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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06296147
• Other study ID #: STUDY23080006
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Divya Natesan
• Phone: (412) 692-4100
• Email: din15[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center Shadyside Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure.	Track number of patients approached and number of patients who sign consent.	during enrollment
Secondary	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.	Track number of procedures completed successfully with no major complications or prolongations per the investigator's discretion.	during the biopsy procedure (up to 30 minutes)