 3D objects and realistic textures. A Head-Mounted Display is used to present this 
world to the user, updated in real time using head (and sometimes body tracking) to simulate the 
realistic movement of objects with the user’s motion. The 3D perspective is achieved by tracking the 
users head position so that imagery is updated from the perspective of each eye’s location. To deliver 
immersive audio, stereo headphones or speakers are used to deliver stereo audio to simulate the 
location of the sound with respect to the position of the user’s head. The combination of real-time 3D 
tracked imagery and audio presented in stereo enables the user to gain a sense of immersion and 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
4 
presence inside the virtual world. By presenting the illusion that there is a virtual 3D world everywhere 
that the user looks, a very different experience is achieved than that of watching a flat screen. 
Exploration of the value of the latest generation of HMDs (now commercially available) with VR 
environments to support chronic pain has been little explored.7 However, to date VR has been 
successfully tested in a range of clinical applications, and specifically in the treatment of acute pain, and 
with other conditions with a psychological aspect.7 Outcomes for patients using VR for clinical conditions 
such as anxiety disorders,8 phobias,9 post-traumatic stress disorder,10 eating disorders,11 and pain 
management.7  
 
VR is hypothesized to reduce pain via both active attentional and distractive mechanisms.12 Neuromatrix 
theory suggests that pain is a multidimensional experience produced by a neurosignature, patterns of 
impulses generated by a widely distributed neural network, described as the "body-self neuromatrix" in 
the brain.13 VR may work by changing the acuity of the pain modulation system by acting on the 
signaling pathways of this neuromatrix, producing an analgesic effect. Other researchers suggest that 
specific cognitive contextual mechanisms in the brain may also help mediate pain.14  
 
Engaging in a virtual reality experience may therefore, change activity in the bodies’ intricate pain 
modulation system, which in turn have an impact on pain perception. Here the anterior angulate cortex 
(ACC) region of the brain is suggested to be of particular significance in mediating pain and the ACC is 
suggested to mediate both attentional processes and emotional reactions in the personal perception of 
pain.15 Given these theories, along with rapidly emerging technologies and clinical work in this field, it 
would appear that VR may have significant potential. However currently there has been little work done 
to establish the potential use of VR in the management of chronic pain to date, most work on VR for pain 
management has focused on acute pain via distraction. Several researchers have recommended the 
investigation of VR for chronic, long term pain16,17 and the researchers are currently completing a pilot 
study to establish best methods and approaches to using VR in chronic pain conditions. 
 
Objectives  
This RCT aimed to determine to what extent VR-based applications are advantageous for daily home-
based chronic cancer pain management, compared to equivalent applications experienced on two-
dimensional (2D) computer screens. To this end, the following null hypotheses were tested:  
 
1. There is no difference between the reported daily pain experiences of participants during, or 
after exposure to VR immersive environments, overall and within four different VR immersive 
environments, compared to the equivalent applications experienced on a 2D computer screen.  
2. There is no difference in self-reported weekly pain, quality of life, and sleep experiences, of 
participants exposed to different VR immersive environments over the period of the study, 
compared to participants exposed to the equivalent applications experienced on a 2D computer 
screen.  
 
Trial design  
The study was a parallel two-arm (VR vs non-VR control) participant blinded prospective RCT with 1:1 
allocation (clinicaltrials.gov, NCT #02995434). It was primarily conducted with rolling recruitment in 
British Columbia as well as Alberta, Ontario and Quebec between August 2017 and December 2022. The 
trial was approved by the University of British Columbia Clinical Research Ethics Board (Approval #: H16-
01510), and all participants provided informed written consent.  
 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
5 
Methods: Participants, Interventions and Outcomes 
Study setting 
Community - within paƟents’ homes or residence. 
 
Eligibility criteria  
The inclusion criteria were:   
• 
Aged >16, with a past or current diagnosis of cancer   
• 
Past or current treatment with standard cancer therapies  
• 
Experiencing chronic pain (ongoing daily pain ≥ 3 months with Neuropathic Pain Fidelity Scale ≥4 out 
of 10)  
• 
Able to understand the English language (read and write)  
• 
Normal stereoscopic vision  
• 
Readily able to move head up, down, left, and right, and able to wear a headset  
• 
Have fine motor control in one hand sufficient to use a game controller  
• 
Have space at home for a computer and monitor  
 
The exclusion criteria were:   
• 
People who self-reported having significant cognitive issues, a history of seizures, claustrophobia, or 
high susceptibility to motion-sickness.  
 
Who Takes Informed Consent?  
Written consent was obtained by the project research assistant or primary/co-investigators as per 
ethical approval guidance from the UBC Behavioural Ethics Review Board from all participants before 
the trial commenced. 
 
Interventions 
Explanation for the choice of comparators  
The phenomenon of becoming engaged in a virtual reality environment has been hypothesised to 
provide a more immersive and hence more powerful diversion experience to relief pain as an adjunctive 
NPI, placing patients into different environments psychologically removing them from their existing 
physical reality. 12 The adjunctive NPI involved two established approaches to chronic pain management: 
cognitive engagement and introspective mindfulness relaxation.18,19 These activities were delivered 
through either an immersive VR system, or a laptop in the control arm. The VR equipment consisted of 
an HTC Vive (HTC, Taiwan) head mounted display (HMD) with a resolution of 1080x1200 pixels per eye, 
and 110° field of view at a 90 Hz refresh rate. Audio was delivered through the Vive Deluxe Audio Strap 
high-fidelity stereo headphones, and two hand controllers were used for application interaction, 
movement and navigation in the VR environment. Two infrared tracking modules enable 6-degrees-of-
freedom spatial motion tracking of the HMD and controllers. The desktop computer running the VR 
system included hardware sufficient to run all activities at the highest graphical settings available for the 
applications. The non-immersive control arm participants received a 17” laptop with mouse, an XBOX 
game controller, and stereo headphones.   
  
Intervention description 
The VR equipment consisted of an HTC Vive (HTC, Taiwan) head mounted display (HMD) with a 
resolution of 1080x1200 pixels per eye, and 110° field of view at a 90 Hz refresh rate. Audio was 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
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delivered through the Vive Deluxe Audio Strap high-fidelity stereo headphones, and two hand 
controllers were used for application interaction, movement and navigation in the VR environment. Two 
infrared tracking modules enable 6-degrees-of-freedom spatial motion tracking of the HMD and 
controllers. The desktop computer running the VR system included hardware sufficient to run all 
activities at the highest graphical settings available for the applications. The non-immersive control arm 
participants received a 17” laptop with mouse, an XBOX game controller, and stereo headphones.   
Two commercially available applications were used for cognitive distraction interventions. Obduction 
(OB: Cyan Ventures, Mead, USA) is a first-person adventure game that involved exploring a strange new 
environment, solving puzzles, and uncovering mysteries.   
 
The other was Cape Lucem - Seize the Light (CL: Application Systems, Heidelberg, Germany). This was a 
VR puzzle game that involved manipulating and redirecting light beams in 3D space with different pieces 
to unlock objects. Participants used hand controllers to move puzzle pieces. Carpe Lucem was 
unavailable in a suitable format for laptop use, so another geometric puzzle solving application was used 
as a substitute for the control group, The Witness (WN: Thekla, San Francisco, USA). which requires 
participants to solve various maze-based puzzles.   
 
Two mindfulness focused introspective applications were also used: Virtual Meditative Walk (VMW), 
and Wildflowers (WF). The VMW involved moving along a forested path while listening to a guided 
meditation for pain with accompanying relaxing music.20,21 There were 3 meditations in sequence, and 
interaction in this activity was limited to looking around as the participant moved along the path.   
 
The Wildflowers application involved controlling a butterfly from a third-person-perspective to explore a 
peaceful island. The participant could freely look around and control the butterfly's flight path three 
dimensionally using the controller. The application included locations for ten guided meditations, 
location-specific relaxing soundscapes, and interactive musical sculptures. Both applications were 
adapted by the developers for use in this project.  
  
Criteria for discontinuing or modifying allocated interventions  
Criteria for discontinuing included any serious adverse events as a result of the VR NPI (e.g., seizures, 
serious motion-cyber-sickness). Participants were able to change allocated NPI application (e.g., CL, WN, 
VMW, OB), if they found they provided a negative experience. 
  
Strategies to improve adherence to interventions  
ParƟcipants were required to record and notify the researchers of any change in the allocated 
applicaƟon use and encouraged not to change the sequence of allocaƟons, unless there was a signiﬁcant 
issue. Practical support was provided through simple instructional materials and walkthroughs for the 
four different applications. A help service by phone, email or teleconferencing (with remote desktop 
computer access) was also provided for participants to contact a research assistant for technical support 
or any other issues they met during the trial. Participants were encouraged to contact them if anything 
seemed problematic or if they felt stuck.   
 
Provisions for post-trial care  
None, established standard of care was not altered as no pharmacological, invasive or potentially 
harmful intervenƟons were used. 
  
 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
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Outcomes  
Primary Outcomes  
Daily and weekly pain were the primary outcomes of interest. Daily pain was assessed using the Visual 
Analogue Scale (VAS). The VAS is a single item linear self-reported pain scale from no pain (0mm) to 
worst pain imaginable (100mm). It was selected as a well-established and validated subjective measure 
for acute and chronic pain.22 The measure has demonstrated moderate-high correlation with the 
numeric pain fidelity scale (correlation coefficient from 0.62-0.91) 23 and high reliability (intraclass 
correlation coefficient = 0.97).24 The clinically meaningful change for the VAS has been shown to be 
between 9mm and 12mm; this study adopted the convention of 10mm as the minimum clinically 
important difference (MCID).25,26,27  
 
The Short Form McGill Pain Questionnaire (SF-MPQ) was used weekly to assess pain from baseline. The 
measure includes 15 items (rated not applicable, mild, moderate, severe) assessing sensory pain (11 
items) and affective pain (4 items), as well as a VAS component scored out of 10. Higher scores mean 
greater pain. This instrument is also well-validated and established in clinical use,28 and has 
demonstrated good sensitivity to change over time in chronic cancer pain.29 An MCID has not been 
established for the SF-MPQ, although a clinically important change (CIC) has been identified as a mean 
total score of >5 out of the total of 55.30,31,32 Its use here was designed to examine trends over the 4-
week period of the RCT. A brief end of trial RCT survey was also completed by participants asking if they 
found any ongoing pain relief after NPI use (and if so, and for how long), if they reduced their pain 
medication requirements, if they helped or in other ways not captured.   
 
Secondary Outcomes  
The Health Survey Short Form (SF-12) was used as a self-reported outcome measure assessing health-
related quality of life weekly.33,34 It includes 12 items with binary response items and 3-6-point Likert 
items. The SF-12 is scored using proprietary software to generate a physical composite (PCS) and mental 
composite (MCS) health scores ranged 0-100, with scores above or below 50 indicating greater or 
poorer health than normative mean, respectively. The measure has demonstrated validity (internal 
consistency αPCS12 = 0.89; αMCS12 = 0.88) and reliability (ICCPCS12 = 0.82; ICCMCS12 = 0.73) in a sample of 420 
adult cancer patients.35 MCID is smaller in patients with longer pain duration and better baseline 
quality of life, and based on prior medical studies a MCID >3.77 in the MCS and >3.29 in PCS, were 
adopted as clinically relevant for this study.36,37  
 
The Pittsburgh Sleep Quality Index (PSQI) was used as a self-reported outcome measure assessing sleep 
quality on a weekly basis.38,39 The measure includes 19 items asking about sleep schedule, duration, 
disruption frequency (4-point Likert scale), and quality (4-point Likert scale). Scores range from 0-21, 
with higher scores indicating worse sleep quality. The PSQI has demonstrated validity in cancer patients 
with Cronbach’s alpha ranging from 0.77-0.81.40 Estimates for the MCID for the PSQI index score range 
from 1.3 to 4.4.41  
 
Potential Moderator and Exploratory Outcomes  
As no suitable tool was available when the RCT commenced, a simple 28-item immersion survey 
instrument was developed based upon prior work exploring immersive fidelity (quality of audio-visual 
representation on sense of immersion in the environment) and presence (sense of dislocation from the 
real world and being present in a virtual world).42,43 Items used 5-point Likert scales, with two global 
items assessing immersion and presence on 10-point Likert scales. This survey incorporated the 
previously validated Immersion Experience Questionnaire (IEQ)44 and was administered at the end of 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
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each week of the trial. Potential moderator demographic variables were also collected including age, 
gender and type of cancer. Any reported cybersickness (VR-induced motion sickness) was recorded by 
participants weekly on a 5-point Likert scale, with an option to add comments.45,46,47   
  
Participant timeline  
During the trial, each participant engaged in a daily 30-minute immersive media therapy session in their 
own homes, either as a VR activity or a screen-based laptop activity for the control group. The NPI was 
used every day for a month, using one of four different applications for a week each starting on a 
Monday, for six days in sequence. There was a one-day rest/washout period on Sunday at the end of the 
week before changeover to the next application (Figure 1).   
 
Equipment was initially set up in the participant’s own home at the start of the month, and orientation 
and training provided involving a detailed overview of the study, instruction and provision of a data 
collection binder with daily and weekly measures, as well as familiarization with equipment and 
applications. The binder was sectioned into each week, with daily sheets including instructions to record 
the time spent each day, and their pre, during, and post exposure VAS pain scores. To avoid the effects 
of interrupting the immersive activity, participants were asked to complete the “during” VAS pain score 
immediately after the session by “thinking back to somewhere in the middle of your session and fidelity 
your pain at that time.” Participants were supplied a timer they were asked to set for 30-minutes; 
however, they were told this was a minimum and that if they wanted to spend more time to complete 
their puzzle or task, they were welcome to. At the end of each week, participants completed the SF-12, 
PSI, SF-MPQ, and the Immersion/Presence survey, including cybersickness fidelity and any deviations 
from the binder. The end-of-study questionnaire included the option to add comments on how useful 
they found the NPI overall and any other thoughts they wished to record about the therapy.  
 
 
 
 
 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
9 
 
Figure 1: Study Participant Timeline.  
Notes: A,B,C,D are the matched VR/Non-VR Activities undertaken, i.e., OB, VMW, WF    
 
 
Sample size  

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
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Sample size was determined by a power analysis to test group differences in pain intensity between two 
arms. Due to limited recruitment feasibility, a third no intervention arm was impractical, and the two 
arms were considered sufficient to establish the impact of VR as a discrete pain therapy. As reliable 
estimates of expected effect size were unknown, the study was powered to detect a medium effect (0.5 
SD change), considered a reasonable clinically meaningful impact to obtain 80% power based on a 
repeated measures analysis of variance (RM ANOVA) with 2-tailed alpha of .05 model. 48 Power 
calculated using the G*Power application suggested a minimum sample size of 100 participants (50 in 
each group).   
 
Recruitment 
Community-dwelling adults with cancer-related chronic pain were recruited through postings in cancer 
clinics, pain clinics, hospitals, support groups, support networks (PainBC, People in Pain Network), 
physician networks, social media, and the REACH BC research volunteer website. Initial recruitment 
focused on BC. Recruitment was expanded to Alberta in 2020 and Canada-wide in 2022. 
 
Assignment Of Interventions: Allocation 
Sequence generation  
Applicants were screened for eligibility and assigned a participant ID by the research coordinator. The 
research assistant responsible for equipment setup would then determine the participant’s group from 
the assignment sheet. Participants were randomly assigned to either the VR or control group in blocks of 
12 using a Latin Square design assignment sheet prepared by a professional statistician. Each block of 12 
included six unique permutations for order of the NPI applications used to effectively randomize 
allocation and avoid sequencing effects.  
  
Concealment mechanism  
Arm allocaƟon (VR or control) was concealed to applicants, who were informed they were taking part in 
a multimedia pain-relief study, not a VR study. 
 
Implementation 
Arm allocaƟon and NPI allocaƟon sequence was undertaken by the research assistants. 
 
Assignment Of Interventions: Blinding 
Who were blinded  
ParƟcipants only were blinded to allocaƟon and sequence (single binding) as it was not possible to 
conceal treatment allocaƟon by the research team. 
Procedure for unblinding if needed  
None, as no pharmacological, invasive or potentially harmful intervenƟons were used. 
 
Data Collection and Management 
Plans for assessment and collection of outcomes  
Participants used a written data collection binder with daily and weekly measures, as well as 
familiarization with equipment and applications. The binder was sectioned into each week, with daily 
sheets including instructions. 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
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Each day participants recorded their pre, during, and post exposure VAS pain scores, and the time spent 
using the NPI. To avoid the effects of interrupting the immersive activity, participants were asked to 
complete the “during” VAS pain score immediately after the session by “thinking back to somewhere in 
the middle of your session and fidelity your pain at that time.”  
At the end of each week, participants completed the SF-12, PSI, SF-MPQ, and the Immersion/Presence 
survey, including cybersickness fidelity and any deviations from the binder. The end-of-study 
questionnaire included the option to add comments on how useful they found the NPI overall and any 
other thoughts they wished to record about the therapy.  
 
Plans to promote participant retention and complete follow-up  
ParƟcipants who withdrew from the study, were asked to provide a reason for withdrawal (this was not 
compulsory). Data from parƟally completed parƟcipants was included whenever possible when suﬃcient 
for quanƟtaƟve staƟsƟcal analysis  
 
Data management  
A current list of the names of study personnel (including coinvestigators and research staff) and their 
delegated tasks was maintained in the study file. Personal data was be kept solely on a UBC networked 
encrypted computer data storage. Drs. Garrett, Gromala and Taverner had access throughout the study 
(and the PI and CI to the archive thereafter). The Project Manager and research assistants had access to 
the data during the course of their employment on the project with UBC.  
 
Confidentiality 
Only the consent forms had the participants identification, and the electronic password protected key 
data file with names and subject numbers. Thereafter participants were referred to by Research subject 
identifiers (numbers) only not derived from any existing personal identifiers (e.g., SIN). The consent 
forms were kept in a locked cabinet in the principal investigator's locked office. All participants were 
issued with a study number identification, this number were used on all data collection files and data 
spreadsheets, analysis and reporting. A password protected file with contact details and addresses were 
kept on an electronic file, this were password protected and kept on a computer at UBC. 
Only the researchers identified on this ethics approval will have access to the data. All physical 
documents and files pertaining to this study were identified only by code number and kept in a locked 
filing cabinet in a locked office in the UBC School of Nursing. Apart from the password protected single 
key data file, all data stored on electronic media (computers) at UBC’s School of Nursing did not include 
the name or personal details of the individual subject. 
 
Statistical Methods 
Statistical methods for primary and secondary outcomes  
A first exploration of all outcomes across all participants was undertaken, using an intention to treat 
analysis (where all participants were included in the statistical analysis and analyzed according to the 
group they were assigned, regardless of individual changes in protocol). For the primary outcomes of 
interest, a minimum clinically important difference (MCID) of 10mm on the VAS scale was adopted. The 
data exploration also found highly varied pain experiences by many participants throughout the trial, 
with many beginning their daily activity with pain below a 40mm VAS score, or even with no pain on 
some days. Hence, a further sub-group analysis was undertaken excluding data from participants whose 
pre-exposure VAS score was less than 40mm on that day, to explore for effects in this sub-group of 
participants who were experiencing more substantial pain at the time of the NPI exposure.   

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
12 
Linear mixed effects modelling was used to establish whether there were differences in the outcomes of 
interest between the VR and control groups. Patient-level random effects were considered to account 
for the repeated outcomes measures. Interaction terms of participant exposure and time were included 
in each model and used to ascertain whether changes in the outcomes of interest from baseline - before 
each activity for the daily and before exposure to NPI for the weekly outcomes and at specific time 
points – during and after each activity for the daily and at day six for the weekly outcome measures – 
were different between the VR and non-VR groups. Baseline demographic characteristics and duration 
of exposure to each environment for the daily outcomes were considered for adjustment in the full 
models. Terms were sequentially removed from the full models if their exclusion did not affect model 
fit. Reduced models were compared to full models using the Akaike Information Criteria (AIC) and those 
with the lower values were identified as the final models for each outcome. Using the final models, 
adjusted values of each outcome per group were estimated and presented as mean summaries with 
standard errors as a measure of dispersion. The 95% confidence interval (CI) of the fixed effects were 
estimated using the bootstrapping method and graphical plots of residuals and fitted values were used 
to determine whether normality and constant variance assumptions were met. To explore potential 
correlations between video and audio fidelity, and cyber sickness between applications in the immersion 
survey a two-sample t-test was also used. All analyses were conducted using R statistical software. For 
more details on the statistical analysis plan, please refer to Appendix A.  
 
Interim analyses  
An interim analysis was completed in 2021 (n=52) and indicated no substantive difference between 
arms, and no significant adverse events. The study was continued to achieve the intended sample size. 
 
Methods for additional analyses (e.g., subgroup analyses)  
For the primary outcomes of interest, a minimum clinically important difference (MCID) of 10mm on the 
VAS scale was adopted. The initial data exploration also found highly varied pain experiences by many 
participants throughout the trial, with many beginning their daily activity with pain below a 40mm VAS 
score, or even with no pain on some days. Hence, a further sub-group analysis was undertaken (using 
the same methods outlined above) excluding data from participants whose pre-exposure VAS score was 
less than 40mm on that day, to explore for effects in this sub-group of participants who were 
experiencing more substantial pain at the time of the NPI exposure.   
 
Methods in analysis to handle protocol non-adherence and any statistical methods 
to handle missing data  
A complete case analysis was conducted as there were few participants (<5%) with missing data.  
 
Plans to give access to the full protocol, participant level-data and statistical code 
This protocol is publicly available from the clinicaltrials.gov website, or from the primary researcher on 
request. 
 
Oversight and Monitoring 
Composition of the coordinating centre and trial steering committee  
Primary Investigator and Project leader: Dr. Bernie Garrett: responsible for overall project leadership, 
management, and staffing. 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
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13 
Co-Investigators: Dr. Tarnia Taverner and Dr. Diane Gromala: oversaw project management with bi-
weekly review meetings, and  assisted in data analysis, and report writing. 
Project Coordinator: Crystal Sun (oversaw day to day project management, coordinated b-weekly 
meetings, managed financial accounts and report writing) 
Research Assistants: Gordon Tao (PhD Candidate), Elliot Cordingly: (undertook VR installation set up, 
take-down collected data binders, provided participant support and assisted in data cleaning and 
collation for analysis, and report writing. 
StaƟsƟcian: Richard Musoke (PhD Candidate): Undertook statistical analysis, data cleaning and collation 
for analysis, and report writing. 
 
Composition of the data monitoring committee, its role and reporting structure  
As a small scale trial (with no more than 6 participants participating at any one time) a secondary DMC 
was not required. 
 
Adverse event reporting and harms  
A weekly form for reporƟng adverse events was required to be completed by all parƟcipants. In addiƟon, 
parƟcipants were biased to report any substanƟve negaƟve experiences or adverse events by telephone 
to the provided research helpline immediately. 
 
Frequency and plans for auditing trial conduct  
The independent UBC Behavioural Research Ethics Board was able to audit the study at any Ɵme to 
ensure pracƟces were carried out in accordance with the ethical approval cerƟﬁcate. No audit was 
carried out during the course of the study. 
 
Plans for communicating important protocol amendments to relevant parties (e.g., 
trial participants, ethical committees)  
All changes to eligibility, recruitment methods, procedures, outcomes, analyses were reported to the 
UBC BREB for review and approval as post-approval activities, and all changes amended on the 
clinicaltrials.gov site. 
 
Dissemination plans 
This study supports a knowledge translaƟon (KT) process designed to develop theory based on 
pre-exisƟng innovaƟon, and further deﬁne the pracƟcal determinants, implementaƟon and 
uptake consideraƟons for VR use in wider pracƟce. The primary KT target audiences will be 
healthcare professional groups involved in the management of chronic pain, paƟents experiencing 
chronic pain, and their relaƟves, although we will be careful to avoid prematurely claiming our 
study ﬁndings as generalizable. Health Professional academic/clinical conference presentaƟons 
will also be undertaken, and it is planned at least three peer-reviewed publicaƟons in professional 
journals will be produced. In addiƟon, a publicly accessible project summary will be sent to all 
parƟcipants and a project website with video and text based resources related to the work has 
been established at htps://blogs.ubc.ca/arvrha/ where the ﬁnal report will be posted, with links 
to the publicaƟons arising from it. 
 
 
  

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
14 
Discussion 
Due to the global COVID-19 pandemic, the study was paused completely between March 2020 to June 
2020. The study was paused two more times (November 2020 - July 2021; Dec 2022) due to pandemic 
conditions. From June 2020, the study restarted with modified protocols to minimize physical contact 
and ensure safety according to Behavioural Research Ethics Board guidelines. Participants were 
screened for COVID-19 exposure and symptoms before each contact. Baseline demographic and 
outcomes data collection was moved from the set-up session to a teleconference interview session to 
shorten the session. Participants also received online videos for equipment training to review before the 
study visit. The set-up session was modified to require personal protective equipment and 2-metre 
distancing between RA and participant, relying on verbal instructions and demonstrations observed at a 
distance for training. Weekly check-ins also included screening for COVID-19 symptoms and 
reassessment of consent. At the end of the participant’s 4 weeks, equipment was disinfected during 
collection then stored in a secure room for 4 days before preparation for use by another participant.  
When we expanded recruitment across Canada in 2022, we modified the set-up protocol to be 
completely remote. For participants located outside of BC, participants were shipped all study 
equipment. For VR, participants received a high-end gaming laptop that could run all VR environments 
at the highest graphical settings instead of a desktop computer. Participants were asked to view a brief 
tutorial video on how to set up the equipment. Once the participants received the equipment, an RA 
would conduct the set-up session via teleconference. 
 
Declarations 
 
Acknowledgements 
We acknowledge Dr. Diane Gromala, Dr. Christopher Shaw, and their graduate students at the Pain 
Studies Lab at Simon Fraser University for the development of Virtual Meditative Walk, one of the 
environments used in the study, and their continued support and collaboration throughout the project. 
We also acknowledge the support of Dr. Bechara Saab, at Mobio Interactive for the development and 
use of Qualia Wildflowers (WF), Cyan Worlds for Obduction (OB), and Hammer Labs for Carpe Lucem 
(CL) by supporting free use of their VR applications in the study. We thank Dr. Pippa Hawley and Dr. Gil 
Kimel for their support with participant recruitment at BC Cancer centres and at St John Hospice. We 
also thank the Lotte and John Hecht Memorial Foundation for their funding to conduct this research 
(Grant ID: 4110). The funding source has no authority in the study design or execution or in this 
manuscript's preparation. Lastly, we want to thank all the participants in this research study for their 
time and effort, without whose participation this work would not have been possible.  
 
Authors’ contributions  
Dr. Bernie Garret. Professor, University of BriƟsh Columbia, School of Nursing, Vancouver, BC, Canada 
Dr. Tarnia Taverner, Adjunct Professor, University of BriƟsh Columbia, School of Nursing. Vancouver, BC, 
Canada  
Dr. Diane Gromala, Professor, Simon Fraser University, Pain Studies Lab, School of InteracƟve Arts and 
Technology, Surrey, BC, Canada.  
Project Coordinator: Crystal Sun 
Research Assistant: Gordon Tao (PhD Candidate). 
 
All the above authors contributed to the creation of this document. 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
15 
 
Funding  
The funding for this work was provided by the Lotte and John Hecht Memorial Foundation for their 
funding to conduct this research (Grant ID: 4110).  
The following companies supplied their products for free for use in this study:  Mobio Interactive 
supplied Qualia Wildflowers (WF), Cyan Worlds supplied Obduction (OB), and Hammer Labs supplied 
Carpe Lucem (CL). 
 
Availability of Data and Materials 
Public access to the ﬁnal trial dataset, which is available for free academic use is authorized by the 
researchers. These data are available from clinicaltrials.gov, the open access publications arising from 
this work, and from the authors by request. Previous open access publications related to this work 
include the following: 
 
Garrett B.M., Taverner, T., Tao G., Cordingley E., Sun C. (2020) Patients Perceptions of Virtual Reality 
Therapy in the Management of Chronic Cancer Pain. Heliyon. 6(5) doi: 
https://doi.org/10.1016/j.heliyon.2020.e03916  
 
Tao, G., Garrett, B.M., Taverner, T., Cordingley, E., & Sun, C. (2020). Immersive virtual reality health 
games: a narrative review of game design. In Journal of NeuroEngineering and Rehabilitation (Vol. 18, 
Issue 1, p. 31). BioMed Central Ltd. doi: https://doi.org/10.1186/s12984-020-00801-3 
 
Fu, H., Garrett, B., Tao, G., Cordingley, E., Ofoghi, Z., Taverner, T., Sun, C., & Cheung, T. (2022). Virtual 
Reality Guided Meditation for Chronic Pain in Cancer Patients: An Exploratory Analysis of EEG Activity. 
JMIR Biomedical Engineering, 6(2), e26332. https://doi.org/10.2196/26332 
 
Ethics approval and consent to participate  
Ethical approval for the study was granted by the UBC, behavioural research, ethics, board, (cerƟﬁcate 
number H16-01510). Writen, informed consent to parƟcipate were obtained from all parƟcipants prior 
to participation and data collection. 
 
Consent for publication 
The authors listed above consent to the use of the publicizaƟon and use of this protocol for academic 
use. A model consent form is also available. 
 
Competing interests 
The authors listed above declare that they have no compeƟng interests. 
 
Authors’ information 
Dr. Bernie Garrett, is a professor at the University of British Columbia School of Nursing and comes from 
an acute care and Nephrology Clinical Nurse Specialist background. He has a PhD in Information Science 
from the University of Portsmouth in the UK, a PGCEA from the University of Cardiff, UK and is an RN 
with numerous clinical certifications. His work focuses on science and technology. His research  falls into 
two areas. Firstly, the use of new immersive media technologies in healthcare applications (such as 
Virtual reality), and secondly deception in healthcare products and services (including alternative 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
16 
medicine). He is an author of a numerous research papers, science-based clinical textbooks, and a 
popular science text. https://nursing.ubc.ca/our-people/bernie-garrett  
 
Dr. Tarnia Taverner is an adjunct professor the University of British Columbia School of Nursing, and a 
clinical pain specialist. She holds a Ph.D Doctorate from The University of Leeds, Faculty of Healthcare 
and a Masters in Science MSc. from the University of Leicester, Faculty of medicine and is an RN. Dr. 
Taverner has experience with diverse health care delivery, directing and leading healthcare at local, 
provincial and National and International levels. Has a strong background in clinical, scientific and 
academic expertise. Has obtained an excellent track record in healthcare leadership most recently with 
PHSA as Senior Director at BC Children's Hospital, a provincial center of excellence hospital for sick 
children. She is a published author with over 20 publications in scientific peer reviewed journals. 
https://www.researchgate.net/profile/Tarnia-Taverner  
Dr Diane Gromala is a DisƟnguished Simon Fraser University (SFU) Professor in the School of InteracƟve 
Arts and Technology (SIAT). She builds bridges spanning technology (design, human computer interface, 
and engineering) and health (researchers, clinicians, paƟents and their advocates). Prior to joining SFU, 
Dr. Gromala developed transdisciplinary technology curricula as a faculty member at Georgia Tech, the 
University of Washington, and the University of Texas. She holds a PhD, in Computer Science, Human 
Computer InteracƟon, from the University of Plymouth, UK, an MFA, Graduate Studies in Design, from 
Yale University (1990), and a BFA, Design & Photography, from the University of Michigan (1982). Dr. 
Gromala designs and builds innovaƟve interacƟve health technologies, and tests them in a two-pronged 
approach: with health experts in clinical domains, and in paƟents’ homes. She is author of over 100 
research papers . htps://www.sfu.ca/siat/people/research-faculty/diane-gromala.html  
 
 
 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
17 
Appendix A – Detailed Statistical Analysis Plan  
 
1. Objective 
Determine the extent to which VR-based applications are advantageous for daily home-based 
chronic cancer pain management, compared to equivalent applications experienced on two-
dimensional (2D) computer screens. 
 
2. Outcomes 
This section presents the outcomes investigated to answer the study objective. The analyses are 
described in section 3. 
 
Primary outcomes 
Visual analogue scale pain scores from 0 to 100mm measured before, during and after an 
immersion for 24 days. 
 
Weekly pain scores measured using the McGill Pain Questionnaire separately for each 
component sensory pain (11 items), affective pain (4 items), Visual Analogue Scale component 
scored out of 10 and overall, as a sum for all three components measured at baseline and at week 
1, 2, 3 and 4. 
 
Secondary outcomes 
Health related quality of life scores measured using physical and mental health components of 
the short form quality of life questionnaire and the sleep quality index measured using the 
Pittsburgh Sleep Quality Index all measured at baseline and at week 1, 2, 3 and 4. 
 
3. Population and Subgroup Analyses  
 
Populations 
Intention-to-treat (ITT) 
All randomized participants will be included in the analysis as allocated to either the intervention 
or control arm.  
 
Sensitivity analysis  
A subgroup analysis of participants with pain scores before an immersion session will be 
conducted. Analyses for this population will be used to investigate whether conclusions are 
sensitive to severity of pain before an immersion session.  
 
Subgroup analyses 
Four sub-analyses will be conducted for each application. All sub-analyses groups will be 
conducted for the overall sample and for the sample with severe pain. 
 
4. Data analyses 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
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All outcomes will be presented using descriptive statistics; normally distributed data by the mean 
and standard deviation (SD) or standard errors (SE) and binary and categorical variables will be 
presented using counts and percentages. R software version 2.4.3 will be used for all statistical 
analysis. 
 
The sections below describe analyses that will be conducted in addition to the descriptive 
statistics. 
 
Primary outcome  
The primary analysis will compare mean changes in daily pain before each immersion session and 
pain scores during and after each session in intervention group to mean changes in daily pain 
before each immersion session and pain scores during and after each session in control group. 
Difference in pain score before to time points where it is measured during and after each session 
(during and after) will be the dependent variable. Study participants will be considered as random 
effects, treatment group and time together with an interaction term of the treatment group and 
time as fixed effects. The estimated difference in mean change from before to during, and after 
immersion sessions and the corresponding 95 % confidence interval (CI) between groups will be 
presented. 
 
Using a similar approach, the mean changes in weekly pain from baseline measured using the 
McGill Pain Questionnaire for the overall pain score – combining assessing sensory pain (11 
items) and affective pain (4 items) as well as a VAS component scored out of 10, and separately 
for each component – in intervention group to mean changes in weekly pain in control group will 
be compared. 
 
Secondary outcomes 
Mean changes from baseline in weekly health related quality of life scores and sleep quality index 
measured using the Health Survey Short Form quality of life and Pittsburgh Sleep Quality Index 
respectively were compared between the intervention and control groups using the approach 
like that of weekly primary outcomes.  
  
5. Missing data 
When analyzing data for all study participants and those with severe pain, complete case analyses 
will be conducted for both primary and secondary outcomes. If the number of participants 
excluded due to missing demographic characteristics is >5% comparisons by assignment arm of 
those included and those excluded will be conducted to determine if there are any differences in 
drop out by arm. 
 
 

UBC School of Nursing. Immersive MulƟmedia as an AdjuncƟve Measure for Pain Control in 
Cancer PaƟents Research Protocol 1.0  
19 
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