AzTrials
AzTrials

Chronic PainNCT02995434

Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients

A study testing Virtual Reality Headset and 2D PC in people with Chronic Pain and Cancer, run by University of British Columbia at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study seeks to explore the efficacy of immersive multimedia experiences as a practical adjunctive therapeutic intervention in the self-management of the chronic pain associated with cancer patients. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Pain, Cancer
What is being tested?
Virtual Reality Headset and 2D PC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
3 sitesCanada
Study dates
31 Jul 2017to 31 Dec 2022
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Age 16 or older
  • Previous or current medical diagnosis of cancer
  • Previous or current treatment by chemotherapy, radiotherapy, hormonal
  • Currently an outpatient (not hospitalized)
  • Chronic pain sufferer (suffering ongoing daily pain for 3 months or more with a Neuropathic Rating Pain Scale score of 4 or more)
  • Able to understand the English language, and read and write English
Show all 10Show fewer
  • Have normal stereoscopic (binocular) vision
  • Able to easily move your head up, down, left and right and wear a headset
  • Have fine motor control in one hand sufficient to operate a joystick/control
  • Have space at home for a computer and monitor equipment

Who cannot join

  • Cognitive impairment/inability to control a basic computer VR interface, or complete questionnaires
  • Receiving regular non-pharmacological pain relieving adjunct therapies for the management of chronic pain
  • Susceptibility to motion sickness/cyber-sickness
  • Susceptibility to claustrophobia (fear of confined places)
  • History of susceptibility to seizures

Trial locations and contacts

3 sites in 1 country.

Canada3 sites
  • Simon Fraser University - School of Interactive Arts and Technology

    Surrey, British Columbia, V3T 0A3

  • University of British Columbia - School of Nursing

    Vancouver, British Columbia, V6T 2B5

  • BC Cancer

    Vancouver, British Columbia

Other trials in Canada

About this study

This study seeks to explore the efficacy of immersive multimedia experiences as a practical adjunctive therapeutic intervention in the self-management of the chronic pain associated with cancer patients. A comparative controlled interventional trial and qualitative interpretative-descriptive exploration will be undertaken with 100 cancer patients who are experiencing chronic pain. Participants will be randomly assigned to either a virtual reality (VR) therapy group or a 2D computer based multimedia control group (50 subjects in each).

They will undertake either a series of VR interventions, or 2D computer based multimedia control sessions in their own homes over a period of a month. The intervention will be used daily for a month to enable customization to the therapy and record data over a long enough period of time to account for any individual short-term changes in pain.

Read more

The VR sessions will consist of using a VR head mounted display (HMD) and computer to explore interactive immersive environments. The control group will be exposed to similar 2D computer based multimedia experiences (without a VR headset) that on home computers. Pre, during, and post pain test scores and quality of sleep assessments will be recorded using standardized tools.

In addition to the primary study, a sub-study will be conducted where ten of the subjects who demonstrated the most improvement in their pain using the VR experience will be selected and invited to explore for any measurable changes in neurological activity using pre and post exposure electroencephalography (EEG).

Read the detailed description

This study seeks to explore the efficacy of an immersive multimedia experience as a practical therapeutic intervention in the self-management of the chronic pain associated with cancer patients.

This work will inform further clinical studies and future research into the potential uses of immersive multimedia in the treatment of cancer associated pain. Furthermore, it will help identify optimal immersive multimedia environments for use in chronic pain applications, practical determinants for implementation of immersive multimedia for wider practice, and will provide a better theoretical understanding of the mechanisms whereby immersive multimedia works in chronic pain.

JUSTIFICATION

Cancer survivorship refers to individuals who have remained cancer free for a minimum of 5 years. 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. 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.

With rapidly emerging immersive multimedia technologies and clinical work in this field, it would appear that immersive multimedia may have significant potential for use as an adjunctive therapeutic measure for pain control. However, there has been little work done to establish the potential use of immersive multimedia in the management of chronic cancer pain to date, as most work on immersive multimedia for pain management has focused on acute pain via distraction. Several researchers have recommended the investigation of immersive multimedia for chronic, long term pain, and the research team completed a pilot study in 2015 to establish best methods and approaches for using immersive multimedia in chronic pain conditions.

OBJECTIVES

To determine if immersive multimedia therapy is effective as an adjunctive intervention in the management of chronic pain in cancer patients?

  1. Can exposure to a immersive multimedia environment as an adjunctive pain-relieving measure provide a pain-reducing experience for for chronic cancer pain patients?
  2. How long (if at all) do any therapeutic effects of immersive multimedia last after exposure in chronic cancer pain patients?
  3. Are there any significant side effects of immersive multimedia exposure for chronic cancer pain patients?
  4. Do any identifiable neurological changes occur on EEG pre and post immersive multimedia exposure?

RESEARCH METHODS

A longitudinal mixed-methods study to evaluate the impact of immersive multimedia for chronic pain in cancer patients is proposed which will consist of a comparative controlled interventional trial and qualitative interpretative-descriptive exploration.

  1. Interventional Trial (Quantitative): Participants will be randomly assigned to either a VR therapy group or the control group (50 subjects in each). They will undertake either a series of immersive VR interventions, or control sessions (using 2D multimedia on personal computers) in their own homes over a period of a month. To ensure the multi-dimensional aspects of chronic pain experienced by individuals are measured adequately, pain assessment tools have been selected that will address different aspects of each participant's' chronic pain and functional capacity. To measure the impact of VR on each participant's pain intensity, the Visual Analog Scale will be used during the VR and control experiences, pre and post exposure and at 10 minute intervals. In order to measure the change in pain during the therapy experience, and overall sleep quality, at the end of each week, participants will also be asked to complete post-intervention questionnaires: Health Survey (Short-Form 12), McGill Pain Questionnaire, the Pittsburgh Sleep Quality Index, and also a brief Virtual Reality Immersion Tool (to assess how immersive they found the experience that week).
  2. Interpretive Description Study (Qualitative):

A Qualitative Interpretative-Descriptive exploration will be undertaken alongside the trial to allow for a more open exploration of participants experiences and to further understanding of the perceptions associated with the use of immersive multimedia and any impact upon their chronic pain. An interpretative description (ID) approach will be used for this aspect of the study. This methodology allows for an inductive descriptive analysis of the phenomena, and was chosen as it is ideal for small scale studies, allowing for generation of themes, patterns and theory associated with the patient's experience.

Following the completion of the clinical trial all participants will be sent an exploratory questionnaire to discover their perceptions of immersive multimedia and its value (if any) in the control of their chronic pain. In this questionnaire they will also be invited to participate in one of two focus group interviews. Data from this will be analyzed and used to support purposeful sampling of individuals to take part in the following focus-group interviews, to include those subjects with a range of diverse opinions and ideas. As themes and categories emerge from the data the researchers will seek to adapt the focus-group interview sample with the purpose of strengthening the emerging theory and patterns by including individuals who will help further define the characteristics of these themes and categories.

Data Analysis

Quantitative Data: Descriptive and inferential statistical analysis will be performed on the pain scores. For face-value quantitative indicators of potential effects univariate descriptive statistics will be employed. Data will be analyzed for central tendency, dispersion (standard deviation, interquartile range), skewness and kurtosis using SPSS statistical analysis software to establish distribution and variance. Likewise, quantitative data from the questionnaires will be analysed in this fashion. Data will be explored for differences in the pain scales for the VR group and the control group at each time point to analyze for any indications of changes immediately following the experience using Linear Mixed Effects Modelling using SPSS software.

Qualitative Data: The focus-group interviews will be audiotaped. The questionnaire open text results and transcriptions of focus groups will be recorded into NVivo 11.0 qualitative data analysis software and read, re-read and coded for thematic elements by the PIs.

Conditions
Chronic Pain, Cancer
Being tested
Virtual Reality Headset, 2D PC
Keywords
Virtual Reality, Cancer Survivorship, Pain Management, Cancer Pain Management, Chronic Pain Management, Adjunctive Pain Management
Medical subject headings
Chronic Pain, Neoplasms, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality HeadsetDevice

    Also called HTC Vive

    The following VR experiences will be used:

    Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ Carpe Lucem: http://store.steampowered.com/app/433700/Carpe_Lucem__Seize_The_Light_VR/

  • 2D PCOther

    The control group will be exposed to 2D equivalent versions of the same multimedia experiences but on their PC screen (without the VR headset use). These will be functionally similar to the VR experiences. These will include:

    Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ The Witness: http://store.steampowered.com/app/210970/

Study groups in NCT02995434
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants will be randomly assigned to the intervention group (50 in total).The VR intervention will be identical for each participant and consist of a PC running the immersive virtual reality application with a Virtual Reality headset 110 degrees field of view head mounted display. The VR will be a set of commercial exploratory virtual environment games designed for the HTC Vive headset. The intervention will be used for one month to enable customization to the therapy and record data over a long enough period of time to account for individual short- term changes in pain experience. Participants will be asked to use the VR therapy every day with a time exposure of 30 minutes for four consecutive weeks. There will be one rest day a week (normally a Sunday) where no therapy is given.
Receives: Device: Virtual Reality Headset
Control GroupActive comparatorThe control group will be exposed to 2D PC equivalent versions of the same multimedia experiences but on their PC screen (without the Virtual Reality headset use). These will be functionally similar to the VR experiences.
Receives: Other: 2D PC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Visual Analog Scale (VAS)

    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). The clinically meaningful change for the VAS has been shown to be between 9mm and 12mm; for this study adopted the convention of 10mm as the minimum clinically important difference (MCID).

    Measured: Right before intervention (Pre), during intervention (During) and right after intervention (Post)

Secondary outcomes (4)
  1. McGill Pain Questionnaire

    The McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is a dimensional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain. The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain. Seven words are selected from the following categories: dimension 1 to 10 (pain descriptors), three words; dimensions 11 to 15 (affective components of pain), dimension 16 (evaluation of pain) one word, and dimension 17 to 20 (miscellaneous) one word. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain). Qualitative differences in pain may be reflected in respondent's word choice.

    Measured: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks

  2. Pittsburgh Sleep Quality Index

    the Pittsburgh Sleep Quality Index (PSQI) was used as a self-reported outcome measure assessing sleep quality at the end of each week. The measure includes 19 items asking about sleep schedule, duration, disruption frequency (4-point Likert scale), and quality (4-point Likert scale) using worse 0 to best 3. Scores are summed and range from 0-21, with higher scores indicating worse sleep quality.

    Measured: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks

  3. 12 Item Short Form Health Survey (SF-12) Physical Health Component Score

    The SF-12 is used to assess the impact of health on an individual's everyday life over the 4 weeks interval. It includes 12 items with binary response items (yes/no) and 3-6-point Likert items (worse to best). 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 the normative mean, respectively.

    Measured: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks

  4. 12 Item Short Form Health Survey (SF-12) Mental Health Component Score

    The SF-12 is used to assess the impact of health on an individual's everyday life over the 4 weeks interval. It includes 12 items with binary response items (yes/no) 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 the normative mean, respectively.

    Measured: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2016 (estimated)
  2. Study start31 Jul 2017
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02995434
Sponsor's protocol ID
H16-01510
Status last verified
Feb 2025
First submitted
12 Oct 2016
Last updated
14 Mar 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We can share the study protocol, statistical analysis plan, informed consent form as well as the analytic code used.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in