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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.
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
University of Pittsburgh Medical Center Shadyside Hospital
Pittsburgh, Pennsylvania, United States
Start Date
May 20, 2024
Primary Completion Date
May 1, 2026
Completion Date
May 1, 2026
Last Updated
January 16, 2026
208
ESTIMATED participants
Virtual Reality Headset
OTHER
Aromatherapy Patch
OTHER
Standard of Care
OTHER
Lead Sponsor
University of Pittsburgh
NCT06842498
NCT05691465
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04550494