Clinical trial · Interventional
Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatherapy Patch | Other | — | UNRESOLVED |
| Standard of Care | Other | — | UNRESOLVED |
| Virtual Reality Headset | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Virtual Reality Device
- description
- The VR device used is the Flowly biofeedback virtual headset. This device uses calming immersive virtual worlds along with breathing exercises and a heart rate monitor to guide patients through meditated breathing exercises. The Flowly app is based on a smartphone which will be purchased through the department and used by all participants. The account used is a generic account for our department. No patient information or individualized accounts will be needed. No patient information or data will be collected.
- interventionNames
- Other: Virtual Reality Headset
- Other: Standard of Care
- type
- EXPERIMENTAL
- label
- Aromatherapy
- description
- The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.
- interventionNames
- Other: Aromatherapy Patch
- Other: Standard of Care
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available