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

Prisma Health-Upstate

Status: Completed

Conditions: Breast Neoplasm Female

Treatments: Device: Oculus Go Virtual Reality Goggles

Study type: Interventional

Funder types: Other

Identifiers

NCT05042999

Pro00112215

Details and patient eligibility

About

To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast biopsy procedure.

Full description

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent is obtained from the patient
• Females who are 18 years of age
• Patient is scheduled for preoperative ultrasound guided breast biopsy procedure

Exclusion criteria

• Patient is scheduled for a stereotactic biopsy procedure
• The patient has motion sickness
• The patient has severe cognitive disabilities or language barriers that inhibit study form completion in English
• The patient has a history of seizures or epilepsy
• 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.