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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group - Standard Patient Information | No Intervention | 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. | |
| Intervention Group - Nurse-Led Structured Patient Education | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group | Other | Training program content
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome: | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome: | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cemile Nida Kayış | KTO Karatay University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konya City Hospital, Department of Urology | Konya | Lecturer | 42020 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40268592 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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| D052801 | Male Urogenital Diseases |
| D001523 | Mental Disorders |