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
About this trial
This is an interventional other trial for Coronary Arteriosclerosis focused on measuring Virtual Reality, Education
Eligibility Criteria
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
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
VR Education in Patients Undergoing Coronary Angiography
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