Chronic Pain Clinical Trial
Official title:
Pilot Study to Evaluate Virtual Reality for Pain Management in Advanced Heart Failure
The purpose of this research project is to evaluate the impact of virtual reality therapy on mitigating heart failure pain in hospitalized patients with heart failure and compare this impact to that of 2-dimensional guided imagery distraction therapy.
Through ongoing collaborative work between the MedStar Heart and Vascular Institute Advanced
Heart Failure clinical team at our hospital and the MedStar Washington Hospital Center
Palliative Care team, the research team identifies hospitalized patients with a primary
diagnosis of heart failure (ACC/AHA stage C or D). Subjects 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 should be randomized with a 1:1 ratio to receive either one 10-minute VR session, or
one 10-minute 2-dimensional guided-imagery session.
VR sessions will be administered using the Facebook (Facebook Inc., Menlo Park, CA) Oculus GO
VR. The VR software that will be used is the Forest of Serenity (Holosphere VR®, Birmingham,
UK) application. The guided-imagery session depicts a peaceful walk through a forest with
instrumental background music and 2-dimensional imagery. Patients 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. Our 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.
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 NCCN
Distress Thermometer (a Likert scale measuring from No Distress to Extreme Distress, where
"distress" is defined by the patient; we will not include the tool's associated Problem List
due to overlap with other survey questions and attempt to avoid survey fatigue). 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.
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 patient 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 (Aim 1). Both groups will also be surveyed regarding acceptance of and
satisfaction with the distraction therapy intervention itself and its thematic content (Aim
2). Patients randomized to VR therapy will be surveyed regarding level of immersion of the VR
experience. 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.
Our 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.
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