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

NCT02995434 | Completed Results

• 1 other identifier: H16-01510
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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. 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).

Conditions

Chronic Pain; Cancer

Keywords

Virtual Reality; Cancer Survivorship; Pain Management; Cancer Pain Management; Chronic Pain Management; Adjunctive Pain Management

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (4)

• McGill Pain Questionnaire

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

• Pittsburgh Sleep Quality Index

  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

  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

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

Study Arms (2)

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.

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.

Other: 2D PC

Interventions

Virtual Reality Headset DEVICE

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/

Also known as: HTC Vive

Intervention Group

2D PC OTHER

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/

Control Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Lotte & John Hecht Memorial Foundation: collaborator
• Simon Fraser University: collaborator
• Fraser Health: collaborator

Study Sites (3)

Simon Fraser University - School of Interactive Arts and Technology

Surrey, British Columbia, V3T 0A3, Canada

Location

University of British Columbia - School of Nursing

Vancouver, British Columbia, V6T 2B5, Canada

Location

BC Cancer

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Chronic Pain; Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Limitations and Caveats

There were several imitations in this study. First, the external validity may be limited as the types of cancer patients participating and pain types were heterogenous, and participant self-selection may mean they were not representative of the larger cancer chronic pain population. Secondly, the study may have been statistically underpowered due to the effect size selected, intervention exposure time, and multiple VR applications used as dependent variables.

Results Point of Contact

• Title: Dr. Bernie Garrett
• Organization: University of British Columbia

bernie.garrett@ubc.ca

604 822 7443

Study Officials

• Bernard M Garrett, Ph.D.

  University of British Columbia - School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: December 16, 2016
• Study Start: July 31, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Please reach out to us. Data will be available for a year after the study concludes.
• Access Criteria: Connect with researcher.

Locations

CA (3)