Evaluation or excision of breast lesions with benign or uncertain malignant potential
Conditions
Interventions
Group 1: Intervention group: Patients undergoing ultrasound-guided vacuum-assisted breast biopsy while wearing the CE-marked VR headset HypnoVR®.
Group 2: Control group: Patients undergoing the same p
Sponsors
Department für Frauengesundheit, Universitäts-Frauenklinik
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Sufficient knowledge of German (spoken and written) for independent communication and for understanding the study information and informed consent form Written informed consent after explanation Planned outpatient ultrasound-guided vacuum-assisted breast biopsy under local anaesthesia Sonographically clearly localizable lesion No contraindication to local anaesthetic
Exclusion criteria
Exclusion criteria: Insufficient knowledge of German (spoken and written) preventing understanding of the study information or provision of informed consent Expected lack of patient compliance or inability of the patient to understand the purpose and objectives of the clinical trial Missing patient consent Needle or claustrophobia Advanced dementia or cognitive impairment (clinical assessment: inability to provide informed consent or to follow instructions) Pregnancy Clinically relevant coagulation disorder (INR >1.5; platelet count <100,000/µL) Acute infection in the biopsy area with erythema Neurological pre-existing conditions (migraine, epilepsy, known motion sickness) Eye conditions significantly impairing the use of the VR headset (e.g., advanced macular degeneration, severe cataract) Positional vertigo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity, measured using the Visual Analogue Scale (VAS) on a scale from 0 (no pain) to 10 (worst imaginable pain); assessed preoperatively, immediately postoperatively, approximately 30 minutes after the procedure, and one day after the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anxiety (State-Trait Anxiety Inventory, STAI) Tolerance and tolerability of the VR headset (Simulator Sickness Questionnaire, SSQ) Patient satisfaction with care at the end of the hospital stay (ZUF-8) Staff satisfaction with the VR headset (MISS) Intraoperative stress (heart rate and skin conductance measurement via smartwatch) QUIPS questionnaire (Quality Improvement in Postoperative Pain Management questionnaire) Economic questionnaire (recommendation rate) | — |
Countries
Germany
Contacts
Public ContactDr. med. Bettina Böer
Department für Frauengesundheit, Universitäts-Frauenklinik
Outcome results
None listed