NCT06296147 · University of Pittsburgh
Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
What this study is about
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 the usual treatment (SOC).
View original scientific 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.
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)
This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment.
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)
This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment.
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)
This outcome will be measured in the survey on a likert scale from least (0) to most (10) fear, anxiety, and embarassment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Pittsburgh, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2026 · Source of record for eligibility and locations