Status:

WITHDRAWN

Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery

Lead Sponsor:

Oncomfort

Collaborating Sponsors:

Erasme University Hospital

Conditions:

Preoperative Anxiety

Eligibility:

All Genders

18-100 years

Phase:

NA

Brief Summary

In this feasibility study, feasibility, acceptability and an initial clinical efficacy of the new module of Hypnosis and Virtual Reality (or Digital Sedation), Silva, will be evaluated. This feasibili...

Detailed Description

Subjects will be recruited during the anaesthesiology consultation preparing to an elective surgery. First, subject will be asked to self-assess anxiety and comfort. In order to evaluate anxiety, sub...

Eligibility Criteria

Inclusion

  • • Subject more than 18 years old

Exclusion

  • Deaf subject
  • Blind
  • Non-proficiency in French (Module language)
  • Psychiatric disorder
  • Head or face wounds
  • Neurological disease
  • Chronic pain and/or chronic analgesics consumption
  • Medication affecting the autonomic nervous system
  • Dizziness

Key Trial Info

Start Date :

November 10 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 20 2020

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04379882

Start Date

November 10 2020

End Date

December 20 2020

Last Update

June 30 2021

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