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| ID | Type | Description | Link |
|---|---|---|---|
| Scientific Research Projects C | Other Identifier | Suleyman Demirel University |
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This clinical study is testing whether a short, story-based digital game played during dialysis can help improve the health and well-being of patients receiving hemodialysis. The researchers believe that using a digital game with an engaging storyline may help reduce anxiety, increase knowledge about healthy eating, and encourage patients to better follow their treatment plans.
The main hypothesis is that this interactive game will lead to lower anxiety levels, better understanding of dietary rules, and higher treatment adherence compared to standard care alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Story-Based Digital Game | Experimental | Participants in this arm received a short, story-based digital game intervention during their hemodialysis sessions. The game was played once per week for 4 weeks, with each session lasting approximately 10-15 minutes. The game aimed to reduce anxiety, improve treatment adherence, and increase dietary knowledge by engaging patients in interactive scenarios related to dialysis care. |
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| Standard Care | No Intervention | Participants in this arm received standard hemodialysis care without any additional digital game or educational intervention. They followed the usual treatment routines provided by the dialysis unit. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Story-Based Digital Game | Behavioral | Participants in this arm played a story-based digital game during their regular hemodialysis sessions. The game was administered once per week, with each session lasting approximately 10 to 15 minutes, over a 4-week period. The game was accessed via an online platform and designed to educate patients on dietary choices, fluid management, and dialysis self-care through interactive storytelling and decision-making tasks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Treatment Adherence Score | Assessed using the End-Stage Renal Disease Adherence Questionnaire to measure adherence to dialysis schedules and treatment routines. | Baseline, Week 2, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary Knowledge Score | Measured using the Hemodialysis Patients' Diet Knowledge Scale. | Baseline, Week 2, Week 4 |
| Change in Anxiety Level | Assessed using the State Anxiety Inventory (STAI-S) to measure perceived anxiety during treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Game Experience Score (GAMEX) | Evaluated only in the intervention group using the Game Experience Questionnaire to assess enjoyment, absorption, and other psychological effects of gameplay. | Immediately after first game session |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suleyman Demirel University | Isparta | Turkey (Türkiye) |
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| Label | URL |
|---|---|
| The full version of the game can be accessed online via the link | View source |
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Individual participant data (IPD) will not be shared because the study results are currently under consideration for publication, and data sharing may interfere with the peer-review and publication process.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2025 | Aug 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2025 | Aug 27, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2025 | Aug 27, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Only the outcomes assessor (biostatistician) was masked to group assignment. Participants, care providers, and investigators were aware of the assigned interventions. No additional parties were masked in this study.
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| Baseline, Week 2, Week 4 |