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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT06296147
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 20, 2024
Status verified
Jan 2026
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
208 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

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. [ Time Frame: immediately after the biopsy (up to 30 minutes) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical Center Shadyside HospitalPittsburghPennsylvania15232
Divya Natesan, BS
[email protected]
John Myrga, MD
[email protected]
Bruce Jacobs, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Pittsburgh Medical Center Shadyside Hospital· Pittsburgh, PA

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