RECRUITING

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

Conditions

Prostate Cancer Transperineal Prostate Biopsy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-20

Study Completion:2025-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06296147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

Divya Natesan

CONTACT

(412) 692-4100

din15@pitt.edu

Principal Investigator

Bruce Jacobs, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh Medical Center Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Bruce Jacobs, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-20

Study Completion Date2025-11-01

Study Record Updates

Study Start Date2024-05-20

Study Completion Date2025-11-01

Terms related to this study

Keywords Provided by Researchers

Transperineal Prostate Biopsy

Additional Relevant MeSH Terms

Prostate Cancer