Your session is about to expire
← Back to Search
Virtual Reality Device for Prostate Cancer
N/A
Recruiting
Led By Bruce Jacobs, MD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the biopsy procedure (up to 30 minutes)
Awards & highlights
Study Summary
This trial aims to see if using a VR headset and/or aromatherapy can help reduce patient pain, anxiety, and embarrassment during a specific medical procedure called a transperineal biopsy. The main
Who is the study for?
This trial is for individuals undergoing a transperineal prostate biopsy, typically done to diagnose prostate cancer. Participants should be willing to potentially use virtual reality (VR) headsets and aromatherapy patches during the procedure. Specific eligibility criteria are not provided, but usually include age range, health status, and no prior adverse reactions to similar interventions.Check my eligibility
What is being tested?
The study is testing whether using VR headsets and/or aromatherapy patches can help reduce pain, anxiety, and embarrassment compared to just getting the standard care during a prostate biopsy. Patients will be randomly assigned into four groups: one with VR only, one with aromatherapy only, one with both VR and aromatherapy, and a control group receiving standard care.See study design
What are the potential side effects?
While not explicitly listed for this trial, potential side effects may include discomfort or dizziness from using the VR headset and skin irritation or allergic reactions from the aromatherapy patch.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Levels of pain, fear, and embarrassment that each group experienced after the TPBx measured using a self-reported survey that asks about experience after to biopsy. The survey will be provided after the procedure.
Levels of pain, fear, and embarrassment that each group experienced before the TPBx measured using a self-reported survey that asks about experience prior to biopsy. The survey will be provided after the procedure.
Levels of pain, fear, and embarrassment that each group experienced during the TPBx measured using a self-reported survey that asks about experience during the biopsy. The survey will be provided after the procedure.
Secondary outcome measures
Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure.
Safety and feasibility of using a VR device or aromatherapy patch during TPBx via the proportion of procedures completed successfully with no major complications or prolongations.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Reality and AromatherapyExperimental Treatment3 Interventions
This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure.
Group II: Virtual Reality DeviceExperimental Treatment2 Interventions
The VR device used is the Flowly biofeedback virtual headset. This device uses calming immersive virtual worlds along with breathing exercises and a heart rate monitor to guide patients through meditated breathing exercises. The Flowly app is based on a smartphone which will be purchased through the department and used by all participants. The account used is a generic account for our department. No patient information or individualized accounts will be needed. No patient information or data will be collected.
Group III: AromatherapyExperimental Treatment2 Interventions
The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.
Group IV: Standard of CareActive Control1 Intervention
Participant will undergo transperineal prostate biopsy as standard of care.
Find a Location
Who is running the clinical trial?
University of PittsburghLead Sponsor
1,731 Previous Clinical Trials
16,307,285 Total Patients Enrolled
9 Trials studying Prostate Cancer
839 Patients Enrolled for Prostate Cancer
Bruce Jacobs, MDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
39 Total Patients Enrolled
1 Trials studying Prostate Cancer
39 Patients Enrolled for Prostate Cancer
Share this study with friends
Copy Link
Messenger