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NCT05348174 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial of Virtual Reality Assisted Guided Imagery (VRAGI) for Pain in Advanced Cancer Patients.
A NA study, sponsored by Prisma Health-Upstate.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT05348174 is a NA study that has completed, run by Prisma Health-Upstate. The registered enrollment target is 41 participants.
The verdict
NCT05348174, a NA study, has completed, sponsored by Prisma Health-Upstate.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study 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
Interventions
- BEHAVIORAL Virtual Reality Assisted Guided Imagery (VRAGI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2025-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05348174
The ClinicalTrials.gov registry entry for NCT05348174 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prisma Health-Upstate, which has 67 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Virtual Reality Assisted Guided Imagery (VRAGI) is the first listed.
NCT05348174 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05348174 about?
NCT05348174 is a clinical study titled "Randomized Controlled Trial of Virtual Reality Assisted Guided Imagery (VRAGI) for Pain in Advanced Cancer Patients.". 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. Guid...
What is the current status of trial NCT05348174?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2023-06-01. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT05348174?
The interventions under investigation include: Virtual Reality Assisted Guided Imagery (VRAGI) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05348174?
This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.
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