Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
Recruiting · NCT06296147 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Pittsburgh
View the official record on ClinicalTrials.gov →Interventions studied
Aromatherapy PatchStandard of CareVirtual Reality Headset
What this trial is about
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 take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Pittsburgh Medical Center Shadyside Hospital - Pittsburgh, Pennsylvania, United States