Virtual Reality vs. Music Relaxation for Reducing Anxiety and Pain During Breast Biopsies

NCT07310004 | Recruiting DMC

• 1 other identifier: 24-6080
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of a Virtual Reality (VR) application computer simulation \[(CS) VR Mindful Meditation App')\] versus music relaxation in reducing anxiety and pain in women undergoing breast biopsies. Participants will be randomized into three groups: VR, music relaxation, or standard care. Anxiety and pain will be measured using validated scales, and an optional physiological marker may be collected to assess stress levels. Participants will also be asked about their satisfaction with the intervention received, along with procedure-specific questions.

Conditions

Breast Biopsy; Anxiety; Pain

Keywords

Breast Biopsy; Virtual Reality; Mindfulness; Pain Reduction; Anxiety Reduction

Outcome Measures

Primary Outcomes (2)

• Anxiety

  Pre- and post-procedure anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The scale uses a four point Likert scale ranging from "not at all" to "very much so." The score range is from 20-80 with a higher score indicating more anxiety. The change in anxiety scores (pre- to post-procedure) will be compared across the three groups (VR, music relaxation, and control).

  perioperatively/periprocedurally

• Pain Level

  Pain will be measured using the Visual Analog Scale (VAS) before and after the procedure. The scale is a subjective measure where individuals mark pain intensity on a 100mm line. typically from "no pain" (0) to "wort possible pain" (100). Higher score is worse. The change in pain scores (pre- to post-procedure) will be analyzed. The

  perioperatively/periprocedurally

Secondary Outcomes (2)

• Physiological Markers

  During Biopsy

• Satisfaction Scores

  immediately after the intervention/procedure/surgery

Study Arms (3)

VR Intervention

EXPERIMENTAL

Patients will wear a Virtual Reality (VR) headset during the breast biopsy. They will use the CS VR Mindful Meditation App. Anxiety and pain will be measured using validated scales, and an optional physiological marker may be collected to assess stress levels. Participants will also be asked about their satisfaction with the intervention received, along with procedure-specific questions.

Other: Virtual Reality (VR) Mindful App

Music Intervention

ACTIVE COMPARATOR

Patients will listen to standard calming music during the breast biopsy from the computer/speakers in the room. Anxiety and pain will be measured using validated scales, and an optional physiological marker may be collected to assess stress levels. Participants will also be asked about their satisfaction with the intervention received, along with procedure-specific questions.

Other: Standard Calming Music

No Intervention

NO INTERVENTION

Patients will have no intervention and complete the breast biopsy as standard of care. Anxiety and pain will be measured using validated scales, and an optional physiological marker may be collected to assess stress levels. Participants will also be asked about their satisfaction with the intervention received, along with procedure-specific questions.

Interventions

Virtual Reality (VR) Mindful App OTHER

Patients will wear a Virtual Reality (VR) headset and use an application called CS VR Mindful Meditation App.

VR Intervention

Standard Calming Music OTHER

Patients will listen to standard calming music played in the room.

Music Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 18 years or older.
• Scheduled for an ultrasound-guided or stereotactic breast biopsy.
• Capable of understanding and providing informed consent.

You may not qualify if:

• Individuals with a history of epilepsy, motion sickness, or severe cognitive impairment (for the VR group).
• Use of anxiolytic medication immediately prior to the biopsy.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Westwood

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Taylor L Johnson

CONTACT

310-889-4607; taylorjohnson@mednet.ucla.edu

Antonia Petruse

CONTACT

apetruse@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial with three parallel groups: VR intervention, music relaxation, and standard care. Participants will be randomized in a 1:1:1 ratio, and interventions will last for the duration of the biopsy procedure.

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: December 30, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

US (1)