A Randomized, Controlled Trial: Impact on Patient Experience in Patients Assigned to Virtual Reality Headset; Aromatherapy Patch; Virtual Reality + Aromatherapy; or Standard of Care for Transperineal Prostate Biopsy
University of Pittsburgh
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.
Description
This is a single-center, randomized controlled trial comparing the use of a virtual reality (VR) device vs. an aromatherapy patch vs. VR+aromatherapy vs. standard of care as a non-anesthetic pain management tool during a transperineal prostate biopsy (TPBx). 208 patients who express interest in participating in the trial will be consented via Redcap. Patients will be centrally, dynamically randomized in a 1:1:1:1 ratio to one of the treatment groups or control group. There will be no subgroup stratification. The randomization will be predetermined by participant ID number. There will be a sea…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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 * Patien…
Interventions
- OtherVirtual Reality Headset
The interventions are for supportive care ONLY.
- OtherAromatherapy Patch
The interventions are for supportive care ONLY.
- OtherStandard of Care
Participant will undergo a transperineal prostate biopsy.
Location
- University of Pittsburgh Medical Center Shadyside HospitalPittsburgh, Pennsylvania