NCT06296147

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Virtual Reality Headset	The interventions are for supportive care ONLY.
OTHER	Aromatherapy Patch	The interventions are for supportive care ONLY.
OTHER	Standard of Care	Participant will undergo a transperineal prostate biopsy.

Timeline

• Start date: 2024-05-20
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-03-06
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States