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J-Tip Study

J-Tip Study

Needle-free Lidocaine J-Tip application for pain optimization in vulvar biopsies

medical-cross
Vulvar disorders
user
Female
person-wave 18+
world
Recruiting now

Overview

Principal Investigator: Jessica DiSilvestro, MD

The goal of this study is to compare pain during a vulvar biopsy using either the needle-free J-Tip device or the standard lidocaine shot. We expect to enroll up to 106 subjects will be enrolled in this study at Tufts Medical Center.

Contact Us

user
Afshin Azimirad

Study details

Inclusion Criteria
  • People aged ≥18 years
  • Planned to undergo a vulvar biopsy in a gynecologic outpatient office at Tufts Medical Center
  • Individuals need to be able to provide informed consent
Exclusion Criteria
  • Patients actively receiving chemotherapeutic agents
  • Unable to provide informed consent
Study Requirements

We are inviting you to take part in a research study because you are having a small biopsy procedure where a tiny piece of tissue (skin) is taken from the vulva for testing. We expect that you will be in this research study for a short time during your biopsy procedure. You will also be asked to complete a brief survey the next day. You will be asked to review and sign a consent form before joining the study. You will then complete a short survey about your background, pain level, and anxiety. During your visit, you will be randomly assigned (like flipping a coin) to receive numbing medicine either through a needle-free device (J-Tip) or a standard injection. The numbing medicine will be given before your vulvar biopsy. You will be asked to rate your pain and nervousness at different times at the beginning and after the procedure using a simple scale. After the biopsy, you will complete a short survey about your experience. Your doctor will also record details about the procedure. The day after your biopsy, you will be asked to complete one more short survey about your pain and overall experience.

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