Clinical trial NCT06160063: Diabetes Acute Complications and Health Literacy in Children
Official title: The Effect of Educational Play on Diabetes Acute Complications and Health Literacy in Children: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood
Diabetes
Health Literacy
Keywords: Childhood
Diabetes
Health Literacy
Social Learning Theory
Board Game
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 75
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized control
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Validity and reliability of the "Health Literacy Scale for Acute Complications of Type 1 Diabetes for Children (8-12 Years)" in Turkish
timeFrame: 6 month
measure: Evaluation of Literacy Scale for Acute Complications of Diabetesfor Children with Type 1 Diabetes (8-12 years)
timeFrame: Baseline, 4 weeks ve 12 weeks after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstanbul İl Sağlık Müdürlüğü
Study officials:
References: