Recruiting

VR vs. Music

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT07310004

Conditions

Breast Biopsy

Anxiety

Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality (VR) Mindful App

Standard Calming Music

Study Details

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

Study ID

NCT07310004

Start date

Jan 20, 2026

Status verified date

Jan, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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

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

Standard Calming Music

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

Primary outcome measure

  • Anxiety [ Time Frame: perioperatively/periprocedurally ]
  • Pain Level [ Time Frame: perioperatively/periprocedurally ]

Central Contacts and Locations

Central contacts

Taylor L Johnson

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

Antonia Petruse

apetruse@mednet.ucla.edu

Locations

Westwood

Recruiting

Los Angeles, California, United States, 90095

Contacts

Taylor L Johnson

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

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Feb 5, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-02-05.