Clinical, Psychosocial, and Comfort Effects of Hybrid Education in Hemodialysis Patients: A Randomized Controlled Trial

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-11-30

Brief Summary

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The purpose of this study is to evaluate the impact of a self-care and self-efficacy-based hybrid education program implemented for individuals receiving hemodialysis treatment on their clinical findings, psychosocial status (dialysis distress), and comfort levels during the dialysis process.

For this purpose, the most important questions to be answered in the study are as follows:

* What are the clinical findings, psychosocial status (dialysis distress), and comfort levels of hemodialysis patients at the beginning of the study?
* Does the self-care and self-efficacy-based hybrid education have an impact on the clinical findings, psychosocial status (dialysis distress), and comfort levels of hemodialysis patients?

Participants:

The intervention group will receive a structured hybrid education program based on self-care and self-efficacy. The control group will not receive any intervention during this period and will continue with routine nursing care (standard treatment).

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Detailed Description

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The 78 hemodialysis patients included in the study will initially be administered a personal information form, a self-care/self-efficacy scale, a hemodialysis distress thermometer, and a hemodialysis comfort scale. The intervention group will then receive a structured hybrid training program focused on self-care and self-efficacy. The training will be conducted in two sessions, one day per week, over a total of two weeks.

The training process is designed as a hybrid, incorporating both in-person and online sessions. The training will be supported by interactive sessions, practical demonstrations, guidance materials, and reminder/motivational messages sent via WhatsApp to improve individuals' self-care behaviors, psychological resilience, comfort levels, and clinical parameters.

The control group will not receive any intervention during this period and will continue with routine nursing care (standard treatment). Both groups will be assessed twice, before the training and four weeks after the training, using the relevant data collection form.

Conditions

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Interventional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, two-arm, randomized controlled clinical trial

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Since hemodialysis patients participating in the study will be in either the training (experimental) or control groups, blinding will not be possible. Researchers will be blinded only during group assignment (groups A and B). Data will be transferred to a computer by the researchers, and a biostatistician independent of the study will analyze the data and report the findings, without knowing which groups A and B are assigned. This will ensure the biostatistician is blinded.

Study Groups

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Experimental group: Intervention: Education group

A structured hybrid training program based on self-care and self-efficacy will be implemented for the intervention group.

Group Type EXPERIMENTAL

Experimental

Intervention Type OTHER

A structured hybrid training program based on self-care and self-efficacy will be implemented for the intervention group. The training will be conducted in two sessions, one day per week, over a total of two weeks.

Other: Control group

The control group will not receive any different intervention and will continue the process with routine nursing care (standard treatment).

Group Type OTHER

Control

Intervention Type OTHER

The control group will not receive any different intervention and will continue the process with routine nursing care (standard treatment).

Interventions

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Experimental

A structured hybrid training program based on self-care and self-efficacy will be implemented for the intervention group. The training will be conducted in two sessions, one day per week, over a total of two weeks.

Intervention Type OTHER

Control

The control group will not receive any different intervention and will continue the process with routine nursing care (standard treatment).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 18 and over
* Patients who have been receiving hemodialysis treatment for at least 6 months
* Those with stable clinical findings
* Those who have not previously received professional training in self-care and self-sufficiency
* Those who have the cognitive ability to complete the data collection form
* Those who do not have a severe visual or auditory impairment
* Those who can use a smartphone and have access to the WhatsApp application
* Those who volunteer to participate in the study and sign the Informed Consent Form will be included.

Exclusion Criteria

* Under 18 years of age
* Patients receiving hemodialysis treatment for less than 6 months
* Those whose clinical findings fluctuate to the point of being life-threatening
* Those who have previously received professional training on self-care and self-sufficiency
* Individuals who declare that they will not be able to attend at least one of the training sessions during the program
* Individuals who are simultaneously participating in another training program or psychosocial intervention
* Those who do not have the cognitive capacity to complete the data collection form
* Individuals who cannot effectively participate in the applications due to visual or hearing impairments
* Individuals who cannot use a smartphone or do not have access to the WhatsApp application
* Those who do not wish to participate in the study and who do not sign the Informed Consent Form will not be included.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes