Virtual Reality vs. Music Relaxation for Reducing Anxiety and Pain During Breast Biopsies
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Jonsson Comprehensive Cancer Center
- Study ID
- NCT07310004
- Status
- Recruiting
Conditions
- Anxiety
- Breast Biopsy
- Pain
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Virtual Reality (VR) Mindful App — OTHERPatients will wear a Virtual Reality (VR) headset and use an application called CS VR Mindful Meditation App.
- Standard Calming Music — OTHERPatients will listen to standard calming music played in the room.
Study Details
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.
Key Dates
- Start date
- Jan 20, 2026
- Status verified
- Jan 2026
- Primary completion
- Jun 30, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 600 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: VR InterventionPatients 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 InterventionPatients 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 InterventionPatients 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.
Primary Outcome Measure
Anxiety [ Time Frame: perioperatively/periprocedurally ]
Central Contacts
- Taylor L Johnson310-889-4607
- Antonia Petruse
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Westwood | Los Angeles | California | 90095 |
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