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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05695534
Other study ID # AGELTrinecPodlesi
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 25, 2023
Est. completion date June 30, 2024

Study information

Verified date January 2023
Source Nemocnice AGEL Trinec-Podlesi a.s.
Contact Adéla Drozdová, MUDr.
Phone +420607147489
Email drozdova.adela@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare standard education with VR augmented education in patients prior to implantation of a permanent pacemaker.


Description:

The aim of this study is to compare standard education (doctor and nurse led) with Virtual Reality (VR) augmented education in patients prior to implantation of a permanent pacemaker. 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 patients to visualise the procedure. Risks and complications of the procedure were highlited along with the precautionary measures patients 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date June 30, 2024
Est. primary completion date January 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: Patient needs to fullfill indication criteria for a pacemaker implantation - Exclusion Criteria: Visual impairment -

Study Design


Related Conditions & MeSH terms


Intervention

Other:
VR educational video
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Adela Drozdova

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 18 months
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