Diet Therapy in Hemodialysis Patients

NCT ID: NCT06215339

Last Updated: 2024-01-22

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-07-01

Brief Summary

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This study determined the effect of dietary education given to hemodialysis patients on dietary treatment and symptoms.

Detailed Description

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Diet therapy is a part of the treatment of hemodialysis patients. In order for the treatment to be effective, it is necessary to comply with the diet. Non-compliance with diet treatment affects the symptoms experienced by the patient, resulting in morbidity, low quality of life and mortality. Knowing patients' compliance with diet therapy is important in ensuring symptom control. The aim of this study is to determine the effect of diet therapy on symptom management in hemodialysis patients.

Conditions

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Hemolysis Diet Symptoms and Signs Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

using G\*Power 3.1.9.2. The sample size was deemed sufficient (experiment=30; control=30), and the study was concluded. Participants were selected using a lottery method, and data were collected through a singleblind randomization process.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

While the patients were randomized; In order to keep the possibility of being affected by each other at a minimum level, the study was continued with the same application group in the same session group. For example; It's like working only with the robot cat group in the 08:00-12:00 session group on Mondays. In order to reduce the possibility of selection bias due to sample selection, "single-stage cluster type random sampling", which is a subtype of random sampling, was used. In addition, before the study, patients were informed about the study and their consent was obtained.

Study Groups

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group where diet education is given

Patients in the experimental group were given face-to-face diet education by the researcher in the waiting room for approximately 15 minutes and an "Information Brochure" was given.

Pre-training (pre-test) for hemodialysis patients Data collection tools were applied. All data collection tools were applied to these patients, except for the structured Patient Information Form for post-training measurements (intermediate measurement) 1 month after the training was given.

Group Type EXPERIMENTAL

diet therapy training

Intervention Type BEHAVIORAL

diet education

Control group

No treatment was performed on hemodialysis patients in this group. Only data collection forms were applied to the patients before the study (pretest), at the 1st week (intermediate measurement/1st measurement) and at the end of the study. (8th week) 3 times in total for 8 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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diet therapy training

diet education

Intervention Type BEHAVIORAL

Other Intervention Names

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Group without diet education

Eligibility Criteria

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Inclusion Criteria

Being ≥18 years old,

* Agreeing to participate in the research,
* Being literate,
* Being able to communicate verbally,
* Receiving outpatient HD treatment three sessions a week at the same institution,
* No impairment in mental and cognitive functions,
* Has been receiving HD treatment for at least three months (to be defined as a chronic HD program)

Exclusion Criteria

* Refusal to participate in the research,
* Being on peritoneal dialysis,
* Being diagnosed with a psychiatric disorder diagnosed by a psychiatrist,
* The general condition (hemodynamically) is unstable (heart rate \< 100 mm/Hg or diastolic BP\< 60 mm/Hg),
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dilan aktepe coşar

OTHER

Sponsor Role lead

Responsible Party

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Dilan aktepe coşar

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dilan aktepe coşar, lecture

Role: PRINCIPAL_INVESTIGATOR

Gümüşhane Universıty

Locations

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Gümüşhane Üniversitesi

Gümüşhane, Kelkit, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Hm20231001

Identifier Type: -

Identifier Source: org_study_id

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