Health Belief Model-Based Education for Pruritus and Quality of Life in Hemodialysis Patients

NCT07641530 | Completed

• 1 other identifier: 21-8T/42; August 26, 2021
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Pruritus

Keywords

Quality of Life; Patient Education; Health Belief Model

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change from Baseline in Pruritus-Related Quality of Life on the ItchyQoL Scale

  Baseline and Day 45

Study Arms (2)

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.

Behavioral: Health Belief Model-Based Education

Control Group

NO INTERVENTION

This group receives standard routine care without any specific educational intervention.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of antihistamines within the past month
• Conditions that could limit participation in the educational intervention

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, Ataturk Vocational School of Health Services

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the face-to-face nature of the educational intervention, blinding of the participants and the educator was not feasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PhD

Model Details: This is a cluster-randomized controlled trial where hemodialysis patients are allocated to the intervention and control groups based on treatment day clusters.

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 11, 2026
• Study Start: January 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)