- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05649553
The Effect of Diabetes Education Digital Games and Video Animation on Quality of Life
The Effect of Diabetes Education Given to Children With Type 1 Diabetes Mellitus With Digital Games and Video Animation on Quality of Life
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Denizli, Turkey
- Pamukkale University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children's willingness to participate in the research (written consent of their parents, verbal consent was obtained from the children),
- Being between the ages of 8-12,
- Having been diagnosed with Type 1 Diabetes Mellitus at least 1 year ago
- To have regular follow-ups,
- No communication disability (speech, hearing, vision problems)
- It means having a device (computer) with internet connection at home and being able to use it.
Exclusion Criteria:
- Having any chronic disease together with diabetes,
- Using an insulin pump
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
The control group received routine nursing care in the endocrine policlinic.
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Experimental: Intervention Group
Experimental: Intervention Group Application of the Introductory Information Form and the "Quality of Life Scale in Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)" test Giving digital game and video animation-based diabetes education to the children in the experimental group, in addition to the education given by the diabetes nurse, Applying the first post-training follow-up test to children in the experimental and control groups 3 months after the training. Applying the post-training-2nd follow-up test to the children in the experimental and control groups 6 months after the training. |
While creating the digital game and video animation, an agreement was made with a software company and this company was responsible for the software and repair of the game.
Digital games and video animations cover the basic educational topics of Type 1 diabetes.
Expert opinions were received from experts in the field of Child Health and Disease Nursing to ensure the suitability of the content of the educational material.
The name of the game site and how to use it were explained to the children in the intervention group by the researcher.
In addition, children in the intervention group were given usernames and passwords to log in to the site.
Game Sections; What is Diabetes?
Medical Nutrition Treatment in Diabetes, Insulin Treatment and Application, Exercise and Physical Activity in Diabetes, Complications of Type 1 Diabetes Mellitus, Diabetes Management at School.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in HbA1c
Time Frame: Baseline, 3. and 6. months
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Measuring the changes in HbA1c levels of children with type 1 diabetes before training and at the 3rd and 6th months after training.
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Baseline, 3. and 6. months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in quality of life
Time Frame: Baseline, 3. and 6. months
|
Measuring the changes in quality of life of children with type 1 diabetes before training and at the 3rd and 6th months after training.
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Baseline, 3. and 6. months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sebahat ALTUNDAĞ, AssocProfDr., Pamukkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPehlivan
- Sebahat ALTUNDAĞ, Assoc. Prof. (Other Identifier: Pamukkale University)
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
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