NCT06195020

Brief Summary

The research is a randomized controlled experimental study and was planned to examine the effect of metaverse-based epilepsy education on the epilepsy knowledge level of parents.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

December 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

December 21, 2023

Last Update Submit

January 5, 2024

Conditions

Keywords

Epilepsymetaverseparentknowledge level

Outcome Measures

Primary Outcomes (2)

  • Introductory Form Regarding Parents and the Child's Illness

    This form consists of 9 questions and includes descriptive characteristics of the parents (age, mother/father, education level) and information about the epilepsy disease (mother/father age, educational status, occupation, diagnosis). questions (time, medications used, sources of information about the disease).

    3 months

  • Epilepsy Knowledge Test Developed for Parents

    This test, developed by researchers in line with the literature, consists of 50 questions. Answers to each test question can be given as "true", "false" or "I don't know".

    3 months

Secondary Outcomes (2)

  • Application Content and Quality Evaluation by the Expert Group [DISCERN Measurement Tool (Quality of Criteria for Consumer Health Information)]

    3 months

  • System Usability Scale (SUS)

    3 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

This group will be informed by sharing and using educational videos prepared in the Metaverse universe on mobile.

Other: Metaverse

Control Group

ACTIVE COMPARATOR

This group will be informed through routine outpatient clinic service.

Other: Polyclinic information

Interventions

The research consists of two stages (preparation and implementation). In the first stage of the research, the educational material planned to be used in the education of parents (video of navigation in the metaverse) will be developed in the form of modules. The topics in the training materials to be developed are listed below. Module 1: Information about Epilepsy (What is epilepsy?, What are the causes of epilepsy? Module 2 Diagnostic Methods in Epilepsy (Neurological examination, blood tests, electroencephalogram, screening tests 3rd Module Treatment of Epilepsy (Things to consider in patients receiving antiepileptic drug therapy) Module 4: First Aid in Epilepsy (first aid in seizures with convulsions, first aid in seizures without convulsions) Module 5: Life with Epilepsy (Epilepsy and school, epilepsy and career choice, epilepsy and home safety, epilepsy and exercise, epilepsy and healthy nutrition, epilepsy and sleep) The intervention will last 3 months.

Experimental Group

This group will be informed only at the outpatient clinic. The intervention will last 3 months.

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be able to use a smartphone with internet access
  • Having a child diagnosed with epilepsy

You may not qualify if:

  • Having an additional chronic disease (diabetes, chronic kidney failure, cancer, etc.) other than epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Duray

Isparta, 32200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

December 21, 2023

First Posted

January 8, 2024

Study Start

January 1, 2024

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations