Strategies to Strengthen Physical and Mental Health During Hemodialysis: Rhythm of Life
Phase: NA
Conditions: Hemodialysis, Game-Based Learning, Adherence, Anxiety
Sponsor: Afra ÇALIK

Study Protocol 
Official Title: A Story-Based Digital Game to Reduce Anxiety and Improve Treatment 
Compliance in Hemodialysis Patients: A Randomized Controlled Trial 
NCT Number: To be assigned 
Ethics Committee Approval Number: E.888577 
 
Study Period: March 2025 – April 2025 
 
 

Study Protocol 
Title: A Story-Based Digital Game to Reduce Anxiety and Improve Treatment Compliance in 
Hemodialysis Patients 
Protocol Version: 1.0 
Protocol Date: March 1, 2025 
Principal Investigator(s): Dr. Afra Çalık, Assoc. Prof. Sıddıka Ersoy 
Institution: Suleyman Demirel University, Department of Nursing 
Sponsor: Suleyman Demirel University BAP Coordination Unit 
1. Project and Study Dates 
Project Duration (BAP-Funded): January 3, 2025 – June 17, 2025 
Study Implementation Dates: March 1, 2025 – April 30, 2025 
2. Ethical Approval 
The study protocol was reviewed and approved by the Ethics Committee of Suleyman Demirel 
Ethics Approval Number: E.888577 
Ethics Approval Date: 11.15.2024 
3. Background and Rationale 
Hemodialysis patients often face psychological stress, low adherence, and dietary 
mismanagement. This study introduces a story-based digital game to educate and emotionally 
support patients during dialysis sessions. 
4. Objectives 
- To evaluate the impact of a digital game on treatment adherence 
- To assess improvements in dietary knowledge 
- To determine reductions in anxiety levels among participants 
5. Study Design 
This is a single-center, single-blinded randomized controlled trial. Participants are assigned to 
either the intervention (digital game) group or control (standard care) group. Sessions were 
separated to prevent contamination, and the statistician was blinded to group assignment. 
6. Study Population 
Inclusion Criteria: 
- Age 18–80 years 
- At least 6 months on hemodialysis 
- Literate 
- Consent provided 
 

Exclusion Criteria: 
- Cognitive impairment or refusal to consent 
7. Intervention Description 
The digital game features a fictional character beginning dialysis. Patients mentor this character 
through challenges, reinforcing their own knowledge on diet, fluid management, and self-care. 
Each session lasts 10–15 minutes. 
8. Outcome Measures 
Primary: 
- End-Stage Renal Disease Adherence Scale 
- Hemodialysis Patients’ Diet Knowledge Scale 
- State Anxiety Scale 
 
Secondary: 
- Game Experience Questionnaire (GAMEX) 
9. Statistical Analysis 
Data will be analyzed per the Statistical Analysis Plan (SAP). Non-parametric methods (Mann–
Whitney U, Friedman test) and Bonferroni-corrected Wilcoxon tests will be used. SPSS v26.0 
will be employed. 
10. Informed Consent and Confidentiality 
Informed consent will be obtained from all participants prior to enrollment. Participant 
confidentiality will be ensured. All data will be anonymized. 
11. Monitoring and Reporting 
Adverse events will be monitored throughout the study. All protocol deviations and issues will be 
documented and reported.