The Effect of Diabetes Education Digital Games and Video Animation on Quality of Life

November 11, 2024 updated by: Gamze Tınmaz Pehlivan, Pamukkale University

The Effect of Diabetes Education Given to Children With Type 1 Diabetes Mellitus With Digital Games and Video Animation on Quality of Life

This research will be conducted to evaluate the effect of digital game and video animation-based diabetes education on the quality of life of children with Type 1 Diabetes. HbA1c, diabetes knowledge and Quality of Life Scale in Children with Diabetes (PedsQL 3.0) score will be taken into consideration when evaluating the quality of life of children with type 1 diabetes.

Study Overview

Detailed Description

This research was conducted to examine the effects of diabetes education given to children with Type 1 Diabetes Mellitus with digital game and video animation on quality of life and metabolic control. The study is a single-blind, randomized controlled trial. It was conducted with a total of 55 children with Type 1 Diabetes Mellitus, including the experimental (n=27) and control group (n=28). Diabetes education was given to the experimental group with digital games and video animations. Data were collected before the training, at the 3rd and 6th months after the training. Research data were collected with "Descriptive Information Form", "Quality of Life Scale in Children with Diabetes Mellitus" and "Metabolic Control Parameters Follow-up Form". Children in the control group received routine outpatient examination/check-up and diabetes education by a diabetes nurse. Children in the intervention group were given digital game and video animation-based training, as well as routine outpatient examination/check-up and training given by a diabetes nurse.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Denizli, Turkey
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: Control Group
The control group received routine nursing care in the endocrine policlinic.
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:
  • digital game, video animation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: Baseline, 3. and 6. months
Measuring the changes in HbA1c levels of children with type 1 diabetes before training and at the 3rd and 6th months after training.
Baseline, 3. and 6. months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3. and 6. months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Sebahat ALTUNDAĞ, AssocProfDr., Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2022

Primary Completion (Actual)

May 15, 2023

Study Completion (Actual)

September 15, 2023

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Estimated)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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