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

NCT ID: NCT06296147

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2026-05-01

Brief Summary

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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality Headset

Intervention Type: OTHER

The interventions are for supportive care ONLY.

Standard of Care

Intervention Type: OTHER

Participant will undergo a transperineal prostate biopsy.

Aromatherapy

The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.

Group Type: EXPERIMENTAL

Aromatherapy Patch

Intervention Type: OTHER

The interventions are for supportive care ONLY.

Standard of Care

Intervention Type: OTHER

Participant will undergo a transperineal prostate biopsy.

Virtual Reality and Aromatherapy

This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure.

Group Type: EXPERIMENTAL

Virtual Reality Headset

Intervention Type: OTHER

The interventions are for supportive care ONLY.

Aromatherapy Patch

Intervention Type: OTHER

The interventions are for supportive care ONLY.

Standard of Care

Intervention Type: OTHER

Participant will undergo a transperineal prostate biopsy.

Standard of Care

Participant will undergo transperineal prostate biopsy as standard of care.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Participant will undergo a transperineal prostate biopsy.

Interventions

Virtual Reality Headset

The interventions are for supportive care ONLY.

Intervention Type: OTHER

Aromatherapy Patch

The interventions are for supportive care ONLY.

Intervention Type: OTHER

Standard of Care

Participant will undergo a transperineal prostate biopsy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Bruce Jacobs

Assistant Professor, University of Pittsburgh School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce Jacobs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center Shadyside Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Divya Natesan

Role: CONTACT

din15@pitt.edu

(412) 692-4100

Facility Contacts

Divya Natesan, BS

Role: primary

din15@pitt.edu

John Myrga, MD

Role: backup

myrgajm@upmc.edu

Other Identifiers

STUDY23080006

Identifier Type: -

Identifier Source: org_study_id