The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures

Prisma Health-Upstate60 enrolled

Overview

To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast biopsy procedure.

Breast biopsies for patients with abnormal mammograms are required to identify cancerous tissue. Currently this procedure is done with or without a local anesthetic. Patients report anxiety regarding potentially having cancer and the possibility of cancer-related procedures. Different types of biopsies may have different pain and anxiety based on their duration and complexity. This research is designed to determine if VR simulated environment can reduce pain and anxiety. The aim is to study the efficacy of a virtual environment in reducing pain and procedural anxiety. It is intended for patients undergoing an ultrasound guided breast biopsy procedure that have had an abnormal mammogram. The overall aim is to discover an efficacious nonpharmacologic method to lower pain and anxiety during a standard of care procedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Neoplasm Female

Interventions

Oculus Go Virtual Reality GogglesDEVICE

Oculus Go is a standalone portable Virtual Reality device that enables the user to immerse in different virtual environments. Non pharmacological technique to reduce pain and anxiety during a procedure.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent is obtained from the patient * Females who are 18 years of age * Patient is scheduled for preoperative ultrasound guided breast biopsy procedure Exclusion Criteria: * Patient is scheduled for a stereotactic biopsy procedure * The patient has motion sickness * The patient has severe cognitive disabilities or language barriers that inhibit study form completion in English * The patient has a history of seizures or epilepsy * Refusal of patient to sign consent

Locations (1)

Patewood Outpatient Surgery Center

Greenville, South Carolina, United States

Outcomes

Primary Outcomes

Subjective Pain Assessment: Visual Analog Scale

Pain Measured with the Visual Analog Scale. Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The individual will score their pain level by circling a number 0 - 10 both pre-operative and post-operatively. The scale range includes 0-10 scales, with \< 2 =well controlled, 2 - 5: partly controlled, \> 5: uncontrolled.

Time frame: Immediate post-procedure

Secondary Outcomes

State-Trait Anxiety Inventory (STAI: Y-6 item)

The State-Trait Anxiety Inventory uses a 4 point Likert scale to assess how much worry, tension or apprehension the subject experiences in his or her present circumstances (state anxiety) and how much anxiety represent a personality characteristic (trait anxiety). Items emphasize the frequency of particular symptoms (ranging from 1 = not at all to 4 = very much). The range of possible scores for form Y of the STAI varies from a minimum score of 20 to a maximum score of 80 on both the STAI-T and STAI-S subscales. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

Time frame: Immediate post-procedure

Patient Satisfaction

Patients in both groups will be asked to rate their satisfaction with their procedures using a five point likert scale (ranging from 1 = definitely disagree to 5 = definitely agree).

Time frame: Immediate post-procedure

Data from ClinicalTrials.gov

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