Intradıalytıc Weıght Control In Hemodıalysıs Patıents (DialysisSuit)

June 12, 2025 updated by: Türkan Çalışkan, Balikesir University

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Balikesir, Turkey, 10145
        • Balikesir University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: suits group
Dialysis suit group was dressed in dialysis suit and given fluid control training
Behavioral: suit group
elbise giydirme ve video izletme uygulaması
Placebo Comparator: 2 training group
Fluid control training was given to the traininig group
Behavioral: training group
video izletme uygulaması
Other: control group
Control group received no intervention, clinical care
Behavioral: control group
rutin hemş bakımı uygulaması, herhangi bir müdahale yok

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intradialytic fluid balance
Time Frame: 8 weeks
weight gained during the intradialytic period
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balikesir University

Investigators

  • Principal Investigator: Alper Azak, Asist Prof, balikesir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Actual)

July 5, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

June 12, 2025

First Posted (Actual)

June 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 22, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BalikesirUniversity HealtScien
  • 222S306 (Other Grant/Funding Number: TÜBİTAK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

the product used in the research has not yet entered the production phaset

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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