Breast BiopsyNCT07310004
Virtual Reality vs. Music Relaxation for Reducing Anxiety and Pain During Breast Biopsies
A study testing Virtual Reality (VR) Mindful App and Standard Calming Music in people with Breast Biopsy and Anxiety, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Biopsy, Anxiety, Pain
- What is being tested?
- Virtual Reality (VR) Mindful App and Standard Calming Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged 18 years or older.
- Scheduled for an ultrasound-guided or stereotactic breast biopsy.
- Capable of understanding and providing informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Antonia Petruse contact
United States1 site, 1 recruiting
- Recruiting
Westwood
Los Angeles, California, 90095
Taylor L Johnson, 310-889-4607, taylorjohnson@mednet.ucla.edu
About this study
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
- Being tested
- Virtual Reality (VR) Mindful App, Standard Calming Music
- Keywords
- Breast Biopsy, Virtual Reality, Mindfulness, Pain Reduction, Anxiety Reduction
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) Mindful AppOther
Patients will wear a Virtual Reality (VR) headset and use an application called CS VR Mindful Meditation App.
Standard Calming MusicOther
Patients will listen to standard calming music played in the room.
| Study group | Role | What they receive |
|---|---|---|
| VR Intervention | Experimental | 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. Receives: Other: Virtual Reality (VR) Mindful App |
| Music Intervention | Active comparator | 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. Receives: Other: Standard Calming Music |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Pre- and post-procedure anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The scale uses a four point Likert scale ranging from "not at all" to "very much so." The score range is from 20-80 with a higher score indicating more anxiety. The change in anxiety scores (pre- to post-procedure) will be compared across the three groups (VR, music relaxation, and control).
Measured: perioperatively/periprocedurally
Pain Level
Pain will be measured using the Visual Analog Scale (VAS) before and after the procedure. The scale is a subjective measure where individuals mark pain intensity on a 100mm line. typically from "no pain" (0) to "wort possible pain" (100). Higher score is worse. The change in pain scores (pre- to post-procedure) will be analyzed. The
Measured: perioperatively/periprocedurally
Secondary outcomes (2)
Physiological Markers
Heart Rate Variability (RR intervals) may be recorded during the biopsy as an objective marker of anxiety and stress. This will be an optional measure and will require the patient to wear either a Polar H10 Heart Rate Sensor below the breast or a Heart Rate Sensor on the arm during the procedure.
Measured: During Biopsy
Satisfaction Scores
For participants in the VR and music relaxation groups, a 5-point Likert scale will measure their satisfaction with the intervention. The "Intervention Satisfaction Question" asks "How satisfied were you with the intervention you received?", with 1 being "Not at all satisfied" and 5 being "Extremely satisfied". In this scale, a higher score means a better outcome. There is also the option for "I received no intervention."
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start20 Jan 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast BiopsyStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310004
- Sponsor's protocol ID
- 24-6080
- Status last verified
- Jan 2026
- First submitted
- 19 Feb 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality vs. Music Relaxation for Reducing Anxiety and Pain During Breast Biopsies
- ClinicalTrials.gov ID
- NCT07310004
- Acronym / sponsor ID
- 24-6080
- Conditions
- Breast Biopsy, Anxiety, Pain
- Keywords
- Breast Biopsy, Virtual Reality, Mindfulness, Pain Reduction, Anxiety Reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR Intervention | Experimental | Other: Virtual Reality (VR) Mindful AppPatients 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. |
| Music Intervention | Active comparator | Other: Standard Calming MusicPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females aged 18 years or older.
- Scheduled for an ultrasound-guided or stereotactic breast biopsy.
- Capable of understanding and providing informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR) Mindful AppPatients will wear a Virtual Reality (VR) headset and use an application called CS VR Mindful Meditation App. | Other | VR Intervention |
| Standard Calming MusicPatients will listen to standard calming music played in the room. | Other | Music Intervention |
Primary outcome
Anxiety
Time frame: perioperatively/periprocedurally
Pre- and post-procedure anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The scale uses a four point Likert scale ranging from "not at all" to "very much so." The score range is from 20-80 with a higher score indicating more anxiety. The change in anxiety scores (pre- to post-procedure) will be compared across the three groups (VR, music relaxation, and control).
Pain Level
Time frame: perioperatively/periprocedurally
Pain will be measured using the Visual Analog Scale (VAS) before and after the procedure. The scale is a subjective measure where individuals mark pain intensity on a 100mm line. typically from "no pain" (0) to "wort possible pain" (100). Higher score is worse. The change in pain scores (pre- to post-procedure) will be analyzed. The
2 secondary outcomes
Physiological Markers
Time frame: During Biopsy
Satisfaction Scores
Time frame: immediately after the intervention/procedure/surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Breast Biopsy
Not yet recruiting
De-escalation of Axillary Dissection for Node-positive Breast Cancer
Breast Cancer by AJCC V8 Anatomic Stage, Breast Cancer
Not yet recruiting
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC)
Breast Cancer, Metastatic Breast Cancer
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
Recruiting
Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)
Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antonia Petruse contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) Mindful App and Standard Calming Music in people with Breast Biopsy and Anxiety, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taylor L Johnson (310-889-4607, taylorjohnson@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: perioperatively/periprocedurally). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.