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

NCT06296147 | Recruiting

• 1 other identifier: STUDY23080006
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Transperineal Prostate Biopsy

Outcome Measures

Primary Outcomes (3)

• 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.

  This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment.

  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.

  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.

  immediately after the biopsy (up to 30 minutes)

Secondary Outcomes (2)

• Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure.

  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.

  during the biopsy procedure (up to 30 minutes)

Study Arms (4)

Virtual Reality Device

EXPERIMENTAL

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.

Other: Virtual Reality Headset; Other: Standard of Care

Aromatherapy

EXPERIMENTAL

The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.

Other: Aromatherapy Patch; Other: Standard of Care

Virtual Reality and Aromatherapy

EXPERIMENTAL

This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure.

Other: Virtual Reality Headset; Other: Aromatherapy Patch; Other: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Participant will undergo transperineal prostate biopsy as standard of care.

Other: Standard of Care

Interventions

Aromatherapy Patch OTHER

The interventions are for supportive care ONLY.

Aromatherapy; Virtual Reality and Aromatherapy

Standard of Care OTHER

Participant will undergo a transperineal prostate biopsy.

Aromatherapy; Standard of Care; Virtual Reality Device; Virtual Reality and Aromatherapy

Virtual Reality Headset OTHER

The interventions are for supportive care ONLY.

Virtual Reality Device; Virtual Reality and Aromatherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient has a known psychiatric or mental illness that would impede use of the VR device or aromatherapy patch
• Patient has severe hearing or vision problems that would impair use of the VR headset (under the physician's discretion)
• Patient has a history of seizures or epilepsy or is on a medication that would lower the threshold for a seizure
• Patient has a history of reactions to noxious odors

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Bruce Jacobs, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Divya Natesan

CONTACT

(412) 692-4100; din15@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, University of Pittsburgh School of Medicine

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 6, 2024
• Study Start: May 20, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)