Clinical trial NCT04251507: VR Ultrasound Guided Breast Localization
Official title: The Use of Virtual Reality During Breast Localization Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: Virtual Reality
Pain
Anxiety
Ultrasound Guided Needle Localization
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Clemson University
First posted: 2020-02-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Eligibility 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

Primary outcomes:
measure: Subjective Pain Assessment: Visual Analog Scale
timeFrame: Immediate post-procedure
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI: Y-6 item)
timeFrame: Immediate post-procedure
measure: Patient Satisfaction
timeFrame: Immediate post-procedure
Other outcomes:
measure: Heart Rate
timeFrame: Immediate post-procedure
measure: Temperature
timeFrame: Immediate post-procedure
measure: Blood Volume Pulse Signal
timeFrame: Immediate post-procedure
measure: Galvanic Skin Response
timeFrame: Immediate post-procedure
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Andrea Nisonson, MD
role: PRINCIPAL_INVESTIGATOR
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