Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy

University of Pittsburgh

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Other: Standard of Care; Other: Aromatherapy Patch; Other: Virtual Reality Headset

Study type: Interventional

Funder types: Other

Identifiers

NCT06296147

STUDY23080006

Details and patient eligibility

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.

Full 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.

Enrollment: 208 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 4 patient groups

Virtual Reality Device

Experimental group

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.

Treatment:

Other: Virtual Reality Headset

Other: Standard of Care

Aromatherapy

Experimental group

Description:

The aromatherapy arm will utilize one standardized patch with a peppermint/lavender scent based on prior research and experience.

Treatment:

Other: Aromatherapy Patch

Other: Standard of Care

Virtual Reality and Aromatherapy

Experimental group

Description:

This arm will combine both the Virtual Reality arm and the aromatherapy arm procedure.

Treatment:

Other: Virtual Reality Headset

Other: Aromatherapy Patch

Other: Standard of Care

Standard of Care

Active Comparator group

Description:

Participant will undergo transperineal prostate biopsy as standard of care.

Treatment:

Other: Standard of Care