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NCT Number: NCT07310004

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Westwood

Los Angeles, California, 90095, United States

Location status: Recruiting

Location contact

Taylor L Johnson

CONTACT

[email protected]

310-889-4607

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality (VR) Mindful App

Other

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

Standard Calming Music

Other

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

Primary outcomes

  1. Anxiety

    Time frame: perioperatively/periprocedurally

    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).

  2. Pain Level

    Time frame: perioperatively/periprocedurally

    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

Secondary outcomes

  1. Physiological Markers

    Time frame: During Biopsy

    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.

  2. Satisfaction Scores

    Time frame: immediately after the intervention/procedure/surgery

    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."

Study contacts

Contact information is provided by the study sponsor or research team.

Antonia Petruse

CONTACT

[email protected]

Taylor L Johnson

CONTACT

[email protected]

310-889-4607

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 30, 2025
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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