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

Strategies to Strengthen Physical and Mental Health During Hemodialysis: Rhythm of Life

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07156942
Enrollment
40
Registered
2025-09-05
Start date
2025-03-01
Completion date
2025-04-30
Last updated
2025-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adherence, Anxiety, Game-Based Learning, Hemodialysis

Keywords

digital game, hemodialysis, adherence, anxiety, serious games

Brief 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.

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.

Sponsors

Afra ÇALIK
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Treatment Adherence ScoreBaseline, Week 2, Week 4Assessed using the End-Stage Renal Disease Adherence Questionnaire to measure adherence to dialysis schedules and treatment routines.

Secondary

MeasureTime frameDescription
Change in Dietary Knowledge ScoreBaseline, Week 2, Week 4Measured using the Hemodialysis Patients' Diet Knowledge Scale.
Change in Anxiety LevelBaseline, Week 2, Week 4Assessed using the State Anxiety Inventory (STAI-S) to measure perceived anxiety during treatment.

Other

MeasureTime frameDescription
Game Experience Score (GAMEX)Immediately after first game sessionEvaluated only in the intervention group using the Game Experience Questionnaire to assess enjoyment, absorption, and other psychological effects of gameplay.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026