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VR Education in Patients Undergoing Coronary Angiography

Primary Purpose

Coronary Arteriosclerosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VR educational video
Sponsored by
Adela Drozdova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Arteriosclerosis focused on measuring Virtual Reality, Education

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with indication for undergoing coronary angiography Exclusion Criteria: Visual impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard education

    VR Education

    Arm Description

    Patients will be educated about the procedure in a standard way by a doctor and a nurse

    Patients will be educated with the use of virtual reality

    Outcomes

    Primary Outcome Measures

    Quality of VR augmented eduacation assessed by a questionaire
    A questionaire with questions assessing patients' personal experience and knowledge of the procedure was prepared. This will be collected and compared to patients with a standard education.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2023
    Last Updated
    January 21, 2023
    Sponsor
    Adela Drozdova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05695547
    Brief Title
    VR Education in Patients Undergoing Coronary Angiography
    Official Title
    Non-inferiority of Virtual Reality Augmented Education in Patients Undergoing Coronary Angiography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 25, 2023 (Anticipated)
    Primary Completion Date
    January 5, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Adela Drozdova

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to compare standard education with VR augmented education in patients undergoing selective coronary angiography.
    Detailed Description
    The aim of this study is to compare standard education (doctor and nurse led) with Virtual Reality (VR) augmented education in patients prior toa selective coronary angiography. A 360° education video was prepared in the operating theatre and other areas of the hospital to make patients more comfortable with these unfamilliar places. The procedure was explained in details by a doctor and animations were used to help them to visualise the procedure. Risks and complications of the procedure were highlited along with the precautionary measures the patient need to take after the procedure. Patients coming into the One-Day Cardilogy Unit of Podlesi Hospital will be randomised into 2 groups: Standard education and VR augmented education. The VR group will be then educated using VR and will be given an opportunity to ask a physician more questions if needed. Patients will then fill in forms to assess their experience, feelings and knowledge about the procedure. Data will be then collected to assess if VR could facilitate patients' education. The investigators believe it could be a useful tool to save time of doctors and nurses which is becoming more and more precious and expensive.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Arteriosclerosis
    Keywords
    Virtual Reality, Education

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard education
    Arm Type
    No Intervention
    Arm Description
    Patients will be educated about the procedure in a standard way by a doctor and a nurse
    Arm Title
    VR Education
    Arm Type
    Experimental
    Arm Description
    Patients will be educated with the use of virtual reality
    Intervention Type
    Other
    Intervention Name(s)
    VR educational video
    Intervention Description
    Patients will be educated with our specifically made VR video in the settings of our hospital to make patients more familliar with the spaces and to explain them the procedure.
    Primary Outcome Measure Information:
    Title
    Quality of VR augmented eduacation assessed by a questionaire
    Description
    A questionaire with questions assessing patients' personal experience and knowledge of the procedure was prepared. This will be collected and compared to patients with a standard education.
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with indication for undergoing coronary angiography Exclusion Criteria: Visual impairment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karin Poloková, MUDr.
    Phone
    +420607145057
    Email
    kpolokova@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adela Drozdová, MUDr.
    Phone
    +420607147489
    Email
    drozdova.adela@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    general demographic data

    Learn more about this trial

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