The Effect of Game-based Education on Adherence to Treatment and Anxiety Level in Type 2 Diabetics Started on Insulin Therapy
Phase: NA
Conditions: Type 2 Diabetes, Diabete Mellitus
Sponsor: Izmir Tinaztepe University

STUDY PROTOCOL 
 
Official Title: The Effect of Game-Based Education on Treatment Adherence and Anxiety 
Levels in Type 2 Diabetic Patients Initiated on Insulin Therapy 
 
NCT ID: Not Yet Assigned 
 
Unique Protocol ID: 352-352-10 
 
Document Date: September 25, 2025 
 
Sponsor / Responsible Party: Tınaztepe University   
Principal Investigator: Assist. Prof. Gönül Düzgün 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1. STUDY SUMMARY 
Background 
Diabetes mellitus, especially Type 2 Diabetes Mellitus (T2DM), is a growing public health 
problem worldwide. Individuals newly initiated on insulin therapy often experience 
increased anxiety and decreased treatment adherence. Game-based educational 
methods have been shown to improve motivation, reduce anxiety, and enhance 
learning. This study evaluates the effect of a specially designed board game, "Let's Learn 
Diabetes," on treatment adherence and anxiety levels. 
 Objective 
To determine whether game-based education improves treatment adherence and 
reduces anxiety levels in patients with Type 2 Diabetes who have recently started insulin 
therapy. 
Hypotheses 
- H1: Game-based diabetes education will significantly improve treatment adherence 
levels. 
- H2: Game-based diabetes education will significantly reduce anxiety levels. 
2. STUDY DESIGN 
This is a randomized controlled trial (RCT) with pre-test and post-test measures. 
- Groups:Intervention group (game-based education) and Control group (traditional 
education). 
- Duration:1 month of active intervention followed by a 1-month follow-up. 
- Randomization:Participants will be randomly assigned to either the intervention or 
control group. 
3. STUDY POPULATION 
Inclusion Criteria: 
- Age between 40-65 years. 
- Diagnosed with Type 2 Diabetes for at least 1 year. 
- Initiated insulin therapy within the last 3 months. 
- No diagnosed mental health disorders. 
- Voluntary participation with signed informed consent. 

 
Exclusion Criteria: 
- Age below 40 or above 65 years. 
- On insulin therapy for more than 3 months. 
- Mental or psychological comorbidities. 
- Declining to participate or incomplete participation in all four sessions. 
Study Site 
Uşak Training and Research Hospital Diabetes Education Unit and Diabetes School. 
4. SAMPLE SIZE 
The sample size was calculated using G*Power 3.1.9.2 at a 95% confidence level, effect 
size 0.768, and power of 85%.  
- Minimum required per group: 32 participants 
- Total sample size: 72 participants (36 in each group) 
5. STUDY PROCEDURES 
Intervention Group: 
- Participants will attend four 2-hour game-based education sessions, once per week for 
1 month. 
- Game sessions will be conducted using the "Let's Learn Diabetes" board game, which 
includes three difficulty levels. 
Control Group: 
- Participants will receive traditional diabetes education through lectures and 
presentations for the same duration. 
Follow-up: 
- Post-test measurements will be collected one month after completion of the 
intervention. 
6. OUTCOME MEASURES 
Primary Outcomes: 
1. Anxiety level measured by Beck Anxiety Scale (BAS). 
2. Treatment adherence measured by the Patient Compliance Scale for Type 2 Diabetes 
Mellitus Treatment. 

 
Secondary Outcomes: 
- Sub-dimension scores of the treatment adherence scale, including emotional factors, 
knowledge factors, lifestyle changes, and diet-related factors. 
 
7. DATA COLLECTION 
Data will be collected at two time points: 
Pre-test: Before the first intervention session. 
Post-test: After the final session. 
Instruments: 
- Beck Anxiety Scale (BAS) 
- Patient Compliance Scale for Type 2 Diabetes Mellitus Treatment 
8. STATISTICAL ANALYSIS 
- Statistical analyses will be conducted using SPSS version 25.0. 
- Descriptive statistics: mean, standard deviation, frequency, and percentage. 
- Independent t-tests will be used for between-group comparisons. 
- Paired t-tests for within-group comparisons. 
- Pearson correlation for relationships between anxiety and adherence. 
- Significance level set at p<0.05. 
- Cronbach's alpha will be used to assess the reliability of scales. 
9. ETHICS 
The study complies with the Declaration of Helsinki. Ethical approval was obtained from 
the Uşak University Non-Interventional Clinical Research Ethics Committee (Decision 
Number: 352-352-10). Written informed consent will be obtained from all participants. 
10. STUDY TIMELINE 
- Recruitment: May 2024 - October 2024 
- Intervention: October 2024 
- Data Collection: November 2024 
- Analysis and Reporting: December 2024 - March 2025 

INFORMED CONSENT FORM 
 
 Official Title:  The Effect of Game-Based Education on Treatment Adherence and Anxiety Levels in 
Type 2 Diabetic Patients Initiated on Insulin Therapy  
 NCT ID:  Not Yet Assigned  
 Unique Protocol ID:  352-352-10  
 Document Date:  September 25, 2025  
 Sponsor / Responsible Party:  Tınaztepe University  
 Principal Investigator:  Assist. Prof. Gönül Düzgün 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Dear Volunteer / Legal Representative, 
 
You are invited to participate in a study conducted to evaluate the effect of game-based education 
on treatment adherence and anxiety levels in individuals with Type 2 Diabetes Mellitus who have 
recently started insulin therapy. Before you decide to participate, it is important that you understand 
the purpose of the study, the procedures involved, potential benefits, and any possible risks or 
discomforts. Please read this form carefully and feel free to ask questions. 
Participation is  completely voluntary . You may refuse to participate or withdraw from the study at 
any time without any penalty or loss of benefits. 
  Purpose of the Study 
The aim of this study is to examine whether a specially designed game-based education program 
called  "Let's Learn Diabetes"  can improve treatment adherence and reduce anxiety levels among 
Type 2 Diabetes patients who are newly initiated on insulin therapy. 
  Study Procedures 
- The study will take place at the  Uşak Training and Research Hospital Diabetes Education Unit and 
Diabetes School . 
- Participants will attend  four educational sessions , once per week, each lasting approximately  two 
hours . 
- The intervention group will participate in interactive game-based sessions, while the control group 
will receive standard education through lectures. 
- Follow-up measurements will be conducted one month after the final session. 
 Potential Risks and Discomforts 
This study involves only educational interventions. There are  no known physical or psychological 
risks  associated with participation. 
  Potential Benefits 
- Participation may improve your diabetes self-management skills and reduce anxiety. 
- On a societal level, this research may contribute to the development of innovative educational 
strategies that reduce diabetes-related healthcare costs. 
 Confidentiality 
Your personal information will remain confidential. All data will be coded and anonymized. In any 
publication or presentation, your identity will  not be disclosed 
   Rights Regarding Participation 

- Your participation is entirely voluntary. 
- You may withdraw at any time without affecting your medical care or legal rights. 
- If new findings arise during the study that may influence your decision to continue, you will be 
informed promptly. 
   Contact Information 
For questions or to report any issues, you may contact the research team 24/7: 
-  Diabetes Education Nurse:  Esin Erdem – +90 505 624 8353 
-  Principal Investigator:  Assist. Prof. Gönül Düzgün – +90 544 779 35 97 
   Consent and Signatures 
By signing below, you acknowledge that you have read and understood the information provided, 
had the opportunity to ask questions, and voluntarily agree to participate in this study. 
 
| Role   
 
| Name & Surname | Signature  
| Date | 
|-----------------------------|--------------------------|-------------------------|------| 
| Volunteer / Legal Representative  
| Researcher (Diabetes Nurse)  
| Witness  
 Ethics Approval:  This study was approved by the Uşak University Non-Interventional Clinical 
Research Ethics Committee (Decision Number: 352-352-10). 
 

STATİSTİCAL ANALYSİS PLAN 
 
STATISTICAL ANALYSIS PLAN (SAP) 
- Intention-to-Treat (ITT): Includes all randomized participants who completed at least one 
session. 
- Per-Protocol (PP): Includes only participants who completed all four sessions. 
 DATA MANAGEMENT 
- Data will be entered and stored securely with anonymized participant IDs. 
- Data quality checks will be performed to identify inconsistencies or missing data. 
- Missing data will be handled using listwise deletion for final analyses. 
STATISTICAL SOFTWARE 
All analyses will be conducted using **SPSS version 25.0**. 
DESCRIPTIVE ANALYSIS 
- Continuous variables: Mean ± Standard Deviation (SD), Minimum, Maximum. 
- Categorical variables: Frequencies and Percentages. 
STATISTICAL METHODS 
Baseline Comparisons 
- Independent samples t-test for continuous baseline characteristics (e.g., age, baseline 
anxiety). 
- Chi-square test for categorical variables (e.g., gender, marital status). 
Primary Outcome Analyses 
- Within-group analysis: Paired t-test comparing pre-test and post-test scores for anxiety and 
adherence. 
- Between-group analysis: Independent t-test comparing post-test mean differences between 
intervention and control groups. 
Secondary Outcome Analyses 
- Pearson correlation to examine relationships between anxiety levels and sub-dimensions of 
treatment adherence. 
- Subgroup analyses by demographic factors (age, gender, education level). 
 
Reliability Testing 

- Cronbach’s alpha will be calculated for all scales to ensure internal consistency (>0.70 
acceptable). 
NORMALITY AND ASSUMPTIONS 
- Normality will be assessed using Kurtosis and Skewness statistics. 
- Homogeneity of variances will be checked using Levene's test. 
- If assumptions are violated, non-parametric equivalents (Mann-Whitney U test, Wilcoxon 
Signed-Rank test) will be applied. 
SIGNIFICANCE LEVEL 
- All statistical tests will be two-tailed, with a significance threshold of p < 0.05. 
 HANDLING DROPOUTS 
- Participants who miss one or more intervention sessions will be excluded from the Per-
Protocol analysis but included in the Intention-to-Treat analysis if they completed pre-test 
measurements. 
REPORTING 
- Results will be presented in tables and graphs with exact p-values, 95% confidence intervals, 
and effect sizes where appropriate. 
- CONSORT flow diagram will be included to demonstrate participant flow. 
ETHICAL CONSIDERATIONS 
The study was approved by the Uşak University Non-Interventional Clinical Research Ethics 
Committee (Decision Number: 352-352-10). Data privacy will be strictly maintained 
following the Declaration of Helsinki. 
TIMELINE FOR ANALYSIS 
- Data Cleaning and Preparation: November 2024 
- Statistical Analysis: December 2024 
- Final Reporting: January - March 2025