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NCT Number: NCT07095491

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control

Other

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

Primary outcomes

  1. Self-Care Self-Efficacy Scale

    Time frame: Change from before implementation and 4th week of practice

    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.

  2. Haemodialysis Distress Thermometer Scale

    Time frame: Change from before implementation and 4th week of practice

    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.

  3. Hemodialysis Comfort Scale

    Time frame: Change from before implementation and 4th week of practice

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esra Çavuşoğlu, Doctorate

CONTACT

[email protected]

+905344350790 ext. 14237

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

Multidimensional Effectiveness of Self-care and Self-efficacy Based Hybrid Education in Hemodialysis Patients: A Randomised Controlled Trial on Clinical, Psychosocial and Comfort Aspects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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