Randomized Controlled Trial of Virtual Reality Assisted Guided Imagery (VRAGI) for Pain in Advanced Cancer Patients.
1 other identifier
interventional
41
1 country
3
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 strategies are needed to treat their pain, pharmacologic modalities remain the preferred strategy. Guided imagery is a form of focused relaxation that helps create harmony between the mind and body and has been shown to significantly improve cancer pain. This study presents Virtual Reality Assisted Guided Imagery (VRAGI) as an alternative pain treatment modality. The investigators of this study will conduct a randomized control trial to test its efficacy, feasibility, and safety in the home setting, for patients with advanced cancer. Methods and Analysis The study will recruit 80 participants from Prisma Health, a tertiary level health care center based in Greenville, South Carolina, USA using a stringent set of inclusion and exclusion criteria. The prospective 6-week, 2x2 randomized controlled trial will randomize participants to four groups: (1) VRAGI, (2) Laptop Assisted Guided Imagery (AGI), (3) VR (no guided imagery or other audio), and (4) laptop (no guided imagery or other audio). Participants allocated to VR groups will be trained to use a head-mounted display (HMD) that immerses them in 3D audio-video content. The non-VR group will use a laptop displaying 2D video content. Content includes relaxing natural scenes across three calendar seasons (spring, summer, fall). Investigators will collect measures pre, during, and post intervention including patient reported outcomes (PROs) of pain, anxiety, depression, fatigue. Additionally, investigators will assess the feasibility, acceptability and safety of VRAGI use in a home setting. Trial Registration Number #Pro00114598 Strengths and Limitations
- This study uses a novel design that combines the use of immersive Virtual Reality (VR) technology with guided imagery processes to treat chronic pain in advanced cancer patients.
- Investigators propose a reproducible intervention that can be self-administered in a home setting, thus eliminating the need for trained personnel, transportation modalities, or healthcare facilities.
- VR content will be preloaded onto HMDs, thus eliminating the need for access to the internet and decreasing the variability of the intervention.
- Investigators will collect patient reported outcomes (PROs) on pain, anxiety, depression, fatigue, and opioid use, but not continuous user feedback or biofeedback.
- This study focuses on patients \< 65 years of age with advanced cancer. This allows the study to focus on a large group of patients but may limit the overall generalizability of the findings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2022
CompletedFirst Posted
Study publicly available on registry
April 27, 2022
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedMarch 19, 2025
March 1, 2025
1.7 years
April 13, 2022
March 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Chane in Pain score
Change in pain interference as assessed with the Brief Pain Inventory (BPI) \[ Time Frame: Pre-Intervention(baseline), weekly at the end of week 1, 2, 3, and week 6\] Pain will be assessed with the Brief Pain Inventory (BPI). Patients will rate their pain from 0=no pain to 10=worst pain imaginable in response to items such as "average pain," "worst pain" and "least pain" over the last 7 days and "pain right now". An average of the responses to these items is used to create a single pain severity score.
End of week 1,2, 3 and 6
Secondary Outcomes (6)
Change in Anxiety score, Edmonton Symptom Assessment Scale (ESAS)
end of week 1, 2, 3 and 6
Change in Depression score, Edmonton Symptom Assessment Scale (ESAS)
end of week 1, 2, 3 and 6
Percentage reduction in opioid use
Daily assessed In a 6-week period. Comparing the change from study baseline to Day 7, Day 14, Day 21 and Day 42 in MME of prescribed medication.
Proportion of participants that completed intervention per study protocol.
Assessed at the end 6 weeks
Proportion of participants that develop adverse events.
Assessed on Day 1 and then weekly at end of week 1, 2 and 3
- +1 more secondary outcomes
Study Arms (4)
Virtual Reality Assisted Guided Imagery (VRAGI )
ACTIVE COMPARATOR20 participants will be randomized to this arm. Participants in this arm will experience the immersive VR guided imagery on VR Head Mounted Displays (Meta Quest 2). They will experience video content and the accompanying guided imagery and nature soundscapes.
Virtual Reality No Guided Imagery or other audio ( VR No GI or other audio)
SHAM COMPARATOR20 participants will be randomized to this arm. Participants in this arm will experience the immersive VR visual content on VR Head Mounted Displays (Meta Quest 2) but will not experience the accompanying guided imagery narration or nature soundscapes.
Laptop Assisted Guided Imagery (Laptop AGI)
ACTIVE COMPARATOR20 participants will be randomized to this arm. Participants in this arm will experience the VR content on laptops. They will not receive the VRHMDs. They will experience video content and the accompanying guided imagery and nature soundscapes on a laptop.
Laptop no Guided Imagery or other audio (Laptop no GI or other audio)
SHAM COMPARATOR20 participants will be randomized to this arm. Participants in this arm will experience the VR content on laptops. They will not receive the VRHMDs. They will experience only the video content on a laptop and will no experience the accompanying guided imagery or nature soundscapes.
Interventions
The visual landscape consists of a computer-generated immersive virtual world with nature-based imagery (i.e., trees, birds, mountains, water) and accompanying soundscapes with guided imagery.
Eligibility Criteria
You may qualify if:
- \> 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prisma Health-Upstatelead
- Clemson Universitycollaborator
Study Sites (3)
Clemson University
Clemson, South Carolina, 29634, United States
Watermark Counseling
Columbia, South Carolina, 29201, United States
Prisma Health
Greenville, South Carolina, 29605, United States
Related Publications (4)
Birckhead B, Eberlein S, Alvarez G, Gale R, Dupuy T, Makaroff K, Fuller G, Liu X, Yu KS, Black JT, Ishimori M, Venuturupalli S, Tu J, Norris T, Tighiouart M, Ross L, McKelvey K, Vrahas M, Danovitch I, Spiegel B. Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial. BMJ Open. 2021 Jun 15;11(6):e050545. doi: 10.1136/bmjopen-2021-050545.
PMID: 34130965BACKGROUNDZeng Y, Zhang JE, Cheng ASK, Cheng H, Wefel JS. Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419871108. doi: 10.1177/1534735419871108.
PMID: 31441352BACKGROUNDBanos RM, Espinoza M, Garcia-Palacios A, Cervera JM, Esquerdo G, Barrajon E, Botella C. A positive psychological intervention using virtual reality for patients with advanced cancer in a hospital setting: a pilot study to assess feasibility. Support Care Cancer. 2013 Jan;21(1):263-70. doi: 10.1007/s00520-012-1520-x. Epub 2012 Jun 13.
PMID: 22688373BACKGROUNDHartshorn G, Browning M, Chalil Madathil K, Mau F, Ranganathan S, Todd A, Bertrand J, Maynard A, McAnirlin O, Sindelar K, Hernandez R, Henry Gomez T. Efficacy of virtual reality assisted guided imagery (VRAGI) in a home setting for pain management in patients with advanced cancer: protocol for a randomised controlled trial. BMJ Open. 2022 Dec 5;12(12):e064363. doi: 10.1136/bmjopen-2022-064363.
PMID: 36576188DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Teny Henry Gomez, MD
Prisma Health-Upstate
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- The participants, care providers and investigators will be blinded. Randomization will be done via REDCap software
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2022
First Posted
April 27, 2022
Study Start
June 1, 2023
Primary Completion
February 28, 2025
Study Completion
February 28, 2025
Last Updated
March 19, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
Data from this study will only be accessible for to the investigators in this team. We do not plan to share IPD with other researchers.