Effects of a Virtual Reality Headset during Outpatient Breast Surgery under Tumescent Local Anesthesia on Pain - A Prospective Randomized Study

Effects of a Virtual Reality Headset during Outpatient Breast Surgery under Tumescent Local Anesthesia on Pain - A Prospective Randomized Study - VR_SIA_001

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040006

Enrollment

100

Registered

2026-04-27

Start date

2026-06-18

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D48.6 D25 N64.5

Interventions

Group 1: Intervention group: Patients undergoing outpatient breast surgery under tumescent local anesthesia wearing the CE-marked VR headset HypnoVR®. Group 2: Control group: Patients undergoing the s

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Sufficient German language skills (spoken and written) for independent communication and understanding of the study information and informed consent form Written informed consent after explanation No contraindication to local anesthetic Planned outpatient breast surgery under tumescent local anesthesia

Exclusion criteria

Exclusion criteria: Insufficient German language skills (spoken and written) preventing understanding of the study information or the provision of informed consent Missing patient consent Expected lack of compliance or inability of the patient to understand the purpose and objectives of the clinical trial Needle phobia or claustrophobia Advanced dementia or cognitive impairment (clinical assessment: inability to provide informed consent or follow instructions) Pregnancy Pre-existing neurological conditions (migraine, epilepsy, known motion sickness) Eye conditions that significantly impair 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)	—

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

bettina.boeer@med.uni-tuebingen.de+497071 29-82211

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026