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 — 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.

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 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.

Primary Outcome Measure

Anxiety [ Time Frame: perioperatively/periprocedurally ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
WestwoodLos AngelesCalifornia90095
Taylor L Johnson
310-889-4607

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