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Clinical Trials/NCT07156942
NCT07156942CompletedNot Applicable

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

Afra ÇALIK2 sites in 1 country40 target enrollmentStarted: March 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Change in Treatment Adherence Score

Study Overview

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.

Study Design

Study Type
Interventional
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 Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
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

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

Arms & Interventions

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.

Intervention: Story-Based Digital Game (Behavioral)

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.

Outcomes

Primary Outcomes

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.

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

  • Change in Dietary Knowledge Score(Baseline, Week 2, Week 4)
  • Change in Anxiety Level(Baseline, Week 2, Week 4)

Investigators

Sponsor
Afra ÇALIK
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Afra ÇALIK

DR

Suleyman Demirel University

Study Sites (2)

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