VR Ultrasound Guided Breast Localization
- Conditions
- Breast Neoplasm Female
- Interventions
- Device: Oculus Go Virtual Reality Goggles
- Registration Number
- NCT04251507
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- Informed consent is obtained from the patient
- Females ≥ 18 years of age
- Patient is schedule for preoperative ultrasound guided breast localization procedure
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Reality Goggles Oculus Go 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.
- Primary Outcome Measures
Name Time Method Subjective Pain Assessment: Visual Analog Scale 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
Name Time Method State-Trait Anxiety Inventory (STAI: Y-6 item) 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).
Patient Satisfaction 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).
Trial Locations
- Locations (1)
Prisma Health
🇺🇸Greenville, South Carolina, United States