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临床试验/NCT07156942
NCT07156942已完成不适用

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

Afra ÇALIK2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Change in Treatment Adherence Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: 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.

结局指标

主要结局

Change in Treatment Adherence Score

时间窗: 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

时间窗: Baseline, Week 2, Week 4

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

次要结局

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

研究者

发起方
Afra ÇALIK
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Afra ÇALIK

DR

Suleyman Demirel University

研究点 (2)

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