NURSE-LED PATİENT EDUCATİON İN ESWL PATİENTS (ESWL-VAS-STAI)

May 21, 2026 updated by: Cemile Nida Kayış, KTO Karatay University

THE EFFECT OF NURSE-LED STRUCTURED PATİENT EDUCATİON ON ANXİETY AND QUALİTY OF LİFE İN PATİENTS UNDERGOİNG EXTRACORPOREAL SHOCK WAVE LİTHOTRİPSY: A RANDOMİZED CONTROLLED TRİAL

Urolithiasis is a significant health problem characterized by the formation of stones in urinary system organs such as the kidneys, ureters, and bladder, and its prevalence is increasing worldwide. It is reported that its prevalence varies between 1% and 20% due to geographical, diet-related, genetic, and climatic factors, and it shows a recurrence rate of approximately 50%. Urolithiasis is the third most common pathology in urology after urinary tract infections and prostate diseases and is closely related to multiple factors such as the increase in the prevalence of metabolic syndrome, dietary habits, inadequate fluid intake, physical inactivity, obesity, and climate change. This situation increases the clinical burden of the disease, leading to a decrease in the quality of life of individuals and the development of various physical and psychological problems during the treatment process.

Extracorporeal shock wave lithotripsy (ESWL) is a widely used non-invasive method in the treatment of urolithiasis. ESWL uses shock waves to break kidney stones into smaller pieces, which are then passed through the urinary tract. Current urolithiasis guidelines emphasize that treatment selection should be individualized, taking into account the stone's size and location, as well as its density and the patient's anatomical conditions. According to guidelines published by the European Association of Urology and the American Urological Association, ESWL or retrograde intrarenal surgery (RIRS) are among the primary treatment options for kidney stones smaller than 20 mm, while percutaneous nephrolithotomy (PCNL) is recommended for kidney stones 20 mm and larger. In addition, it recommends ESWL as the first-line treatment for lower calyx stones smaller than 10 mm, provided that the appropriate stone composition and anatomical conditions are met. The current literature shows that ESWL has complication rates similar to or lower than those of ureteroscopic lithotripsy (URSL), RIRS, and PCNL and offers shorter hospital stays. However, uncertainties regarding the patient experience, including treatment success and the need for retreatment, remain.

Although ESWL is generally considered a safe and effective method, uncertainties regarding the procedure and insufficient information can cause increased anxiety in patients.Increased anxiety levels can heighten pain perception, thereby increasing the need for analgesics and negatively affecting treatment compliance. Furthermore, complications such as pain, hematuria, nausea and vomiting, and infection that may occur in the post-procedure period can lead to a decrease in patients' quality of life and repeated visits to healthcare facilities.

The role of nurses in the pre- and post-procedure care of patients undergoing ESWL treatment extends beyond technical care to include improving the patient's experience through patient education and psychosocial support. Nurses make significant contributions by identifying potential contraindications to ESWL, planning appropriate patient preparation, and enhancing procedure safety through comprehensive pre-procedure assessments. In addition, patient education led by nurses plays a critical role in increasing patients' knowledge and awareness of lifestyle adjustments and preventive approaches to reduce the recurrence of urolithiasis.

A review of the current literature reveals a limited number of studies that jointly evaluate the effect of structured patient education led by nurses on key psychosocial outcomes, such as anxiety levels and quality of life, in patients undergoing ESWL treatment. This situation underscores the need for interventional studies to assess the comprehensive effects of these educational interventions on patient-centered outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

188

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)
    • Lecturer
      • Konya, Lecturer, Turkey (Türkiye), 42020
        • Konya City Hospital, Department of Urology

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

Yes

Description

Inclusion Criteria:

  • Age between 18 and 65 years
  • Diagnosed with urolithiasis
  • Scheduled for elective extracorporeal shock wave lithotripsy (ESWL)
  • Undergoing ESWL treatment for the first time
  • Able to communicate and provide informed consent

Exclusion Criteria:

  • Previous ESWL treatment
  • Emergency urolithiasis requiring urgent intervention
  • Renal failure
  • Active urinary tract infection
  • Coagulation disorders
  • Presence of severe cardiopulmonary comorbidities
  • Inability to discontinue anticoagulant or antiplatelet therapy
  • Pregnancy

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group - Standard Patient Information
Patients in the control group received routine care in accordance with the institution's ESWL procedures. Standard pre-procedure information, including brief verbal instructions, was provided by clinical staff. Control group participants were provided with educational materials after the study was completed for ethical reasons.
Experimental: Intervention Group - Nurse-Led Structured Patient Education
A structured patient education program led by nurses was implemented for patients in the intervention group, covering the period before and after the ESWL procedure. The education program was prepared in line with current scientific studies related to the urolithiasis guidelines published by the European Association of Urology and the American Urological Association.The content validity of the educational materials was assessed by expert opinion. The draft modules prepared in this context were presented to a five-member expert panel comprising two urology nurses, a surgical nursing academic, a nurse with experience in patient education, and a urology specialist. Each expert was asked to evaluate each module using a 4-point rating system for content appropriateness, scientific accuracy, comprehensibility, and clinical applicability.
Other: Intervention Group

Training program content

  • Introduction to the ESWL procedure
  • Pre-procedure preparation process
  • Experiences that may occur during the procedure
  • Pain management and relaxation strategies
  • Complication management
  • Stone fragment passage process
  • Fluid intake and mobilization
  • Prevention of recurrence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome:
Time Frame: Baseline (pre-procedure) and 4 weeks after discharge

One of the methods used to assess anxiety level, the State-Trait Anxiety Inventory (STAI), was developed by Spielberger in 1983 and adapted into Turkish by Öner and Le Compte. The STAI consists of two subscales, each with 20 items, that assess state and trait anxiety levels. All items on the scale are four-point Likert-type. Total scores on the scale range from 20 to 80, with higher scores indicating higher anxiety levels.

The Short Form-12 (SF-12) Health Status Questionnaire, used to assess quality of life, was developed by Ware and colleagues as part of the Medical Outcomes Study. The scale consists of two summary components: physical and mental health . Total scores range from 0 to 100, with higher scores indicating better quality of life. The Turkish validity and reliability study of the scale was conducted by Soylu and Kütük.
Baseline (pre-procedure) and 4 weeks after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome:
Time Frame: Baseline (pre-procedure), post procedure and 4 weeks after discharge.
Pain level was determined as the secondary outcome variable. Pain intensity was assessed using the VAS, a valid and reliable measurement tool. The scale consists of a 10 cm horizontal line, where 0 indicates "no pain," and 10 indicates "unbearable pain." Pain measurements were taken before the procedure, after the procedure, and at 4 weeks post-discharge.
Baseline (pre-procedure), post procedure and 4 weeks after discharge.

Collaborators and Investigators

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

Sponsor

KTO Karatay University

Investigators

  • Principal Investigator: Cemile Nida Kayış, KTO Karatay University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

September 25, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 6, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESWL-EDU-RCT-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data collected in this study will not be shared with other researchers in order to protect participant confidentiality and comply with data protection regulations. The data will be accessed only by the research team and will be analyzed in an anonymized manner. Study findings will be reported at an aggregate level, and no individual-level data will be made publicly available.

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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