Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy

A Randomized, Controlled Trial: Impact on Patient Experience in Patients Assigned to Virtual Reality Headset; Aromatherapy Patch; Virtual Reality + Aromatherapy; or Standard of Care for Transperineal Prostate Biopsy

The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Virtual Reality Headset; Other: Standard of Care; Other: Aromatherapy Patch

Detailed Description

This is a single-center, randomized controlled trial comparing the use of a virtual reality (VR) device vs. an aromatherapy patch vs. VR+aromatherapy vs. standard of care as a non-anesthetic pain management tool during a transperineal prostate biopsy (TPBx).

208 patients who express interest in participating in the trial will be consented via Redcap. Patients will be centrally, dynamically randomized in a 1:1:1:1 ratio to one of the treatment groups or control group. There will be no subgroup stratification. The randomization will be predetermined by participant ID number. There will be a sealed envelope prepared and labeled with the participant ID that will contain the information for which treatment group a participant is assigned to. Once a participant is consented and assigned an ID, the envelope will be reopened to reveal which intervention the patient will be assigned to.

All participants will take a survey immediately following the procedure and that will conclude their participation in the study.

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Divya Natesan; Phone Number: (412) 692-4100; Email: din15@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Recruiting
      • University of Pittsburgh Medical Center Shadyside Hospital
      • Principal Investigator: Bruce Jacobs, MD
      • Contact: Divya Natesan, BS; Email: din15@pitt.edu
      • Contact: John Myrga, MD; Email: myrgajm@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is 18 years or older
• Patient is male
• Patient is due for a transperineal prostate biopsy
• Patient signed and dated informed consent form on Redcap agreeing to participate in the study

Exclusion Criteria:

• Patient has a known psychiatric or mental illness that would impede use of the VR device or aromatherapy patch
• Patient has severe hearing or vision problems that would impair use of the VR headset (under the physician's discretion)
• Patient has a history of seizures or epilepsy or is on a medication that would lower the threshold for a seizure
• Patient has a history of reactions to noxious odors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Device; 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.	Other: Virtual Reality Headset; The interventions are for supportive care ONLY.; Other: Standard of Care; Participant will undergo a transperineal prostate biopsy.
Experimental: Aromatherapy; The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.	Other: Standard of Care; Participant will undergo a transperineal prostate biopsy.; Other: Aromatherapy Patch; The interventions are for supportive care ONLY.
Experimental: Virtual Reality and Aromatherapy; This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure.	Other: Virtual Reality Headset; The interventions are for supportive care ONLY.; Other: Standard of Care; Participant will undergo a transperineal prostate biopsy.; Other: Aromatherapy Patch; The interventions are for supportive care ONLY.
Active Comparator: Standard of Care; Participant will undergo transperineal prostate biopsy as standard of care.	Other: Standard of Care; Participant will undergo a transperineal prostate biopsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment.	immediately after the biopsy (up to 30 minutes)
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.	This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment.	immediately after the biopsy (up to 30 minutes)
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.	This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment.	immediately after the biopsy (up to 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure.	Track number of patients approached and number of patients who sign consent.	during enrollment
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.	Track number of procedures completed successfully with no major complications or prolongations per the investigator's discretion.	during the biopsy procedure (up to 30 minutes)

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Bruce Jacobs, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Transperineal Prostate Biopsy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: STUDY23080006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No