Virtual Reality for Cancer Pain Management
Primary Purpose
Cancer, Cancer Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided imagery
Virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- hospitalized, with primary diagnosis of cancer
- age 18 and older
- 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
Exclusion Criteria:
- already use VR for personal use
- intractable nausea/vomiting
- history of motion sickness
- history of seizures or epilepsy
- have cranial structure abnormalities that prevent use of VR headset
- currently enrolled in a palliative care or pain management study
- on contact isolation
Sites / Locations
- MedStar Washington Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1 (Guided imagery)
Arm 2 (Virtual reality)
Arm Description
10 minutes of guided imagery experience
10 minutes of virtual reality experience
Outcomes
Primary Outcome Measures
Change in self-reported pain score from baseline to immediately after assigned intervention
Likert scale 0 (no pain) to 10 (worst pain)
Secondary Outcome Measures
Change in self-reported distress from baseline to immediately after assigned intervention
National Comprehensive Cancer Network Distress Thermometer
Change in self-reported quality of life from baseline to immediately after assigned intervention
Functional Assessment in Chronic Illness-Therapy in Palliative Care 14-item scale (FACIT Pal 14 scale) -- subject replies to 14 questions about quality of life issues with responses in 5-point Likert scale (0 = not at all; 4 = very much), total score range 0-56
Acceptability of intervention ("Would you use this intervention again?") -- this single question designed for this study
Single best answer: subjects choose between two choices, "Yes" or "No"
Level of immersion experienced in virtual reality arm
Immersive Experience Questionnaire
Ease of intervention ("How easy was this technology for you to use?") -- this single question designed for this study
Single best answer to this question: subjects choose between "easy," "normal," or "difficult"
Change in self reported distress from baseline to Immediately after assigned intervention
National Comprehensive Cancer Network Distress Thermometer -- subject rates distress at that point in time on Likert scale 0-10 (0 = no distress; 10 = worst distress)
Full Information
NCT ID
NCT04572074
First Posted
August 29, 2020
Last Updated
December 2, 2022
Sponsor
Medstar Health Research Institute
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04572074
Brief Title
Virtual Reality for Cancer Pain Management
Official Title
Pilot Study to Evaluate Virtual Reality for Cancer Pain Management
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
September 29, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medstar Health Research Institute
Collaborators
American Cancer Society, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cancer Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 (Guided imagery)
Arm Type
Active Comparator
Arm Description
10 minutes of guided imagery experience
Arm Title
Arm 2 (Virtual reality)
Arm Type
Experimental
Arm Description
10 minutes of virtual reality experience
Intervention Type
Other
Intervention Name(s)
Guided imagery
Intervention Description
10 minutes of guided imagery experience
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
10 minutes of virtual reality experience
Primary Outcome Measure Information:
Title
Change in self-reported pain score from baseline to immediately after assigned intervention
Description
Likert scale 0 (no pain) to 10 (worst pain)
Time Frame
Baseline and again immediately after assigned intervention
Secondary Outcome Measure Information:
Title
Change in self-reported distress from baseline to immediately after assigned intervention
Description
National Comprehensive Cancer Network Distress Thermometer
Time Frame
Baseline and immediately after intervention, 24 hours after intervention
Title
Change in self-reported quality of life from baseline to immediately after assigned intervention
Description
Functional Assessment in Chronic Illness-Therapy in Palliative Care 14-item scale (FACIT Pal 14 scale) -- subject replies to 14 questions about quality of life issues with responses in 5-point Likert scale (0 = not at all; 4 = very much), total score range 0-56
Time Frame
Immediately after assigned intervention
Title
Acceptability of intervention ("Would you use this intervention again?") -- this single question designed for this study
Description
Single best answer: subjects choose between two choices, "Yes" or "No"
Time Frame
Immediately after intervention
Title
Level of immersion experienced in virtual reality arm
Description
Immersive Experience Questionnaire
Time Frame
Immediately after intervention (virtual reality arm only)
Title
Ease of intervention ("How easy was this technology for you to use?") -- this single question designed for this study
Description
Single best answer to this question: subjects choose between "easy," "normal," or "difficult"
Time Frame
Immediately after assigned intervention
Title
Change in self reported distress from baseline to Immediately after assigned intervention
Description
National Comprehensive Cancer Network Distress Thermometer -- subject rates distress at that point in time on Likert scale 0-10 (0 = no distress; 10 = worst distress)
Time Frame
Immediately after assigned intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hospitalized, with primary diagnosis of cancer
age 18 and older
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
Exclusion Criteria:
already use VR for personal use
intractable nausea/vomiting
history of motion sickness
history of seizures or epilepsy
have cranial structure abnormalities that prevent use of VR headset
currently enrolled in a palliative care or pain management study
on contact isolation
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Virtual Reality for Cancer Pain Management
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