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The Effect of Digital Game-Based Diabetes Education on Quality of Life of Children With Type 1 Diabetes Mellitus

Primary Purpose

Type 1 Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Digital Game Based Diabetes Education
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, Digital game, Life Quality

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Children's willingness to participate in the research (with their parents' written consent), Being between the ages of 8-12, Having been diagnosed with Type 1 diabetes at least 6 months ago, To have regular follow-ups, Children who have and can use a computer with internet connection at home will be included in the study. Exclusion Criteria: Having any chronic disease together with diabetes, Children with communication problems (speech, hearing, vision) will not be included in the study.

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Application of Introductory Information Form" and pre-test "Quality of Life in Children with Diabetes Mellitus Scale (PedsQL 3.0 Diabetes Scale)" Providing digital game-based diabetes education to the children in the intervention group in addition to the education given by the diabetes nurse Children in the intervention group play the Digital Diabetes Game Application of the post-test "Quality of Life in Children with Diabetes Mellitus Scale (PedsQL 3.0 Diabetes Scale)" Immediately after the training and 3 months after the training, the children in the intervention group will be asked to fill in the "Quality of Life in Children with Diabetes Mellitus Scale (PedsQL 3.0 Diabetes Scale)"

The control group received routine nursing care in the endocrine policlinic.

Outcomes

Primary Outcome Measures

Change in HbA1c
Measuring changes in HbA1c levels of children with type 1 diabetes before and 3 months after education

Secondary Outcome Measures

"Quality of Life Scale for Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)"
"Quality of Life Scale for Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)" score

Full Information

First Posted
December 6, 2022
Last Updated
December 18, 2022
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05649553
Brief Title
The Effect of Digital Game-Based Diabetes Education on Quality of Life of Children With Type 1 Diabetes Mellitus
Official Title
The Effect of Digital Game Based Diabetes Education Given to Children With Type 1 Diabetes Mellitus on Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 19, 2022 (Anticipated)
Primary Completion Date
February 6, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research will be conducted to evaluate the effect of digital game-based diabetes education on the quality of life of children with Type 1 Diabetes Mellitus. HbA1c, diabetes knowledge, and Quality of Life in Children with Diabetes Mellitus Scale (PedsQL 3.0) score will be taken into account in assessing the quality of life for children with type 1 diabetes.
Detailed Description
This research will be conducted to evaluate the effect of digital game-based diabetes education on the quality of life of children with Type 1 Diabetes Mellitus. This study will be conducted using a randomized controlled experimental design.The research will be carried out with children with Type 1 diabetes between the ages of 8-12, registered in the Pediatric Endocrinology Outpatient Clinic of a university hospital.The sample of the study (intervention group=26, control group=26) will consist of 52 children with type 1 diabetes. Study and control groups will be determined by simple randomization (https://www.random.org/). In the collection of data; "The Descriptive Information Form", which includes the descriptive features of children with Type 1 diabetes mellitus, created by the researcher in line with the literature information, and the "Quality of Life Scale for Children with Diabetes Mellitus (PedsQL 3.0)", developed by Varni et al. (2003), will be used. Children in the control group will be given routine outpatient examination/control and diabetes education by the diabetes nurse. In addition to the routine polyclinic examination/control and the training given by the diabetes nurse, digital game-based training will be given to the children in the intervention group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus, Digital game, Life Quality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a parallel group randomized controlled study
Masking
Participant
Masking Description
Single blinding was provided that included inclusion criteria and agreement to participate in the study.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Application of Introductory Information Form" and pre-test "Quality of Life in Children with Diabetes Mellitus Scale (PedsQL 3.0 Diabetes Scale)" Providing digital game-based diabetes education to the children in the intervention group in addition to the education given by the diabetes nurse Children in the intervention group play the Digital Diabetes Game Application of the post-test "Quality of Life in Children with Diabetes Mellitus Scale (PedsQL 3.0 Diabetes Scale)" Immediately after the training and 3 months after the training, the children in the intervention group will be asked to fill in the "Quality of Life in Children with Diabetes Mellitus Scale (PedsQL 3.0 Diabetes Scale)"
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group received routine nursing care in the endocrine policlinic.
Intervention Type
Behavioral
Intervention Name(s)
Digital Game Based Diabetes Education
Intervention Description
While creating the digital diabetes game, an agreement is made with a software company, and this company will be responsible for the software, repair, design and development of the game.The digital diabetes game covers the basic education topics of Type 1 diabetes. Expert opinion was obtained from experts in the field of Child Health and Disease Nursing for the suitability of the content of the training material. The name of the game site and how it will be used will be explained to the children in the intervention group by the researcher. In addition, the user names and passwords will be given to the children in the intervention group to enter the site. Children will be given 1 month to play with the digital diabetes game. Game Sections; What is Diabetes?Medical Nutrition Therapy in Diabetes, Insulin Therapy and Administration, Exercise and Physical Activity in Diabetes, Complications of Type 1 Diabetes Mellitus, Diabetes management at school
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Measuring changes in HbA1c levels of children with type 1 diabetes before and 3 months after education
Time Frame
Baseline and 3 months
Secondary Outcome Measure Information:
Title
"Quality of Life Scale for Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)"
Description
"Quality of Life Scale for Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)" score
Time Frame
up to 3 months after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children's willingness to participate in the research (with their parents' written consent), Being between the ages of 8-12, Having been diagnosed with Type 1 diabetes at least 6 months ago, To have regular follow-ups, Children who have and can use a computer with internet connection at home will be included in the study. Exclusion Criteria: Having any chronic disease together with diabetes, Children with communication problems (speech, hearing, vision) will not be included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze TINMAZ PEHLİVAN, MSc
Phone
+905075718002
Email
gamze_1989_g@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebahat ALTINDAĞ, AssocProfDr.
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Digital Game-Based Diabetes Education on Quality of Life of Children With Type 1 Diabetes Mellitus

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