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

Phase

N/A

Condition

Urologic Cancer

Prostate Cancer, Early, Recurrent

Prostate Cancer

Treatment

Aromatherapy Patch

Virtual Reality Headset

Standard of Care

Clinical Study ID

NCT06296147

STUDY23080006

Ages > 18
Male

Study 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.

Eligibility Criteria

Inclusion

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 inthe study

Exclusion

Exclusion Criteria:

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

Study Design

Aromatherapy Patch

May 20, 2024

November 01, 2025

Study 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.

Connect with a study center

University of Pittsburgh Medical Center Shadyside Hospital
Pittsburgh, Pennsylvania 15232
United States
Active - Recruiting

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