The Effect of Kamishibai Diabetes Education on Knowledge, HbA1c, and Quality of Life in Children

NCT06535672 | Not Yet Recruiting

• 1 other identifier: 2024/99
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Children diagnosed with Type 1 Diabetes Mellitus (T1DM) initially receive intensive education with their families. Studies indicate that over time, this initial education becomes routine, reducing its effectiveness and failing to adequately address developmental stages, thus requiring repetition. Current methods involve long and intensive educational sessions in hospitals using the Childhood Diabetes Education Guide. These extended, non-interactive sessions often lead to a loss of motivation, decreased learning efficiency, and negative attitudes among patients and their families. This study aims to develop an educational tool utilizing the Kamishibai method specifically for children with T1DM aged 8-12. The Kamishibai method is designed to align with their cognitive and sensory development, promoting effective and engaging learning experiences for diabetic patients. By incorporating interactive and visually stimulating elements, Kamishibai seeks to enhance motivation and retention of diabetes education. Hypothesis 1: Children diagnosed with Type 1 DM have higher knowledge levels in the group educated with the Kamishibai method compared to those receiving routine education. Hypothesis 2: The Hemoglobin A1c parameter is lower in the Kamishibai-educated group. Hypothesis 3: The quality of life is higher in the Kamishibai-educated group. This study will assess the effectiveness of the Kamishibai method by comparing it to routine educational approaches. The detailed protocol includes technical aspects of the intervention, measurement tools, data collection methods, and statistical analysis plans to ensure a comprehensive evaluation of the method's impact on knowledge levels, HbA1c parameters, and quality of life.

Conditions

DIABETES EDUCATION

Keywords

Type 1 Diabetes Mellitus (Type 1 DM); Kamishibai method; Hemoglobin A1c (HbA1c); Pediatric diabetes education; Quality of life in children; Randomized controlled tria

Outcome Measures

Primary Outcomes (3)

• Quality of Life Assessed by the PedsQL 3.0 Child Form

  The PedsQL™ 3.0 Diabetes Module, developed by Varni et al. (2003), measures diabetes-specific quality of life in children. The Turkish validity study of this scale was conducted by Ayar and Öztürk (2016). The scale, consisting of a total of 28 items, includes five sub-dimensions: Diabetes-Related Problems (11 items) Treatment Barriers (4 items) Adherence to Treatment (7 items) Worry (3 items) Communication (3 items) The 5-point Likert scale is scored as follows: 0 = Never 1. = Rarely 2. = Sometimes 3. = Often 4. = Always The total score ranges from 0 to 100. As the total score increases, the quality of life also increases. A score of 0 indicates never a problem (100 points), 1 indicates rarely a problem (75 points), 2 indicates sometimes a problem (50 points), 3 indicates often a problem (25 points), and 4 indicates always a problem (0 points).

  At baseline, three months later, six months later (15 minutes ago)

• HbA1c Value Assessed by Blood Test Results

  HbA1c is a glycosylated hemoglobin test that provides an average level of blood glucose over a 2-3 month period, indicating the average blood glucose values.

  At baseline, three months later, six months later (15 minutes ago)

• Diabetes Knowledge Level Assessed by the Diabetes Knowledge Level Evaluation Form

  The Diabetes Knowledge Level Evaluation Form is prepared by the researchers based on literature. The form consists of 20 questions covering the following areas: What is diabetes and how is it managed? (Questions 1-3) Insulin and blood sugar control (Question 4) Healthy eating (Questions 5-7) Exercise (Questions 8-10) Management of hyperglycemia and hypoglycemia (Questions 11-13) Diabetes management during illness (Questions 14-16) Diabetes management at school (Questions 17-18) General health and care (Question 19) Prevention of chronic complications (Question 20) Responses can be marked as correct, incorrect, or left blank. Correct answers are scored 1 point, while blank or incorrect answers are scored 0 points. The total knowledge score is calculated out of 20 points.

  At baseline (5 minutes ago)

Study Arms (2)

Kamishibai Diabetes Education

EXPERIMENTAL

Patients in the intervention group will receive diabetes education using the Kamishibai method. This method involves interactive storytelling tailored to the cognitive and sensory development of children aged 8-12. Training will be conducted over 3 days, with 3 sessions each day. Patients will attend training daily without hospitalization. Training includes interactive storytelling using the Kamishibai method, designed to be engaging and suitable for children aged 8-12. After the training, participants will complete the Diabetes Knowledge Level Evaluation Form, the PedsQL 3.0 Quality of Life Scale, and the Kamishibai Training Feedback Form. Filling out the forms will take approximately 30 minutes. Follow-up information and checks will be provided every 3 months.

Other: kamishibai education

Routine diabetes education

EXPERIMENTAL

Patients in the control group will receive routine diabetes education as per standard hospital procedures. This training will also occur over 3 days, with 3 sessions per day. Training involves a PowerPoint presentation and a whiteboard, based on the Ministry of Health Childhood Diabetes Education guide. The language used will be simple and understandable for children. The training will be interactive, encouraging feedback and questions. Participants will fill out the Diabetes Knowledge Level Evaluation Form, PedsQL 3.0 Quality of Life Scale, and Routine Education Feedback Form after the training. Filling out the forms will take approximately 30 minutes. Follow-up information and checks will be provided every 3 months.

Other: routine education

Interventions

kamishibai education OTHER

Patients in the intervention group will be given Kamishibai diabetes education.

Kamishibai Diabetes Education

routine education OTHER

Patients in the control group will be given routine diabetes education.

Also known as: Patients in the intervention group will be given Kamishibai diabetes education.

Routine diabetes education

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The child is 8-12 years old.
• Diagnosed with Type 1 Diabetes Mellitus (T1DM) for at least 1 year.
• Followed up on an outpatient basis.
• The child is using insulin.
• The child can understand and speak Turkish.

You may not qualify if:

• Presence of another chronic disease other than T1DM that may affect glycemic control.
• Using an insulin pump.
• Having vision and/or hearing problems.
• Having a mental and/or neurological problem.
• Having a diagnosis of a psychiatric disease.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Work

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gülzade Uysal, Assoc.Dr.

  Sakarya University of Applied Sciences Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Makbule Yelda Karadere Rezaee, Msc.

CONTACT

+905541206527; yyeldakaradere@gmail.com

Gülzade Uysal, Assoc.Dr.

CONTACT

+905052520682; gulzadeuysal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diabetes Training Nurse

Model Details: Stratified randomized controlled trial

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: August 2, 2024
• Study Start: August 10, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)