NCT06296147 Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
| NCT ID | NCT06296147 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 208 participants in total. It began in 2024-05-20 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Bruce Jacobs, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06296147 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06296147 currently recruiting?
Yes, NCT06296147 is actively recruiting participants. Contact the research team at din15@pitt.edu for enrollment information.
Where is the NCT06296147 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06296147 clinical trial?
NCT06296147 is sponsored by University of Pittsburgh. The principal investigator is Bruce Jacobs, MD at University of Pittsburgh. The trial plans to enroll 208 participants.
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