Clinical trial · Interventional
The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures
NCT05042999CI-TRIAL-00065996VRBBcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast biopsy procedure.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oculus Go Virtual Reality Goggles | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Virtual Reality Goggles
- description
- Patients randomized to the intervention group will undergo their procedure as standard of care but will wear the Oculus Go Goggles and experience a virtual reality simulation. The simulation is a non-interactive polar theme video.
- interventionNames
- Device: Oculus Go Virtual Reality Goggles
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients randomized to the control group will undergo their procedure as standard of care without the use of virtual reality goggles.
Primary outcomes (1)
- measure
- Subjective Pain Assessment: Visual Analog Scale
- timeFrame
- Immediate post-procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent is obtained from the patient * Females who are 18 years of age * Patient is scheduled for preoperative ultrasound guided breast biopsy procedure Exclusion Criteria: * Patient is scheduled for a stereotactic biopsy procedure * The patient has motion sickness * The patient has severe cognitive disabilities or language barriers that inhibit study form completion in English * The patient has a history of seizures or epilepsy * Refusal of patient to sign consent
References
Publications (11)
- BACKGROUNDBreivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16. PMID 18487245
- BACKGROUNDChirico A, Lucidi F, De Laurentiis M, Milanese C, Napoli A, Giordano A. Virtual Reality in Health System: Beyond Entertainment. A Mini-Review on the Efficacy of VR During Cancer Treatment. J Cell Physiol. 2016 Feb;231(2):275-87. doi: 10.1002/jcp.25117. PMID 26238976
- BACKGROUNDCosta WA, Monteiro MN, Queiroz JF, Goncalves AK. Pain and quality of life in breast cancer patients. Clinics (Sao Paulo). 2017 Dec;72(12):758-763. doi: 10.6061/clinics/2017(12)07. PMID 29319722
- BACKGROUNDHornblow AR, Kidson MA. The visual analogue scale for anxiety: a validation study. Aust N Z J Psychiatry. 1976 Dec;10(4):339-41. doi: 10.3109/00048677609159523. No abstract available. PMID 1071419
- BACKGROUNDMahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8. PMID 19272275
- BACKGROUNDMalloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13. PMID 20691523
- RESULTBloomquist EV, Ajkay N, Patil S, Collett AE, Frazier TG, Barrio AV. A Randomized Prospective Comparison of Patient-Assessed Satisfaction and Clinical Outcomes with Radioactive Seed Localization versus Wire Localization. Breast J. 2016 Mar-Apr;22(2):151-7. doi: 10.1111/tbj.12564. Epub 2015 Dec 23. PMID 26696461
- Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.