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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 : April 26, 2019
Sponsor:
Collaborators:
Lotte & John Hecht Memorial Foundation
Simon Fraser University
Fraser Health
Information provided by (Responsible Party):
Bernard Garrett, University of British Columbia

Brief 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. 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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/





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


Other Outcome Measures:
  1. 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.)

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Crystal Sun, MPH 6048227679 Crystal.Sun@ubc.ca
Contact: Bernard M Garrett, Ph.D. 6048227679 Bernie.Garett@ubc.ca

Locations
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Canada, British Columbia
Simon Fraser University - School of Interactive Arts and Technology Recruiting
Surrey, British Columbia, Canada, V3T 0A3
Contact: Diane Gromala, Ph.D.       gromala@sfu.ca   
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.         
BC Cancer Recruiting
Vancouver, British Columbia, Canada
Contact: Phillipa Hawley         
Sponsors and Collaborators
University of British Columbia
Lotte & John Hecht Memorial Foundation
Simon Fraser University
Fraser Health
Investigators
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Principal Investigator: Bernard M Garrett, Ph.D. University of British Columbia - School of Nursing

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Responsible Party: Bernard Garrett, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02995434     History of Changes
Other Study ID Numbers: H16-01510
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bernard Garrett, University of British Columbia:
Virtual Reality
Cancer Survivorship
Pain Management
Cancer Pain Management
Chronic Pain Management
Adjunctive Pain Management

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms