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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety; Breast Biopsy
• Intervention / Treatment: Other: Virtual Reality (VR) Mindful App; Other: Standard Calming Music

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taylor L Johnson; Phone Number: 310-889-4607; Email: taylorjohnson@mednet.ucla.edu
• Study Contact Backup: Name: Antonia Petruse; Email: apetruse@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • Westwood
      • Contact: Taylor L Johnson; Phone Number: 310-889-4607; Email: taylorjohnson@mednet.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR Intervention; 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; Patients will wear a Virtual Reality (VR) headset and use an application called CS VR Mindful Meditation App.
Active Comparator: Music Intervention; 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; Patients will listen to standard calming music played in the room.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiological Markers	Heart Rate Variability (RR intervals) may be recorded during the biopsy as an objective marker of anxiety and stress. This will be an optional measure and will require the patient to wear either a Polar H10 Heart Rate Sensor below the breast or a Heart Rate Sensor on the arm during the procedure.	During Biopsy
Satisfaction Scores	For participants in the VR and music relaxation groups, a 5-point Likert scale will measure their satisfaction with the intervention. The "Intervention Satisfaction Question" asks "How satisfied were you with the intervention you received?", with 1 being "Not at all satisfied" and 5 being "Extremely satisfied". In this scale, a higher score means a better outcome. There is also the option for "I received no intervention."	immediately after the intervention/procedure/surgery

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 19, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Mindfulness; Virtual Reality; Breast Biopsy; Pain Reduction; Anxiety Reduction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: 24-6080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No