Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
Recruiting now · Not applicable
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT06296147
- Run by
- University of Pittsburgh
- People needed
- 208
- Starts
- 2024-05-20
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2026-01-16
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- University of Pittsburgh Medical Center Shadyside Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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