RecruitingInterventional

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

NCT ID: NCT06296147Sponsor: University of PittsburghLast updated: 2026-01-16

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.

Arms & interventions

OtherVirtual Reality Headset
The interventions are for supportive care ONLY.
OtherAromatherapy Patch
The interventions are for supportive care ONLY.
OtherStandard of Care
Participant will undergo a transperineal prostate biopsy.

Outcome measures

Primary

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.
Time frame: 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.
Time frame: 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.
Time frame: immediately after the biopsy (up to 30 minutes)

Secondary

Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure.
Time frame: 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.
Time frame: during the biopsy procedure (up to 30 minutes)

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

University of Pittsburgh Medical Center Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

Recruiting

Divya Natesan, BS · Contact

din15@pitt.edu

John Myrga, MD · Contact

myrgajm@upmc.edu

Bruce Jacobs, MD · Principal Investigator