NCT07341607

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 6, 2026

Last Update Submit

January 6, 2026

Conditions

UrolithiasisESWL

Keywords

UrolithiasisPatient EducationQuality of LifeAnxietyNurse's RoleNursing Care

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome:

    Change in quality of life assessed by the SF-12 Physical and Mental Component Summary scores from baseline (pre-procedure) to 4 weeks after discharge.

    Baseline (pre-procedure) and 4 weeks after discharge

Secondary Outcomes (1)

  • Secondary Outcome:

    Baseline (pre-procedure) and 4 weeks after discharge

Study Arms (2)

Control Group - Standard Patient Information

NO INTERVENTION

Intervention Group - Nurse-Led Structured Patient Education

EXPERIMENTAL

Intervention Group - Nurse-Led Structured Patient Education

Other: Intervention Group

Interventions

Intervention GroupOTHER

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 Group - Nurse-Led Structured Patient Education

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital, Department of Urology

Konya, Lecturer, 42020, Turkey (Türkiye)

Location

Related Publications (1)

  • Skolarikos A, Geraghty R, Somani B, Tailly T, Jung H, Neisius A, Petrik A, Kamphuis GM, Davis N, Bezuidenhout C, Lardas M, Gambaro G, Sayer JA, Lombardo R, Tzelves L. European Association of Urology Guidelines on the Diagnosis and Treatment of Urolithiasis. Eur Urol. 2025 Jul;88(1):64-75. doi: 10.1016/j.eururo.2025.03.011. Epub 2025 Apr 22.

    PMID: 40268592RESULT

Related Links

MeSH Terms

Conditions

UrolithiasisAnxiety Disorders

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMental Disorders

Study Officials

  • Cemile Nida Kayış

    KTO Karatay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 14, 2026

Study Start

September 25, 2025

Primary Completion

January 1, 2026

Study Completion

January 6, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)