Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04572074
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2020-08-29
Brief Title:
Virtual Reality for Cancer Pain Management
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
Pilot Study to Evaluate Virtual Reality for Cancer Pain Management
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nauseavomiting 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 andor 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 11 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 httpw3uqocacyberpsydocsqairesimmersionITQ_vapdf
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 alpha005 and assuming a within-group standard deviation of 2 for each group Sample size calculations were conducted in PASS
After consenting to participate in addition to usual pharmacologic pain management 128 patients will be randomized with a 11 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 httpw3uqocacyberpsydocsqairesimmersionITQ_vapdf
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 alpha005 and assuming a within-group standard deviation of 2 for each group Sample size calculations were conducted in PASS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None