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

NCT ID: NCT07156942

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemodialysis Game-Based Learning Adherence Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Story-Based Digital Game

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Story-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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Afra ÇALIK

OTHER

Sponsor Role lead

Responsible Party

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Afra ÇALIK

DR

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Suleyman Demirel University

Isparta, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://view.genially.com/67b70f2c70b12069df602e8b/interactive-content-basla

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

Other Identifiers

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Scientific Research Projects C

Identifier Type: OTHER

Identifier Source: secondary_id

9566

Identifier Type: -

Identifier Source: org_study_id

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