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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05649553
• Other study ID #: GPehlivan
• Secondary ID: Sebahat ALTUNDAG
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: November 2023
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 15, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• digital game and video animation based diabetes education
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.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Measuring the changes in HbA1c levels of children with type 1 diabetes before training and at the 3rd and 6th months after training. HbA1c was measured from blood values measured every 3 months.	Baseline, 3. and 6. months
Secondary	Changes in quality of life	Measuring the changes in quality of life of children with type 1 diabetes before training and at the 3rd and 6th months after training. Quality of life was measured with the "Quality of Life Scale in Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)	Baseline, 3. and 6. months