UrolithiasisESWL-VAS-STAINCT07341607
Nurse-Led Patient Education in ESWL Patients
A study testing Intervention Group in people with Urolithiasis and ESWL, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis, ESWL
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2025to 6 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Konya City Hospital, Department of Urology
Konya, Lecturer, 42020
About this study
Official title: The Effect of Nurse-Led Structured Patient Education on Anxiety and Quality of Life in Patients Undergoing Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Urolithiasis, ESWL
- Being tested
- Intervention Group
- Keywords
- Urolithiasis, Patient Education, Quality of Life, Anxiety, Nurse's Role, Nursing Care
- Medical subject headings
- Urolithiasis, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-procedure) and 4 weeks after discharge
Secondary outcomes (1)
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.
Measured: Baseline (pre-procedure), post procedure and 4 weeks after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start25 Sep 2025
- Primary completion1 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile Nida Kayış, KTO Karatay University
- Investigators
- Cemile Nida Kayış, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341607
- Sponsor's protocol ID
- ESWL-EDU-RCT-2025
- Acronym
- ESWL-VAS-STAI
- Status last verified
- May 2026
- First submitted
- 6 Jan 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40268592
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse-Led Structured Patient Education on Anxiety and Quality of Life in Patients Undergoing Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07341607
- Acronym / sponsor ID
- ESWL-VAS-STAI / ESWL-EDU-RCT-2025
- Conditions
- Urolithiasis, ESWL
- Keywords
- Urolithiasis, Patient Education, Quality of Life, Anxiety, Nurse's Role, Nursing Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Intervention GroupA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Previous ESWL treatment
- Emergency urolithiasis requiring urgent intervention
- Renal failure
- Active urinary tract infection
- Coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupTraining 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 | Other | Intervention Group - Nurse-Led Structured Patient Education |
Primary outcome
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.
1 secondary outcome
Secondary Outcome:
Time frame: Baseline (pre-procedure), post procedure and 4 weeks after discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 40268592Skolarikos 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cemile Nida Kayış principal investigator
KTO Karatay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Urolithiasis and ESWL, run by KTO Karatay University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: (time frame: Baseline (pre-procedure) and 4 weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07341607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.