Use of VR in Patients' Education Prior to Implantation of PPM

Sponsor

Adela Drozdova (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05695534

Collaborator

(none)

400

Enrollment

Arms

17.1

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pacemaker DDD	Other: VR educational video	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Use of Virtual Reality in Patients' Education Prior to Implantation of Permanent Pacemaker

Anticipated Study Start Date :

Jan 25, 2023

Anticipated Primary Completion Date :

Jan 5, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard education Patients will be educated about the procedure in a standard way by a docture and a nurse
Experimental: VR Education Patients will be educated with the use of virtual reality	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.

Arm

Intervention/Treatment

No Intervention: Standard education

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

Experimental: VR Education

Patients will be educated with the use of virtual reality

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.

Outcome Measures

Primary Outcome Measures

Quality of VR augmented eduacation assessed by a questionaire [18 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: Patient needs to fullfill indication criteria for a pacemaker implantation -

Exclusion Criteria: Visual impairment

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Adela Drozdova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adela Drozdova, PI, Nemocnice AGEL Trinec-Podlesi a.s.

ClinicalTrials.gov Identifier:

NCT05695534

Other Study ID Numbers:

AGELTrinecPodlesi

First Posted:

Jan 25, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Adela Drozdova, PI, Nemocnice AGEL Trinec-Podlesi a.s.

Virtual Reality

Education

Study Results

No Results Posted as of Jan 25, 2023