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Clinical Trials/DRKS00029225
DRKS00029225
Completed
Phase 2

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.

XRSynergies GmbH0 sites100 target enrollmentAugust 17, 2022

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
patients scheduled fo elective orthopaedic surgery or orthopaedic operations under general anaesthesia
Sponsor
XRSynergies GmbH
Enrollment
100
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 17, 2022
End Date
April 6, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
XRSynergies GmbH

Eligibility Criteria

Inclusion Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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