VR Ultrasound Guided Breast Localization

Prisma Health-Upstate

Status: Completed

Conditions: Breast Neoplasm Female

Treatments: Device: Oculus Go Virtual Reality Goggles

Study type: Interventional

Funder types: Other

Identifiers

NCT04251507

Pro00092817

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Virtual Reality Goggles

Experimental group

Description:

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.

Treatment:

Device: Oculus Go Virtual Reality Goggles

Control

No Intervention group

Description:

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