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Time and quality assessment of pre-surgical and pre-anaesthesia informed consent comparing a virtual reality application to standard written information - a prospective, randomised controlled trial.

Time and quality assessment of pre-surgical and pre-anaesthesia informed consent comparing a virtual reality application to standard written information - a prospective, randomised controlled trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00029225
Enrollment
100
Registered
2022-08-17
Start date
2022-08-23
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

patients scheduled fo elective orthopaedic surgery or orthopaedic operations under general anaesthesia

Interventions

Group 1: Orthopaedic patients who receive the customary, paper based informed consent as well as a personal medical consultation Group 2: Orthopaedic patients who receive informed consent through a vi

Sponsors

XRSynergies GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patient consent, elective surgery scheduled at the Orthopaedic Hospital Vienna Speising, age >18 years, no exclusion criteria met

Exclusion criteria

Exclusion criteria: patient refuse participation, known epilepsy, known vertigo-diseases (e.g. Morbus Menière, benign paroxysmal positional vertigo), other known diseases of the vestibular system, known psychiatric diseases (e.g. anxiety disorders, dementia, bipolar disorder, autism), blindness or known impairment of the 3-dimensional vision, implanted medical devices (e.g. cardiac pacemakers, implantable Cardioverter-Defibrillator, cochlea implants), known allergy to a material component of the Virtual Reality glasses, active skin conditions in the head- or face-area, known instabilities of the cervical spine

Design outcomes

Primary

MeasureTime frame
Assessment of patient-doctor-interaction time for the conduction of informed consent using a Virtual Reality application compared to conventional, paper-based informed consent

Secondary

MeasureTime frame
Patient satisfaction with a Virtual Reality device for the conduction of informed consent

Countries

Austria

Contacts

Public ContactJochen Hofstätter

Michael-Ogon-Labor für Orthopädische Forschung

researchlab@oss.at+431801821304

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026