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

June 10, 2026 updated by: Keziban Babadağ, Ege University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye), 35100
        • Ege University, Ataturk Vocational School of Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
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.
No Intervention: Control Group
This group receives standard routine care without any specific educational intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Day 45

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Pruritus-Related Quality of Life on the ItchyQoL Scale
Time Frame: 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.
Baseline and Day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

June 8, 2026

First Submitted That Met QC Criteria

June 10, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 10, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-8T/42; August 26, 2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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