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.
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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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?
- Can exposure to a immersive multimedia environment as an adjunctive pain-relieving measure provide a pain-reducing experience for for chronic cancer pain patients?
- How long (if at all) do any therapeutic effects of immersive multimedia last after exposure in chronic cancer pain patients?
- Are there any significant side effects of immersive multimedia exposure for chronic cancer pain patients?
- 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.
- 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).
- 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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants 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 Group | Active comparator | The 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.
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)
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
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
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
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.
- First posted16 Dec 2016 (estimated)
- Study start31 Jul 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation, Simon Fraser University, Fraser Health
- Responsible party
- Principal investigator, Bernie Garrett, University of British Columbia
- Investigators
- Bernard M Garrett, Ph.D., Principal investigator, University of British Columbia - School of Nursing
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients
- ClinicalTrials.gov ID
- NCT02995434
- Acronym / sponsor ID
- H16-01510
- Conditions
- Chronic Pain, Cancer
- Keywords
- Virtual Reality, Cancer Survivorship, Pain Management, Cancer Pain Management, Chronic Pain Management, Adjunctive Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Lotte & John Hecht Memorial Foundation, Simon Fraser University, Fraser Health
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
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?
- Can exposure to a immersive multimedia environment as an adjunctive pain-relieving measure provide a pain-reducing experience for for chronic cancer pain patients?
- How long (if at all) do any therapeutic effects of immersive multimedia last after exposure in chronic cancer pain patients?
- Are there any significant side effects of immersive multimedia exposure for chronic cancer pain patients?
- 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.
- 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).
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Virtual Reality HeadsetParticipants 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. |
| Control Group | Active comparator | Other: 2D PCThe 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality HeadsetAlso: HTC ViveThe 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/ | Device | Intervention Group |
| 2D PCThe 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/ | Other | Control Group |
Primary outcome
Change in Visual Analog Scale (VAS)
Time frame: Right before intervention (Pre), during intervention (During) and right after intervention (Post)
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).
4 secondary outcomes
McGill Pain Questionnaire
Time frame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
Pittsburgh Sleep Quality Index
Time frame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
12 Item Short Form Health Survey (SF-12) Physical Health Component Score
Time frame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
12 Item Short Form Health Survey (SF-12) Mental Health Component Score
Time frame: Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We can share the study protocol, statistical analysis plan, informed consent form as well as the analytic code used.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard M Garrett, Ph.D. principal investigator
University of British Columbia - School of Nursing
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) (time frame: Right before intervention (Pre), during intervention (During) and right after intervention (Post)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.