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Completed
NCT06296147
Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 208
Sponsor: University of Pittsburgh
Location: University of Pittsburgh Medical Center Shadyside Hospital Pittsburgh Pennsylvania
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
Source: ClinicalTrials.gov (NCT06296147). StuddyBuddy aggregates publicly available trial information.