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VR Ultrasound Guided Breast Localization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251507
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
Clemson University
Information provided by (Responsible Party):
Prisma Health-Upstate

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Breast Neoplasm Female Device: Oculus Go Virtual Reality Goggles Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Use of Virtual Reality During Breast Localization Procedures
Estimated Study Start Date : October 30, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Virtual Reality Goggles
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.
Device: Oculus Go 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.

No Intervention: Control
Patients randomized to the control group will undergo their procedure as standard of care without the use of virtual reality goggles.



Primary Outcome Measures :
  1. Subjective Pain Assessment: Visual Analog Scale [ Time Frame: Immediate post-procedure ]
    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.


Secondary Outcome Measures :
  1. State-Trait Anxiety Inventory (STAI: Y-6 item) [ Time Frame: Immediate post-procedure ]
    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).

  2. Patient Satisfaction [ Time Frame: Immediate post-procedure ]
    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).


Other Outcome Measures:
  1. Heart Rate [ Time Frame: Immediate post-procedure ]
    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).

  2. Temperature [ Time Frame: Immediate post-procedure ]
    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.

  3. Blood Volume Pulse Signal [ Time Frame: Immediate post-procedure ]
    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.

  4. Galvanic Skin Response [ Time Frame: Immediate post-procedure ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent is obtained from the patient
  • Females ≥ 18 years of age
  • Patient is schedule for preoperative ultrasound guided breast localization procedure

Exclusion Criteria:

  • Patient is scheduled for or switched to a stereotactic localization procedure
  • The patient has motion sickness
  • The patient has severe cognitive disabilities or language barriers that inhibit study form completion in English
  • Refusal of patient to sign consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251507


Contacts
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Contact: Andrea Nisonson, MD 864-455-3076 andrea.nisonson@prismahealth.org
Contact: Krystina Yoder, MS 864-455-7416 krystina.yoder@prismahealth.org

Sponsors and Collaborators
Prisma Health-Upstate
Clemson University
Investigators
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Principal Investigator: Andrea Nisonson, MD Prisma Health-Upstate
Publications of Results:
Other Publications:
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Responsible Party: Prisma Health-Upstate
ClinicalTrials.gov Identifier: NCT04251507    
Other Study ID Numbers: Pro00092817
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prisma Health-Upstate:
Virtual Reality
Pain
Anxiety
Ultrasound Guided Needle Localization
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases