Status:
COMPLETED
Randomized Controlled Trial of Virtual Reality Assisted Guided Imagery (VRAGI) for Pain in Advanced Cancer Patients.
Lead Sponsor:
Prisma Health-Upstate
Collaborating Sponsors:
Clemson University
Conditions:
Cancer Pain
Oncology
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Introduction Patients with advanced cancer often experience high levels of debilitating pain and pain-related psychological distress. Although there is increasing evidence that non-pharmacological str...
Detailed Description
Objectives The primary aim of this pilot study is to measure the improvement in pain using virtual reality assisted guided imagery in participants with advanced cancer. The study will utilize a novel...
Eligibility Criteria
Inclusion
- \> 18 years of age
- Advanced cancer, defined as cancer that is incurable including locally advanced and metastatic cancers, with no plan for resection during the study period.
- Baseline pain score Edmonton Symptom Assessment Scale (ESAS) ≥ 4 (mean score during the screening week).
- Able to provide consent and willing to comply with all study procedures, as well as comprehend spoken and written English.
- Have access to a compatible Android, iOS smartphone, personal laptop, or desktop computer (excluding tablets) to complete surveys and respond to emails
Exclusion
- Have a condition that interferes with VR usage including history of seizure, facial injury precluding safe placement of an HMD, or other visual or hearing impairment that impacts ability to participate.
- Participated in a previous VR clinical study.
- Underwent a surgical procedure within 8 weeks.
- Have a neurocognitive disorder according to past medical history.
- Have brain metastases.
- Have a prognosis of \<3 months from the time of enrollment per treating oncologist.
- Experience current substance abuse.
- Experienced complex childhood trauma.
- Diagnosed with serious mental illness.
- \>65 years of age
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05348174
Start Date
June 1 2023
End Date
February 28 2025
Last Update
March 19 2025
Active Locations (3)
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1
Clemson University
Clemson, South Carolina, United States, 29634
2
Watermark Counseling
Columbia, South Carolina, United States, 29201
3
Prisma Health
Greenville, South Carolina, United States, 29605