Breast Disease, Breast Neoplasms Breast Diseases, Breast Neoplasms
Conditions
Interventions
During the breast biopsy (Cohort A: vacuum-assisted biopsy or Cohort B: core needle biopsy), participants will wear a VR headset and watch VR videos throughout the procedure.
D000076142, D062005
Virtual Reality, Biopsy Large-Core Needle
Sponsors
Isogai Ayaka
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older. 2. Female patients. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Presence of a breast tumor requiring a needle biopsy to be performed under ultrasound guidance. 5. Ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients scheduled to undergo a tissue biopsy of the axilla. 2. Patients scheduled to undergo fine-needle aspiration (FNA) or cytology of the breast or axilla on the same day as the tissue biopsy. 3. Patients with a history of breast surgery. 4. Patients with a history of breast tissue biopsy. 5. Patients who are currently pregnant or breastfeeding. 6. Patients deemed to have limitations in vision, hearing, or cognition that may affect participation in this study. 7. Patients with a history of epilepsy, or those who have experienced loss of consciousness or epilepsy-related symptoms in the past. 8. Patients currently taking (including as-needed use) antidepressants, anxiolytics, or antiepileptic medications. 9. Patients considered to have claustrophobia. 10. Patients using implantable medical devices such as cardiac pacemakers or defibrillators, or those who require the use of a hearing aid during the examination. 11. Patients with suspected infectious symptoms or communicable diseases, particularly eye infections (e.g., conjunctivitis), or skin/scalp conditions. 12. Patients judged to lack the ability to understand the content of the informed consent document. 13. Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigator. 14. Patients who requested a prior virtual reality (VR) experience and, based on the experience, were considered unable to participate in the study. (If patients did not request the prior VR experience, it may be omitted.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of using VR during biopsy | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pain level before and after the procedure, Change in anxiety level before and after the procedure, Amount of local anesthetic used, Time taken to acclimate to VR after viewing begins, Tolerability of wearing the VR headset, Success rate of the biopsy | — |
Contacts
Public ContactAyaka Isogai
Nagoya City University Hospital
Outcome results
None listed