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Trial Title: Virtual Reality Headset And/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy

NCT ID: NCT06296147

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Transperineal Prostate Biopsy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Virtual Reality Headset
Description: The interventions are for supportive care ONLY.
Arm group label: Virtual Reality Device
Arm group label: Virtual Reality and Aromatherapy

Intervention type: Other
Intervention name: Aromatherapy Patch
Description: The interventions are for supportive care ONLY.
Arm group label: Aromatherapy
Arm group label: Virtual Reality and Aromatherapy

Intervention type: Other
Intervention name: Standard of Care
Description: Participant will undergo a transperineal prostate biopsy.
Arm group label: Aromatherapy
Arm group label: Standard of Care
Arm group label: Virtual Reality Device
Arm group label: Virtual Reality and Aromatherapy

Summary: 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.

Criteria for 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Pittsburgh Medical Center Shadyside Hospital

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Status: Recruiting

Contact:
Last name: Divya Natesan, BS
Email: din15@pitt.edu

Contact backup:
Last name: John Myrga, MD
Email: myrgajm@upmc.edu

Contact backup:
Last name: Bruce Jacobs, MD

Start date: May 20, 2024

Completion date: November 1, 2025

Lead sponsor:
Agency: University of Pittsburgh
Agency class: Other

Source: University of Pittsburgh

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06296147

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