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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 weeks
Treatment ~ Varies
Follow Up ~during enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and during enrollment for reporting.

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
1,723 Previous Clinical Trials
16,342,748 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being recruited for this study?

"Indeed, the details on clinicaltrials.gov indicate that this specific study is actively pursuing eligible individuals. Originally published on March 10th, 2024 and most recently revised on February 28th, 2024, the trial aims to recruit a total of 208 participants at a single designated site."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical investigation?

"Indeed, the information provided on clinicaltrials.gov highlights that this investigation is currently in need of volunteers. The trial was initially published on March 10th, 2024 and last revised on February 28th, 2024. A total of 208 participants are being sought at a single site for this research endeavor."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
Bruce Jacobs 2024. "Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06296147.
All > Paid Studies Pittsburgh
~139 spots leftby Nov 2024
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