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
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Pennsylvania
University of Pittsburgh Medical Center Shadyside Hospital
RECRUITING
Pittsburgh
Contact Information
Primary
Divya Natesan
din15@pitt.edu
(412) 692-4100
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 208
Treatments
Experimental: Virtual Reality Device
The VR device used is the Flowly biofeedback virtual headset. This device uses calming immersive virtual worlds along with breathing exercises and a heart rate monitor to guide patients through meditated breathing exercises. The Flowly app is based on a smartphone which will be purchased through the department and used by all participants. The account used is a generic account for our department. No patient information or individualized accounts will be needed. No patient information or data will be collected.
Experimental: Aromatherapy
The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.
Experimental: Virtual Reality and Aromatherapy
This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure.
Active_comparator: Standard of Care
Participant will undergo transperineal prostate biopsy as standard of care.
Related Therapeutic Areas
Sponsors
Leads: University of Pittsburgh