HemodialysisNCT07641530
Health Belief Model-Based Education for Pruritus and Quality of Life in Hemodialysis Patients
A study testing Health Belief Model-Based Education in people with Hemodialysis and Pruritus, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the effect of a Health Belief Model (HBM)-based educational intervention on pruritus severity and pruritus-related quality of life (QoL) in hemodialysis patients. The cluster-randomized controlled trial includes hemodialysis patients allocated to an intervention group and a control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Pruritus
- What is being tested?
- Health Belief Model-Based Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Diagnosed with end-stage renal disease requiring maintenance hemodialysis for at least 3 months
- Experienced CKD-associated pruritus during the previous 2 weeks
Who cannot join
- Use of antihistamines within the past month
- Conditions that could limit participation in the educational intervention
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, Ataturk Vocational School of Health Services
Izmir, 35100
About this study
Official title: The Effect of Education Given Based on Health Belief Model on Itch Symptom Management and Quality of Life in Hemodialysis Patients
This study evaluates the effect of a Health Belief Model (HBM)-based educational intervention on pruritus severity and pruritus-related quality of life (QoL) in hemodialysis patients. The cluster-randomized controlled trial includes hemodialysis patients allocated to an intervention group and a control group. The intervention group receives two face-to-face HBM-based education sessions at 15-day intervals supported by a structured booklet, while the control group receives standard care. Pruritus outcomes and quality of life are assessed using the 5-D Itch Scale and ItchyQoL to determine the effectiveness of theory-driven educational frameworks in routine nursing care and patient-centered outcomes.
- Conditions
- Hemodialysis, Pruritus
- Being tested
- Health Belief Model-Based Education
- Keywords
- Quality of Life, Patient Education, Health Belief Model
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model-Based EducationBehavioural
The intervention consists of a theory-based educational program focused on chronic kidney disease-associated pruritus symptom management, structured according to the Health Belief Model (HBM). Patients receive two face-to-face education sessions conducted at 15-day intervals, supported by a structured educational booklet. Data collection is performed twice, at baseline and on day 45, using a descriptive information form, the 5-D Itch Scale, and the ItchyQoL scale.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group receives two face-to-face Health Belief Model (HBM)-based education sessions at 15-day intervals supported by a structured booklet. Receives: Behavioral: Health Belief Model-Based Education |
| Control Group | No intervention | This group receives standard routine care without any specific educational intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pruritus Severity on the 5-D Itch Scale
The 5-D Itch Scale is used to measure the multidimensional aspects of pruritus (duration, degree, direction, disability, and distribution). Total scores range from 5 (no itch) to 25 (most severe itch), where higher scores indicate greater pruritus severity.
Measured: Baseline and Day 45
Secondary outcomes (1)
Change from Baseline in Pruritus-Related Quality of Life on the ItchyQoL Scale
The ItchyQoL scale is a disease-specific instrument used to assess the quality of life in patients with pruritus across symptoms, functioning, and emotions domains. Total scores range from 22 to 110, where higher scores indicate greater impairment in pruritus-related quality of life.
Measured: Baseline and Day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Ege 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster-randomized controlled trial where hemodialysis patients are allocated to the intervention and control groups based on treatment day clusters.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keziban Babadağ, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641530
- Sponsor's protocol ID
- 21-8T/42; August 26, 2021
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given Based on Health Belief Model on Itch Symptom Management and Quality of Life in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07641530
- Acronym / sponsor ID
- 21-8T/42; August 26, 2021
- Conditions
- Hemodialysis, Pruritus
- Keywords
- Quality of Life, Patient Education, Health Belief Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 11 Jun 2026 (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.
This study evaluates the effect of a Health Belief Model (HBM)-based educational intervention on pruritus severity and pruritus-related quality of life (QoL) in hemodialysis patients. The cluster-randomized controlled trial includes hemodialysis patients allocated to an intervention group and a control group. The intervention group receives two face-to-face HBM-based education sessions at 15-day intervals supported by a structured booklet, while the control group receives standard care. Pruritus outcomes and quality of life are assessed using the 5-D Itch Scale and ItchyQoL to determine the effectiveness of theory-driven educational frameworks in routine nursing care and patient-centered outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster-randomized controlled trial where hemodialysis patients are allocated to the intervention and control groups based on treatment day clusters.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Health Belief Model-Based EducationThis group receives two face-to-face Health Belief Model (HBM)-based education sessions at 15-day intervals supported by a structured booklet. |
| Control Group | No intervention | –This group receives standard routine care without any specific educational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Diagnosed with end-stage renal disease requiring maintenance hemodialysis for at least 3 months
- Experienced CKD-associated pruritus during the previous 2 weeks
Key exclusion criteria (2 listed)
- Use of antihistamines within the past month
- Conditions that could limit participation in the educational intervention
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 |
|---|---|---|
| Health Belief Model-Based EducationThe intervention consists of a theory-based educational program focused on chronic kidney disease-associated pruritus symptom management, structured according to the Health Belief Model (HBM). Patients receive two face-to-face education sessions conducted at 15-day intervals, supported by a structured educational booklet. Data collection is performed twice, at baseline and on day 45, using a descriptive information form, the 5-D Itch Scale, and the ItchyQoL scale. | Behavioural | Intervention Group |
Primary outcome
Change from Baseline in Pruritus Severity on the 5-D Itch Scale
Time frame: Baseline and Day 45
The 5-D Itch Scale is used to measure the multidimensional aspects of pruritus (duration, degree, direction, disability, and distribution). Total scores range from 5 (no itch) to 25 (most severe itch), where higher scores indicate greater pruritus severity.
1 secondary outcome
Change from Baseline in Pruritus-Related Quality of Life on the ItchyQoL Scale
Time frame: Baseline and Day 45
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 11 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Belief Model-Based Education in people with Hemodialysis and Pruritus, run by Ege University at 1 site 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 3 inclusion and 2 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from Baseline in Pruritus Severity on the 5-D Itch Scale (time frame: Baseline and Day 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.