NCT05695534

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 5, 2023

Last Update Submit

January 21, 2023

Conditions

Pacemaker DDD

Keywords

Virtual RealityEducation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Standard education

NO INTERVENTION

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

VR Education

EXPERIMENTAL

Patients will be educated with the use of virtual reality

Other: VR educational video

Interventions

VR educational videoOTHER

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.

VR Education

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Adéla Drozdová, MUDr.

CONTACT

+420607147489drozdova.adela@gmail.com

Karin Poloková, MUDr.

CONTACT

+420607145057kpolokova@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 25, 2023

Study Start

January 25, 2023

Primary Completion

January 5, 2024

Study Completion

June 30, 2024

Last Updated

January 25, 2023

Record last verified: 2023-01