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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control Group | No Intervention | This group receives standard routine care without any specific educational intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Belief Model-Based Education | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 45 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University, Ataturk Vocational School of Health Services | Izmir | 35100 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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This is a cluster-randomized controlled trial where hemodialysis patients are allocated to the intervention and control groups based on treatment day clusters.
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Due to the face-to-face nature of the educational intervention, blinding of the participants and the educator was not feasible.
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| D013568 | Pathological Conditions, Signs and Symptoms |