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Spots Global Cancer Trial Database for Virtual Reality Headset and/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy

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Trial Identification

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

Official Title: 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

Study ID: NCT06296147

Conditions

Prostate Cancer

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

University of Pittsburgh Medical Center Shadyside Hospital, Pittsburgh, Pennsylvania, United States

Contact Details

Name: Bruce Jacobs, MD

Affiliation: University of Pittsburgh

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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