Diabetes Acute Complications and Health Literacy in Children

Diabetes Clinical Trial

Official title:

The Effect of Educational Play on Diabetes Acute Complications and Health Literacy in Children: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06160063
• Other study ID #: 2023
• Status: Completed
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: June 1, 2023

Study information

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

Clinical Trial Summary

In this study, in which education on acute complications of type 1 diabetes is planned with board games based on Bandura's social learning theory, children can indirectly learn common points that they may hear about acute complications of diabetes by watching board games of other group members. In line with this theory, children's knowledge needs regarding acute complications of diabetes can be determined, and interventions can be planned to meet the determined needs of children. Thus, the level of knowledge of diabetes health literacy for acute complications of diabetes can be increased.

This study will be carried out in a randomized controlled manner to evaluate the effect of educational play in children on acute complications of diabetes and health literacy.

Description:

This study was conducted to determine the Turkish validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" and to provide a diabetes health literacy box game to 8-12 school age children diagnosed with Type 1 diabetes. It will be carried out in two stages in order to evaluate the effect of educational games on acute complications of diabetes and health literacy in children.

In the first stage of the research, a general screening methodological method will be carried out to determine the current situation by quantitative analysis of the data obtained with the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 years)".

In the second stage; Randomly determined intervention and control groups will be applied to the intervention and control groups in a quasi-experimental type at the pre-test and the 1st and 3rd months after the training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Diabetes age is at least one year

2. Regular attendance to the three-month routine outpatient clinics

3. Not having any other disease accompanying diabetes

4. The child is between 8-12 years old

Exclusion Criteria:

1. Children not coming to the given appointment

2. Children who do not play the diabetes health literacy (DISOY) board game at home

Related Conditions & MeSH terms

• Childhood
• Diabetes
• Diabetes Mellitus
• Health Literacy

Intervention

Behavioral:
• Education intervention
Board game was created in line with current literature. In each interview, it is expected that the child's negative behaviors will be transformed into positive behaviors.

Locations

Country	Name	City	State
Turkey	Istanbul Il Saglik Müdürlügü	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
University of Yalova

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" in Turkish	The Turkish validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" was carried out.; Scale items will be created by the researcher.; The scale items will be presented to expert opinion and experts will be asked to evaluate the scale according to the Davis (1992) technique. Items that need to be revised will be reviewed and the final version of the scale will be created. Children who score higher on the scale will indicate a higher level of diabetes health literacy. The scale developed within the scope of the research will be filled in by children with diabetes themselves.	6 month
Primary	Evaluation of Literacy Scale for Acute Complications of Diabetesfor Children with Type 1 Diabetes (8-12 years)	The diabetes health literacy of children with type 1 diabetes aged 8-12 years who participated in our research was evaluated with the "Literacy Scale for Acute Complications of Diabetes for Children with Type 1 Diabetes (8-12 years)" scale. The scale was applied to the participants at the first meeting. Then, diabetes education was given to the participants through games. The scale was re-administered to the participants 1 and 3 months after the training. Participants were advised to play the game at least twice between follow-ups.	Baseline, 4 weeks ve 12 weeks after randomization