STRUCTURED PATIENT EDUCATION IN ESWL PATIENTS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2026-01-06

Brief Summary

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Urolithiasis is a common urological disease with an increasing prevalence and high recurrence rates, negatively affecting patients' quality of life. Extracorporeal shock wave lithotripsy is a frequently preferred non-invasive treatment option in appropriate cases; however, uncertainties related to the procedural process and inadequate patient information may lead to increased anxiety and a decline in quality of life. Structured patient education delivered under nurse leadership has emerged as a potential approach to mitigate these adverse effects. Nevertheless, studies evaluating the impact of structured patient education on anxiety levels and quality of life in patients undergoing extracorporeal shock wave lithotripsy remain limited.

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Detailed Description

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Conditions

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Urolithiasis ESWL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A total of 188 eligible patients will be enrolled in the study. Participants will be randomly assigned to the intervention or control group using permuted block randomization with a block size of four, resulting in two groups of 94 patients each. Randomization will be conducted by an independent researcher not involved in other study procedures.

The researcher delivering the intervention will not be blinded, whereas outcome assessors will be blinded to group allocation. Accordingly, the study is designed as a single-blind randomized controlled trial.

Control Group Standard patient information Intervention Group Participants in the intervention group will receive a nurse-led structured patient education program covering the pre- and post-ESWL periods. The program is based on current European Association of Urology and American Urological Association guidelines and relevant scientific literature.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control Group - Standard Patient Information

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group - Nurse-Led Structured Patient Education

Group Type EXPERIMENTAL

Intervention Group

Intervention Type OTHER

Intervention Group Patients in the intervention group will receive a nurse-led structured patient education program covering both the pre- and post-extracorporeal shock wave lithotripsy (ESWL) periods. The education program has been developed in accordance with the current urolithiasis guidelines published by the European Association of Urology (Skolarikos et al., 2025) and the American Urological Association (Akram et al., 2024), as well as relevant up-to-date scientific literature (Geraghty et al., 2023; Jiang et al., 2021; Kasab et al., 2023; Koudonas et al., 2025; Tzelves et al., 2021).

Interventions

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Intervention Group

Intervention Group Patients in the intervention group will receive a nurse-led structured patient education program covering both the pre- and post-extracorporeal shock wave lithotripsy (ESWL) periods. The education program has been developed in accordance with the current urolithiasis guidelines published by the European Association of Urology (Skolarikos et al., 2025) and the American Urological Association (Akram et al., 2024), as well as relevant up-to-date scientific literature (Geraghty et al., 2023; Jiang et al., 2021; Kasab et al., 2023; Koudonas et al., 2025; Tzelves et al., 2021).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Aged between 18 and 65 years, Diagnosed with urolithiasis, Scheduled for elective extracorporeal shock wave lithotripsy (ESWL), Undergoing ESWL for the first time.

Exclusion Criteria

Previous history of ESWL treatment, Urolithiasis cases requiring urgent intervention, Presence of renal insufficiency, active urinary tract infection, coagulopathy, or severe cardiopulmonary comorbidities, Inability to discontinue anticoagulant or antiplatelet therapy, Pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes