N/A
Completed N=110
Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients
Source: ClinicalTrials.gov NCT02995434 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Change in Visual Analog Scale (VAS) — -9.64; -7.56; -7.91; -8.43 units on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Analog Scale (VAS) |
-9.64; -7.56; -7.91; -8.43 | — |
| SECONDARY McGill Pain Questionnaire |
-0.90; -1.98; -2.02; -4.48; -3.36; -3.75 | — |
| SECONDARY Pittsburgh Sleep Quality Index |
-0.13; 0.50; -0.24; -0.86; -0.84; -0.71 | — |
| SECONDARY 12 Item Short Form Health Survey (SF-12) Physical Health Component Score |
2.03; -0.45; 1.38; -0.66; 3.40; -0.39 | — |
| SECONDARY 12 Item Short Form Health Survey (SF-12) Mental Health Component Score |
0.68; 2.99; 0.37; 4.27; 1.51; 2.38 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02995434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.