Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04572074 |
| Other study ID # |
2017-240 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2020 |
| Est. completion date |
September 30, 2022 |
Study information
| Verified date |
December 2022 |
| Source |
Medstar Health Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this research project is to evaluate the impact of virtual reality therapy on
mitigating cancer pain in hospitalized patients with cancer and compare this impact to that
of 2-dimensional guided imagery distraction therapy. The purpose is also to evaluate
acceptability of and satisfaction with virtual reality therapy and to examine racial and
cultural preferences related to virtual reality and guided imagery thematic content.
Description:
Subjects hospitalized at MedStar Washington Hospital Center will be considered for enrollment
in this study if able to provide consent, at least 18 years old, and report moderate-severe
pain (at least 4 out of 10 where pain is rated on a Likert scale between zero and 10) in the
previous 24 hours. Subjects will be excluded if they already use VR for personal use, have
intractable nausea/vomiting, history of motion sickness, history of seizures or epilepsy,
have cranial structure abnormalities that prevent use of VR headset, are currently enrolled
in a palliative care or pain management study, and/or are on contact isolation. Institutional
review board approval will be sought and informed consent will be conducted before enrolling
every patient.
After consenting to participate, in addition to usual pharmacologic pain management, 128
patients will be randomized with a 1:1 ratio to receive either one 10-minute VR session, or
one 10-minute 2-dimensional guided-imagery session. The investigators believe this sample
size is easily achievable given current palliative consult volumes for patients with cancer
at the study institution (see above); this sample size accounts for estimates that only
approximately half of eligible subjects are interested in trying VR therapies.
VR sessions will be administered using the Facebook (Facebook Inc., Menlo Park, CA) Oculus
Quest VR and Touch controllers. This equipment was selected because it is portable and can be
set up at the bedside in private or shared patient rooms. The hand controllers facilitate
immersive, interactive VR experiences for patients who may be bedbound or have limited
mobility in the inpatient setting. The VR software, Forest of Serenity (Holosphere VR ®,
Birmingham, UK) is a free application that features seven non-violent mini-games in a
carnival environment that can be played in a seated or fixed position.
The guided-imagery session depicts a peaceful walk through a forest with instrumental
background music and 2-dimensional imagery. Subjects will watch the guided imagery video on a
portable tablet for 10 minutes, the same duration as the VR intervention. Subjects in both
arms will continue to receive standard pharmacologic pain management. Because of the nature
of the compared interventions, subjects and researchers cannot be blinded to intervention.
The primary outcome measure will determine the impact of distraction therapy (either VR
therapy or 2-dimensional guided imagery) on self-reported pain experience. Self-reported pain
experience remains the standard for clinical pain research. Secondary outcomes will measure
impact of each distraction therapy on general distress level, general quality of life, and
satisfaction with pain management. For patients receiving opioid therapies for pain in the
preceding 24 hours, the investigators will also evaluate "as needed" opioid use.
Following consent and randomization, subjects will complete surveys on electronic tablets to
provide baseline data on pain scores, general distress, general quality of life, and
satisfaction with pain management. Pain will be assessed using the Brief Pain Inventory-Short
Form (BPI-SF, modified to assess symptoms in the last 24 hours) that includes a 0-10 Likert
scale for self-reported pain as well as information about pain location, quality, and
interference of pain on daily living. General distress will be measured using the Distress
Thermometer (a Likert scale measuring from No Distress to Extreme Distress, where "distress"
is defined by the patient). General quality of life will be measured using the Functional
Assessment in Chronic Illness-Therapy in Palliative Care 14-item (FACIT-Pal 14) scale that
measures non-pain symptoms and general well-being. Subjects will also be surveyed regarding
comfort with technology and self-directed use of passive and active distraction therapies.
After completion of baseline surveys, subjects will be administered either VR therapy for 10
minutes or 2-dimensional guided imagery for 10 minutes. For both arms, a member of the
research team will educate the subject on the technology and assure comfort with use,
remaining outside the room but nearby during the actual 10 minutes.
Following the distraction therapy, subjects will be re-surveyed BPI-SF, FACIT-Pal 14, and
Distress Thermometer. Both groups will also be surveyed and given semi-structured interviews
regarding acceptance of and satisfaction with the distraction therapy intervention itself and
its thematic content. Subjects randomized to VR therapy will be surveyed regarding level of
immersion of the VR experience (Immersive Tendencies Questionnaire,
http://w3.uqo.ca/cyberpsy/docs/qaires/immersion/ITQ_va.pdf).
In order to evaluate any residual effects of the distraction therapy, enrollees will be
re-surveyed BPI-SF, FACIT-Pal 14, Distress Thermometer, and pain management satisfaction
questions on the following day.
This study will reach 80% power to detect a difference of 1 unit in the pain score measure
between the 2 groups using a two-sample t-test with equal variance at a two-sided alpha=0.05
and assuming a within-group standard deviation of 2 for each group. Sample size calculations
were conducted in PASS.
