Behaviors and Mental Disorders

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Symptoms and General Pathology

Anxiety Disorders

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Pain

Breast Diseases

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Patients randomized to the intervention group will undergo their procedure as standard of care but will wear the Oculus Go Goggles and experience a virtual reality simulation. The simulation is a non-interactive polar theme video.

Patients randomized to the control group will undergo their procedure as standard of care without the use of virtual reality goggles.

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.

Oculus Go Virtual Reality Goggles

Andrea Nisonson, MD

To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast localization procedure (traditional wire, savi scout or a radiofrequency identification tag).

Needle localizations for breast cancer surgery are required to identify cancerous tissue before surgery. Currently this procedure is done with or without a local anesthetic. Patients report anxiety regarding cancer and cancer-related procedures. Different types of needle localization may have different pain and anxiety based on their duration, complexity, and invasiveness. This research is designed to determine if VR simulated environment can reduce pain and anxiety.

Our 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 localization procedure that have had an abnormal breast biopsy. The overall aim is to discover an efficacious nonpharmacologic method to lower pain and anxiety during a standard of care procedure.

VR Ultrasound Guided Breast Localization

The Use of Virtual Reality During Breast Localization Procedures

Empatica E4 watch is a wearable device that collects real-time physiological data. This wristband is equipped with photoplethysmogram sensors for computing Heart Rate (HR). Heart rate will be reported in beats per minute (bpm).

Empatica E4 watch is a wearable device that collects real-time physiological data. The photoplethysmogram sensor from the watch will measure temperature. Temperature will be reported in degrees Celsius.

Empatica E4 watch is a wearable device that collects real-time physiological data. The photoplethysmogram sensor from the watch will measure variation of volume of arterial blood under the skin resulting from the heart cycle computing Blood Volume Pulse (BVP). Blood Volume Pulse will be measured in beats min-1.

The Empatica E4 watch is a wearable device that collects real-time physiological data. The photoplethysmogram skin electrodes from the watch will capture the Galvanic Skin Response (GSR), also named Electrodermal Activity (EDA) and Skin Conductance (SC) or the measure of the continuous variations in the electrical characteristics of the skin. GSR will be reported in units of micro-Siemens (μS).

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 at baseline, pre-operative, and post-operatively. The scale range includes 0-10 scales, with \< 2 =well controlled, 2 - 5: partly controlled, \> 5: uncontrolled.

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).

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).

Clemson University

Prisma Health-Upstate

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.

Drew Epling

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.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
VR Ultrasound Guided Breast Localization	NCT04251507	Breast Neoplasm...	Oculus Go Virtu...	18 Years -	Prisma Health-Upstate
The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures	NCT05042999	Breast Neoplasm...	Oculus Go Virtu...	18 Years -	Prisma Health-Upstate

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