Using Virtual Reality and Aromatherapy to Ease Pain and Anxiety During Prostate Biopsy
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
This study is testing if using virtual reality and/or aromatherapy can help men feel less pain and anxiety during a prostate biopsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06296147 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a virtual reality (VR) headset and/or aromatherapy in reducing pain, anxiety, and embarrassment for patients undergoing a transperineal prostate biopsy. Participants will be randomly assigned to one of four groups: VR, aromatherapy, a combination of both, or standard care. The primary outcome will be measured through self-reported surveys immediately after the procedure, comparing the experiences of patients in each group. The goal is to determine if these non-anesthetic interventions can improve patient comfort during the biopsy process.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older who are scheduled for a transperineal prostate biopsy.
Not a fit: Patients with psychiatric conditions, severe sensory impairments, or a history of seizures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance patient comfort and reduce anxiety during prostate biopsies.
How similar studies have performed: While the use of VR and aromatherapy in medical settings is gaining attention, this specific combination for prostate biopsy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh Medical Center Shadyside Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Bruce Jacobs, MD — University of Pittsburgh
- Study coordinator: Divya Natesan
- Email: din15@pitt.edu
- Phone: (412) 692-4100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.