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CompletedNCT07156942Updated Sep 5, 2025

A Story-Based Game to Reduce Anxiety and Improve Compliance in Hemodialysis Patients: RCT

An interventional study of Story-Based Digital Game in Hemodialysis, Game-Based Learning and Adherence, sponsored by Afra ÇALIK. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Afra ÇALIK · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

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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Conditions studied

  • Hemodialysis
  • Game-Based Learning
  • Adherence
  • Anxiety

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Keywords

  • digital game
  • hemodialysis
  • adherence
  • anxiety
  • serious games
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

This is the only study on the registry with Afra ÇALIK as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults aged between 18 and 80 years
  • Receiving regular hemodialysis treatment for at least 6 months
  • Oriented to time, place, and person
  • Minimum primary school education
  • Able and willing to provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate in the study
  • Inability to provide informed consent due to cognitive or communication difficulties
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Story-Based Digital Game

    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.

    Behavioral: Story-Based Digital Game

  • No intervention
    Standard Care

    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.

Interventions

  • BehavioralStory-Based Digital Game

    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.

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What researchers measure

Primary outcomes

  1. Change in Treatment Adherence Score

    Assessed using the End-Stage Renal Disease Adherence Questionnaire to measure adherence to dialysis schedules and treatment routines.

    Time frame: Baseline, Week 2, Week 4

Secondary outcomes

  1. Change in Dietary Knowledge Score

    Measured using the Hemodialysis Patients' Diet Knowledge Scale.

    Time frame: Baseline, Week 2, Week 4

  2. Change in Anxiety Level

    Assessed using the State Anxiety Inventory (STAI-S) to measure perceived anxiety during treatment.

    Time frame: Baseline, Week 2, Week 4

Other outcomes

  1. 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.

    Time frame: Immediately after first game session

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Study locations

1 site
  • Suleyman Demirel University
    Isparta, Turkey (Türkiye)
08

References and documents

Study documents

  • Study protocol · Mar 1, 2025
  • Statistical analysis plan · Mar 1, 2025
  • Informed consent form · Mar 1, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07156942
Lead sponsor
Afra ÇALIK
Responsible party
Afra ÇALIK (DR, Suleyman Demirel University) — Sponsor-investigator
First posted
Sep 5, 2025
Start date
Mar 1, 2025
Primary completion
Mar 1, 2025
Completion
Apr 30, 2025
Last update
Sep 5, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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