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Recruiting NCT06296147

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

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Headset, Aromatherapy Patch, Standard of Care.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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)]
  • 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. [Time frame: 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. [Time frame: immediately after the biopsy (up to 30 minutes)]
Secondary outcome measures (2)
  • Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure. [Time frame: 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. [Time frame: during the biopsy procedure (up to 30 minutes)]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Pittsburgh Medical Center Shadyside Hospital — Pittsburgh

Identifiers

NCT: NCT06296147 · STUDY23080006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗