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

NCT07095491 | Not Yet Recruiting

• 1 other identifier: Mersin_University
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Interventional

Keywords

Hemodialysis; Hybrid Education; Randomized Controlled Trial; Nursing

Outcome Measures

Primary Outcomes (3)

• Self-Care Self-Efficacy Scale

  Each item is rated on a 5-point Likert-type scale, ranging from 1 (not at all confident) to 5 (completely confident). The total score, consisting of four subscales and 10 items, ranges from 10 to 50. Higher scores indicate higher self-care and self-efficacy levels during treatment.

  Change from before implementation and 4th week of practice

• Haemodialysis Distress Thermometer Scale

  The scale includes a thermometer image, rated from 0 to 10. The participant indicates the overall level of distress they have felt over the past week on this scale. 0 = No distress at all, 10 = Unbearable distress. In the Turkish validation study, scores of 5 and above are generally considered clinical distress.

  Change from before implementation and 4th week of practice

• Hemodialysis Comfort Scale

  The scale, consisting of two subscales, is rated on a 5-point Likert-type scale (1 = never, 5 = always). The total score from the scale ranges from 9 to 45. Higher scores indicate a higher level of comfort for the individual.

  Change from before implementation and 4th week of practice

Study Arms (2)

Experimental group: Intervention: Education group

EXPERIMENTAL

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

Other: Experimental

Other: Control group

OTHER

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

Other: Control

Interventions

Experimental 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.

Experimental group: Intervention: Education group

Control OTHER

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

Other: Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Officials

• Esra Çavuşoğlu, Doctorate

  Mersin University

  STUDY DIRECTOR

• Esra Köse, Doctorate

  Mersin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esra Çavuşoğlu, Doctorate

CONTACT

+905344350790; esraopan00@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate, Research Assistant

Model Details: Prospective, parallel, two-arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share