Virtual Reality vs. Music Relaxation for Reducing Anxiety and Pain During Breast Biopsies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality (VR) Mindful App, Standard Calming Music.
- Who it may be relevant to
- Registry conditions: Breast Biopsy, Anxiety, Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Virtual Reality (VR) Mindful App
Patients will wear a Virtual Reality (VR) headset and use an application called CS VR Mindful Meditation App. - Other Standard Calming Music
Patients will listen to standard calming music played in the room.
Primary outcome measures
- Anxiety [Time frame: perioperatively/periprocedurally]
- Pain Level [Time frame: perioperatively/periprocedurally]
Secondary outcome measures (2)
- Physiological Markers [Time frame: During Biopsy]
- Satisfaction Scores [Time frame: immediately after the intervention/procedure/surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Westwood — Los Angeles
Identifiers
NCT: NCT07310004 · 24-6080