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

Sponsor
Pamukkale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05649553
Collaborator
(none)
52
1
2
5.8
8.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Digital Game Based Diabetes Education
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a parallel group randomized controlled studyThis study is a parallel group randomized controlled study
Masking:
Single (Participant)
Masking Description:
Single blinding was provided that included inclusion criteria and agreement to participate in the study.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Digital Game Based Diabetes Education Given to Children With Type 1 Diabetes Mellitus on Quality of Life
Anticipated Study Start Date :
Dec 19, 2022
Anticipated Primary Completion Date :
Feb 6, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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)"

Behavioral: Digital Game Based Diabetes Education
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

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

  1. Change in HbA1c [Baseline and 3 months]

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

Secondary Outcome Measures

  1. "Quality of Life Scale for Children with Diabetes Mellitus (PedsQL 3.0 Diabetes Scale)" [up to 3 months after training]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pamukkale University Denizli Turkey

Sponsors and Collaborators

  • Pamukkale University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gamze Tınmaz Pehlivan, MSc, Principal Investigator, Pamukkale University
ClinicalTrials.gov Identifier:
NCT05649553
Other Study ID Numbers:
  • GPehlivan
  • Sebahat ALTUNDAĞ, Assoc. Prof.
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 20, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gamze Tınmaz Pehlivan, MSc, Principal Investigator, Pamukkale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 20, 2022