Virtual Reality Headset And/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
208Conditions
Prostate CancerSummary
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.
Detailed 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 sealed envelope prepared and labeled with the participant ID that will contain the information for which treatment group a participant is assigned to. Once a participant is consented and assigned an ID, the envelope will be reopened to reveal which intervention the patient will be assigned to.
All participants will take a survey immediately following the procedure and that will conclude their participation in the study.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Divya Natesan, BS
- [email protected]
Principal Investigator
- Bruce Jacobs, MD
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
Study Plan
Virtual Reality Device
EXPERIMENTAL
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.
OTHER:
Virtual Reality HeadsetDescription:
The interventions are for supportive care ONLY.OTHER:
Standard of CareDescription:
Participant will undergo a transperineal prostate biopsy.
Aromatherapy
EXPERIMENTAL
The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.
OTHER:
Aromatherapy PatchDescription:
The interventions are for supportive care ONLY.OTHER:
Standard of CareDescription:
Participant will undergo a transperineal prostate biopsy.
Virtual Reality and Aromatherapy
EXPERIMENTAL
This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure.
OTHER:
Virtual Reality HeadsetDescription:
The interventions are for supportive care ONLY.OTHER:
Aromatherapy PatchDescription:
The interventions are for supportive care ONLY.OTHER:
Standard of CareDescription:
Participant will undergo a transperineal prostate biopsy.
Standard of Care
ACTIVE_COMPARATOR
Participant will undergo transperineal prostate biopsy as standard of care.
OTHER:
Standard of CareDescription:
Participant will undergo a transperineal prostate biopsy.
Outcome Measures
Primary Outcome Measures
Levels of pain, fear, and embarrassment that each group experienced before the TPBx measured using a self-reported survey that asks about experience prior to biopsy. The survey will be provided after the procedure.
Levels of pain, fear, and embarrassment that each group experienced during the TPBx measured using a self-reported survey that asks about experience during the biopsy. The survey will be provided after the procedure.
Levels of pain, fear, and embarrassment that each group experienced after the TPBx measured using a self-reported survey that asks about experience after to biopsy. The survey will be provided after the procedure.
Secondary Outcome Measures
Proportion of patients undergoing TPBx who would be interested in using a VR device or aromatherapy patch during the procedure.
Safety and feasibility of using a VR device or aromatherapy patch during TPBx via the proportion of procedures completed successfully with no major complications or prolongations.
Timeline
Last Updated
September 19, 2024Start Date
March 6, 2024Today
January 23, 2025Completion Date ( Estimated )
November 1, 2025
Sponsors of this trial
Lead Sponsor
University of Pittsburgh
RECRUITING 
21 - 64 Years