- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06195020
Examining the Effect of Metaverse-Based Epilepsy Education
Examining the Effect of Metaverse-Based Epilepsy Education on Parents' Epilepsy Knowledge Level: Randomized Controlled Experimental Research
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MEHMET DURAY
- Phone Number: 02462113268
- Email: mehmetduray@gmail.com
Study Locations
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-
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Isparta, Turkey, 32200
- Mehmet Duray
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be able to use a smartphone with internet access
- Having a child diagnosed with epilepsy
Exclusion Criteria:
- Having an additional chronic disease (diabetes, chronic kidney failure, cancer, etc.) other than epilepsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
This group will be informed by sharing and using educational videos prepared in the Metaverse universe on mobile.
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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. |
Active Comparator: Control Group
This group will be informed through routine outpatient clinic service.
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This group will be informed only at the outpatient clinic.
The intervention will last 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Introductory Form Regarding Parents and the Child's Illness
Time Frame: 3 months
|
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).
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3 months
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Epilepsy Knowledge Test Developed for Parents
Time Frame: 3 months
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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".
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Application Content and Quality Evaluation by the Expert Group [DISCERN Measurement Tool (Quality of Criteria for Consumer Health Information)]
Time Frame: 3 months
|
The DISCERN measurement tool was developed by Charnock et al. (1999) to be used in evaluating the content and quality of the educational material.
The DISCERN measurement tool, which consists of three parts, contains 16 questions that question the content of the material.
The first part, consisting of eight questions, measures the reliability of the material, the second part, consisting of seven questions, measures the quality of the information provided on treatment/care options, while the third part, consisting of a single question, questions the general evaluation of the material.
In DISCERN, each question is scored from 1 to 5, where "5" indicates the suitability of the material and "1" indicates the inappropriateness of the material.
By summing the responses from each item, a score between 15 and 75 is obtained.
Article 16, which gives the general evaluation, is evaluated separately.
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3 months
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System Usability Scale (SUS)
Time Frame: 3 months
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This measurement tool will be applied to parents in evaluating the usability of the developed universe.
Created by John Brooke in 1986, this scale allows evaluation of a wide range of products and services, including hardware, software, mobile devices, websites and applications.
Five-point Likert-type scale consisting of 10 items.
The scale consists of 10 items and has a 5-point Likert-type evaluation (0: strongly disagree, 1: disagree, 2: undecided, 3: agree, 4: strongly agree).
Items 2, 4, 6, 8 and 10 in the scale are scored in reverse, and the score obtained from each participant is multiplied by 2.5 to obtain a score between 0-100.
Based on research, an SUS score above 68 is considered above average and any score below 68 is considered below average (https://www.usability.gov/how-to-and-tools/methods/system-usability
-scale.html
Access Date: 28.02.2021).
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3 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 72867572-050.01.04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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