Skip to main content
OpenTrials
Completed

NCT Number: NCT07641530

Health Belief Model-Based Education for Pruritus 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemodialysis Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University, Ataturk Vocational School of Health Services

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

The Effect of Education Given Based on Health Belief Model on Itch Symptom Management and Quality of Life in Hemodialysis Patients

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.