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临床试验/NCT07030361
NCT07030361已完成不适用

Innovative Dialaysis Suit for Hemodialysis Patients Effect of Fluid Restriction on Compliance and Level of Empowerment: Randomise Controlled Trials

Balikesir University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年2月22日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
2
主要终点
intradialytic fluid balance

研究概览

简要总结

The aim of this observational study is to determine the effect of a dialysis gown designed according to the empowerment model on changes in weight control behaviors among gown group patients during the intradialytic period. The main question it seeks to answer is:

• Is the dialysis gown effective in helping gown group patients control their fluid intake during the intradialytic period?

详细描述

In this study, researchers designed a study to compare whether the behavior of controlling excessive fluid intake during the intradialytic period was better in the group of patients wearing dialysis garments designed according to the empowerment model than in the education and control groups. For this randomized controlled study, patients were divided into three groups. The patients were named the garment group, the education group, and the control group. In the study design, patients underwent garment application and education application. In the garment application, the amount of excess fluid removed by ultrafiltration during that dialysis session was placed in the pockets of the serum dialysis garment, and patients were asked to walk in a 10-meter walking test area. In the education application, a video-based education program designed to teach fluid compliance behavior was implemented. Patients were asked to watch this video education program for an average of half an hour at the beginning of each session.

Patients in the garment group were dressed in dialysis garments and shown the educational video. Patients in the education group were only shown the fluid compliance video. No intervention specific to the study was performed on patients in the control group. All patients continued to receive the normal follow-up and care protocol required for hemodialysis treatment.

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 (Participant)

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

入选标准

  • Turkish-speaking
  • Turkish-understanding
  • Older than 18 years of age
  • Without communication barriers such as visual and hearing impairment
  • Non-hypotensive and non-anemic patients
  • With an intradialytic weight of 2-5 liters
  • Receiving hemodialysis treatment for more than three months and outpatients

排除标准

  • Patients who had previously received fluid restriction compliance training
  • Who refused to participate in the study
  • Who had undergone surgery within the last six weeks

结局指标

主要结局

intradialytic fluid balance

时间窗: 8 weeks

weight gained during the intradialytic period

次要结局

未报告次要终点

研究者

发起方
Balikesir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Türkan Çalışkan

asist proff

Balikesir University

研究点 (2)

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