Status:

UNKNOWN

Virtual Sedation During Elective Procedures in the Cathlab

Lead Sponsor:

Universitair Ziekenhuis Brussel

Collaborating Sponsors:

University Ghent

Conditions:

Anxiety

Pain

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study aims to investigate the effectiveness of virtual reality (VR) as a non-pharmacological tool against anxiety and pain during elective procedures in the catheterization laboratory (cathlab). ...

Eligibility Criteria

Inclusion

  • Undergoing elective procedure in line with the following criteria in the cathlab of the UZB: limited feedback requirements from the patient to the physician, per-formed under local anaesthesia, risk estimated as normal i.e. haemodynamically stable patients (Stable vital signs such as heart rate and blood pressure) and no expected complications, electively planned and duration expected to be between 30 minutes and two hours.
  • Agreeing to participate via signed informed consent.
  • Being at least 18 years of age.
  • Being fluent in either English, French or Dutch language.

Exclusion

  • Ailments which would make wearing of the headset uncomfortable or impossible.
  • cognitive impairment such as dementia or delirium.
  • Severe hearing impairment, as this will limit the immersion.
  • Severe visual impairment not compensated by glasses, such as blindness.

Key Trial Info

Start Date :

June 26 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 29 2024

Estimated Enrollment :

64 Patients enrolled

Trial Details

Trial ID

NCT06171620

Start Date

June 26 2023

End Date

February 29 2024

Last Update

December 14 2023

Active Locations (1)

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Universitair Ziekenhuis Brussel

Brussels, Jette, Belgium, 1090