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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
208
The interventions are for supportive care ONLY.
The interventions are for supportive care ONLY.
Participant will undergo a transperineal prostate biopsy.
University of Pittsburgh Medical Center Shadyside Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGLevels 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)
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.
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.
Track number of procedures completed successfully with no major complications or prolongations per the investigator's discretion.
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Time frame: during the biopsy procedure (up to 30 minutes)