Viewing Study NCT05695534


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Study NCT ID: NCT05695534
Status: UNKNOWN
Last Update Posted: 2023-01-25
First Post: 2023-01-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Use of VR in Patients' Education Prior to Implantation of PPM
Sponsor: Adela Drozdova
Organization:

Study Overview

Official Title: Use of Virtual Reality in Patients' Education Prior to Implantation of Permanent Pacemaker
Status: UNKNOWN
Status Verified Date: 2023-01
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of this study is to compare standard education with VR augmented education in patients prior to implantation of a permanent pacemaker.
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 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: