Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02995434|
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : October 29, 2020
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.
At the end of the study, 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 magnetic resonance imaging (MRI) studies.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Cancer||Device: Virtual Reality Headset Other: 2D PC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients|
|Actual Study Start Date :||July 31, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Intervention Group
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.
Device: Virtual Reality Headset
The following VR experiences will be used:
Virtual Meditative Walk:http://painstudieslab.com/projects/virtual-meditative-walk/ Qualia: Zen Eagle:http://www.mobiointeractive.com/big-picture/index.html Obduction: http://obduction.com/ Carpe Lucem: http://store.steampowered.com/app/433700/Carpe_Lucem__Seize_The_Light_VR/
Other Name: HTC Vive
Active Comparator: Control Group
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.
Other: 2D PC
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/ Qualia: Zen Eagle:http://www.mobiointeractive.com/big-picture/index.html Obduction: http://obduction.com/ The Witness: http://store.steampowered.com/app/210970/
- Change in Visual Analog Score for Pain [ Time Frame: 1min before VR session, 10mins into VR session, 20mins into VR session, 30mins into VR session, 40mins into VR session, 50mins into VR session and 1 min after VR session ]Use of the visual analog score for pain which is programmed into the VR gaming experience. Subjects will be asked about their pain intensity 1min prior to the start of the VR session and at 10mins intervals during the VR session, and 1min after the VR session. The visual analog scale will be programmed into the select VR environments for ease of selection by subjects.
- Neuronal Activity [ Time Frame: Before and after 30mins of VR session ]Observe change in neuronal activity in the brain before and after a 30min VR session using fMRI
- 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 ]Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks
- Experience of using VR [ Time Frame: One month after VR session ]A questionnaire as well as a focus group interview will be conducted one month after participants' VR session. Questions will focus on their experience of using VR (i.e., positives for using VR, negatives for using VR, would they use this therapy or not in the future etc.)
- Impact of VR on Pain [ Time Frame: One month after VR session ]A questionnaire as well as a focus group interview will be conducted one month after participants' VR session. Questions will focus on the impact of VR on their pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995434
|Contact: Crystal Sun, MPH||6048227679||Crystal.Sun@ubc.ca|
|Contact: Bernard M Garrett, Ph.D.||6048227679||Bernie.Garett@ubc.ca|
|Canada, British Columbia|
|Simon Fraser University - School of Interactive Arts and Technology||Recruiting|
|Surrey, British Columbia, Canada, V3T 0A3|
|Contact: Diane Gromala, Ph.D. email@example.com|
|Sub-Investigator: Diane Gromala, Ph.D.|
|University of British Columbia - School of Nursing||Recruiting|
|Vancouver, British Columbia, Canada, V6T 2B5|
|Contact: Bernard Garrett, Ph.D. Bernie.Garrett@ubc.ca|
|Principal Investigator: Bernard M Garett, Ph.D.|
|Vancouver, British Columbia, Canada|
|Contact: Phillipa Hawley|
|Principal Investigator:||Bernard M Garrett, Ph.D.||University of British Columbia - School of Nursing|