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OpenTrials
Completed

NCT Number: NCT07156942

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

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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Key information

Conditions

Hemodialysis Adherence Anxiety Anxiety Disorders Game-Based Learning Mental Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suleyman Demirel University

Isparta, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Treatment Adherence Score

    Time frame: Baseline, Week 2, Week 4

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

Secondary outcomes

  1. Change in Dietary Knowledge Score

    Time frame: Baseline, Week 2, Week 4

    Measured using the Hemodialysis Patients' Diet Knowledge Scale.

  2. Change in Anxiety Level

    Time frame: Baseline, Week 2, Week 4

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

Other outcomes

  1. Game Experience Score (GAMEX)

    Time frame: Immediately after first game session

    Evaluated only in the intervention group using the Game Experience Questionnaire to assess enjoyment, absorption, and other psychological effects of gameplay.

Sponsors and collaborators

Lead sponsor

Afra ÇALIK

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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