Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02995434 |
| Other study ID # |
H16-01510 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 31, 2017 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
November 2022 |
| Source |
University of British Columbia |
| Contact |
Crystal Sun, MPH |
| Phone |
6048227679 |
| Email |
Crystal.Sun[@]ubc.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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).
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?
1. Can exposure to a immersive multimedia environment as an adjunctive pain-relieving
measure provide a pain-reducing experience for for chronic cancer pain patients?
2. How long (if at all) do any therapeutic effects of immersive multimedia last after
exposure in chronic cancer pain patients?
3. Are there any significant side effects of immersive multimedia exposure for chronic
cancer pain patients?
4. 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.
1. 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).
2. 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.
