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

NCT07156942 | Completed

• 2 other identifiers: 9566Scientific Research Projects C
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Game-Based Learning; Adherence; Anxiety

Keywords

digital game; hemodialysis; adherence; anxiety; serious games

Outcome Measures

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.

  Baseline, Week 2, Week 4

Secondary Outcomes (2)

• Change in Dietary Knowledge Score

  Baseline, Week 2, Week 4

• Change in Anxiety Level

  Baseline, Week 2, Week 4

Other Outcomes (1)

• Game Experience Score (GAMEX)

  Immediately after first game session

Study Arms (2)

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.

Behavioral: Story-Based Digital Game

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.

Interventions

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.

Story-Based Digital Game

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Afra ÇALIK: lead

Study Sites (1)

Suleyman Demirel University

Isparta, Turkey (Türkiye)

Location

Related Links

• The full version of the game can be accessed online via the link

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: September 5, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: April 30, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)