Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy (NCT06296147) | Clinical Trial Compass
RecruitingNot Applicable
Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
United States208 participantsStarted 2024-05-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: immediately after the biopsy (up to 30 minutes)
2
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.
Timeframe: immediately after the biopsy (up to 30 minutes)
3
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.
Timeframe: immediately after the biopsy (up to 30 minutes)