Hemodialysis, Pruritus
Conditions
Keywords
Quality of Life, Patient Education, Health Belief Model
Brief 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. 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.
Interventions
BEHAVIORALHealth Belief Model-Based Education
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.
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Due to the face-to-face nature of the educational intervention, blinding of the participants and the educator was not feasible.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Use of antihistamines within the past month * Conditions that could limit participation in the educational intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pruritus Severity on the 5-D Itch Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pruritus-Related Quality of Life on the ItchyQoL Scale | Baseline and Day 45 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed