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

NCT ID: NCT07310004

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Biopsy Anxiety Pain

Keywords

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Breast Biopsy Virtual Reality Mindfulness Pain Reduction Anxiety Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual Reality (VR) Mindful App

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Standard Calming Music

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality (VR) Mindful App

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

Intervention Type OTHER

Standard Calming Music

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Westwood

Los Angeles, California, United States

Site Status

Countries

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United States

Central Contacts

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Taylor L Johnson

Role: CONTACT

Phone: 310-889-4607

Email: [email protected]

Antonia Petruse

Role: CONTACT

Email: [email protected]

Facility Contacts

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Taylor L Johnson

Role: primary

Other Identifiers

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24-6080

Identifier Type: -

Identifier Source: org_study_id