Intradıalytıc Weıght Control In Hemodıalysıs Patıents

NCT ID: NCT07030361

Last Updated: 2025-06-22

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2023-09-30

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Fluid Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Research data were collected in 3 stages: pretest (Z0), posttest (Z1) and follow-up test (Z2).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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suits group

Dialysis suit group was dressed in dialysis suit and given fluid control training

Group Type ACTIVE_COMPARATOR

suit group

Intervention Type BEHAVIORAL

elbise giydirme ve video izletme uygulaması

2 training group

Fluid control training was given to the traininig group

Group Type PLACEBO_COMPARATOR

training group

Intervention Type BEHAVIORAL

video izletme uygulaması

control group

Control group received no intervention, clinical care

Group Type OTHER

control group

Intervention Type BEHAVIORAL

rutin hemş bakımı uygulaması, herhangi bir müdahale yok

Interventions

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suit group

elbise giydirme ve video izletme uygulaması

Intervention Type BEHAVIORAL

training group

video izletme uygulaması

Intervention Type BEHAVIORAL

control group

rutin hemş bakımı uygulaması, herhangi bir müdahale yok

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balikesir University

OTHER

Sponsor Role lead

Responsible Party

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Türkan Çalışkan

asist proff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alper Azak, Asist Prof

Role: PRINCIPAL_INVESTIGATOR

balikesir

Locations

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Balikesir University

Balıkesir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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Other Identifiers

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222S306

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BalikesirUniversity HealtScien

Identifier Type: -

Identifier Source: org_study_id

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