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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: immediately after the biopsy (up to 30 minutes)]

Вторичные конечные точки (2)

• Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure. [Срок оценки: 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. [Срок оценки: during the biopsy procedure (up to 30 minutes)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Pittsburgh Medical Center Shadyside Hospital — Pittsburgh

Идентификаторы

NCT: NCT06296147 · STUDY23080006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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