InterventionalNCT07095491

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

A study testing Experimental in people with Interventional, run by Mersin University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Interventional
What is being tested?: Experimental
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 2 sitesTurkey (Türkiye)
Study dates: 20 Jul 2025to 20 Oct 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

Mersin University Faculty of Nursing
Mersin, Yenişehir
Mersin University Hospital
Mersin

Other trials in Turkey (Türkiye)

About this study

Official 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

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).

Read the detailed description

The 104 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: Interventional
Being tested: Experimental, Control
Keywords: Hemodialysis, Hybrid Education, Randomized Controlled Trial, Nursing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07095491
Study group	Role	What they receive
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. Receives: 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). Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Change from before implementation and 4th week of practice

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 202520 Oct 2025

First posted31 Jul 2025
Study start20 Jul 2025
Primary completion20 Jul 2025
Study completion20 Oct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InterventionalStudies of the same condition, open and under way.
More trials run by Mersin UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, parallel, two-arm, randomized controlled clinical trial
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07095491
Sponsor's protocol ID: Mersin_University
Status last verified: Sep 2026
First submitted: 24 Jul 2025
Last updated: 2 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT07095491
Acronym / sponsor ID: Mersin_University
Conditions: Interventional
Keywords: Hemodialysis, Hybrid Education, Randomized Controlled Trial, Nursing
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Mersin UniversityUniversity, hospital or other
Study start: 20 Jul 2025 (actual)
Primary completion: 20 Jul 2025 (actual)
Study completion: 20 Oct 2025 (actual)
First posted: 31 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Prospective, parallel, two-arm, randomized controlled clinical trial

Arm	Type	Receives
Experimental group: Intervention: Education group	Experimental	Other: ExperimentalA structured hybrid training program based on self-care and self-efficacy will be implemented for the intervention group.
Other: Control group	Other	Other: ControlThe control group will not receive any different intervention and will continue the process with routine nursing care (standard treatment).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ExperimentalA 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	Experimental group: Intervention: Education group
ControlThe control group will not receive any different intervention and will continue the process with routine nursing care (standard treatment).	Other	Other: Control group

Primary outcome

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.
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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Esra Çavuşoğlu, Doctorate study director

Mersin University

Esra Köse, Doctorate principal investigator

Mersin University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental in people with Interventional, run by Mersin University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-Care Self-Efficacy Scale (time frame: Change from before implementation and 4th week of practice). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07095491.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.