NephrolithiasisNCT07772830
Preoperative Anxiety in Patients Undergoing RIRS and PCNL
An observational study of Nephrolithiasis and Preoperative Anxiety, run by Emrah Küçük at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aimed to compare preoperative anxiety levels in adult patients undergoing retrograde intrarenal surgery (RIRS) or percutaneous nephrolithotomy (PCNL) for renal stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, Preoperative Anxiety
- What is being tested?
- Retrograde Intrarenal Surgery and Percutaneous Nephrolithotomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2024to 20 Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with renal stones who were scheduled to undergo retrograde intrarenal surgery (RIRS) or percutaneous nephrolithotomy (PCNL) at the Urology Clinic of Samsun University, Samsun Training and Research Hospital, during the study period. Participants were prospectively enrolled from patients receiving routine clinical care, and the choice of surgical procedure was determined independently of the study protocol.
Who may be able to join
- Patients over 18 years of age
- Patients scheduled to undergo RIRS or PCNL for renal stones
- Patients scheduled to undergo general anesthesia
- Patients who had not previously undergone general anesthesia
Who cannot join
- Patients scheduled to undergo spinal anesthesia
- Patients undergoing RIRS or PCNL for ureteral stones
- Patients with a history of general anesthesia
- Patients with psychiatric or neurological disorders
- Patients using anxiolytic or antidepressant medications
- Patients with chronic alcoholism
- Patients with a history of previous stone surgery
- Patients with known congenital renal or urinary tract anomalies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University, Samsun Training and Research Hospital
Samsun, Samsun, 55080
About this study
Official title: Preoperative Anxiety in Patients Undergoing RIRS and PCNL: A Prospective Comparative Study
This prospective observational cohort study aimed to compare preoperative anxiety levels in adult patients undergoing retrograde intrarenal surgery (RIRS) or percutaneous nephrolithotomy (PCNL) for renal stones. The surgical approach was determined according to routine clinical indications and was not assigned by the study protocol. Preoperative anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Demographic, clinical, and stone-related characteristics were also recorded to evaluate factors associated with preoperative anxiety.
Read the detailed description
Adult patients scheduled to undergo RIRS or PCNL for the treatment of renal stones were prospectively enrolled in this single-center observational cohort study. The choice of surgical approach was based on routine clinical assessment, including stone characteristics, anatomical considerations, and the treating urologist's clinical judgment, and was not determined by the research protocol.
Before surgery, participants completed the State-Trait Anxiety Inventory-State (STAI-S) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Demographic characteristics, comorbidities, American Society of Anesthesiologists (ASA) physical status, and stone-related variables were prospectively recorded.
The primary objective was to compare preoperative anxiety levels between patients undergoing RIRS and those undergoing PCNL. The study also evaluated clinical and patient-related factors potentially associated with preoperative anxiety.
- Conditions
- Nephrolithiasis, Preoperative Anxiety
- Being tested
- Retrograde Intrarenal Surgery, Percutaneous Nephrolithotomy
- Keywords
- RIRS, PCNL, STAI-S, APAIS
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde Intrarenal SurgeryProcedure or surgery
Retrograde intrarenal surgery (RIRS) performed for the treatment of renal stones according to routine clinical indications. The procedure was not assigned by the study protocol.
Percutaneous NephrolithotomyProcedure or surgery
Percutaneous nephrolithotomy (PCNL) performed for the treatment of renal stones according to routine clinical indications. The procedure was not assigned by the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| RIRS Group | Participants with renal stones who underwent retrograde intrarenal surgery (RIRS) as part of routine clinical care. The surgical approach was determined independently of the study protocol. Receives: Procedure: Retrograde Intrarenal Surgery | |
| PCNL Group | Participants with renal stones who underwent percutaneous nephrolithotomy (PCNL) as part of routine clinical care. The surgical approach was determined independently of the study protocol. Receives: Procedure: Percutaneous Nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
Preoperative state anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S). The STAI-S consists of 20 items and yields a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
Measured: On the day of surgery, before the surgical procedure
Preoperative State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
Preoperative state anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S). The STAI-S consists of 20 items and provides a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
Measured: Preoperatively, on the day of surgery before the surgical procedure
Secondary outcomes (1)
Preoperative Anxiety Measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Preoperative anxiety was assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The six-item scale evaluates anxiety related to anesthesia and surgery and the need for information, with higher scores indicating greater preoperative anxiety and/or information need.
Measured: Preoperatively, on the day of surgery before the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start20 Jan 2024
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emrah Küçük
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emrah Küçük, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772830
- Sponsor's protocol ID
- GOKAEK 2024/1/3
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because a formal data-sharing plan was not established in the original study protocol. De-identified data may be considered for sharing upon reasonable request and subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Anxiety in Patients Undergoing RIRS and PCNL: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07772830
- Acronym / sponsor ID
- GOKAEK 2024/1/3
- Conditions
- Nephrolithiasis, Preoperative Anxiety
- Keywords
- RIRS, PCNL, STAI-S, APAIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Emrah KüçükUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 19 Aug 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.
This prospective observational cohort study aimed to compare preoperative anxiety levels in adult patients undergoing retrograde intrarenal surgery (RIRS) or percutaneous nephrolithotomy (PCNL) for renal stones. The surgical approach was determined according to routine clinical indications and was not assigned by the study protocol. Preoperative anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Demographic, clinical, and stone-related characteristics were also recorded to evaluate factors associated with preoperative anxiety.
Detailed description
Adult patients scheduled to undergo RIRS or PCNL for the treatment of renal stones were prospectively enrolled in this single-center observational cohort study. The choice of surgical approach was based on routine clinical assessment, including stone characteristics, anatomical considerations, and the treating urologist's clinical judgment, and was not determined by the research protocol.
Before surgery, participants completed the State-Trait Anxiety Inventory-State (STAI-S) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Demographic characteristics, comorbidities, American Society of Anesthesiologists (ASA) physical status, and stone-related variables were prospectively recorded.
The primary objective was to compare preoperative anxiety levels between patients undergoing RIRS and those undergoing PCNL. The study also evaluated clinical and patient-related factors potentially associated with preoperative anxiety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIRS Group | – | Procedure: Retrograde Intrarenal SurgeryParticipants with renal stones who underwent retrograde intrarenal surgery (RIRS) as part of routine clinical care. The surgical approach was determined independently of the study protocol. |
| PCNL Group | – | Procedure: Percutaneous NephrolithotomyParticipants with renal stones who underwent percutaneous nephrolithotomy (PCNL) as part of routine clinical care. The surgical approach was determined independently of the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with renal stones who were scheduled to undergo retrograde intrarenal surgery (RIRS) or percutaneous nephrolithotomy (PCNL) at the Urology Clinic of Samsun University, Samsun Training and Research Hospital, during the study period. Participants were prospectively enrolled from patients receiving routine clinical care, and the choice of surgical procedure was determined independently of the study protocol.
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Patients scheduled to undergo RIRS or PCNL for renal stones
- Patients scheduled to undergo general anesthesia
- Patients who had not previously undergone general anesthesia
Key exclusion criteria (8 listed)
- Patients scheduled to undergo spinal anesthesia
- Patients undergoing RIRS or PCNL for ureteral stones
- Patients with a history of general anesthesia
- Patients with psychiatric or neurological disorders
- Patients using anxiolytic or antidepressant medications
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 |
|---|---|---|
| Retrograde Intrarenal SurgeryRetrograde intrarenal surgery (RIRS) performed for the treatment of renal stones according to routine clinical indications. The procedure was not assigned by the study protocol. | Procedure or surgery | RIRS Group |
| Percutaneous NephrolithotomyPercutaneous nephrolithotomy (PCNL) performed for the treatment of renal stones according to routine clinical indications. The procedure was not assigned by the study protocol. | Procedure or surgery | PCNL Group |
Primary outcome
Preoperative State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
Time frame: On the day of surgery, before the surgical procedure
Preoperative state anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S). The STAI-S consists of 20 items and yields a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
Preoperative State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)
Time frame: Preoperatively, on the day of surgery before the surgical procedure
Preoperative state anxiety was assessed using the State-Trait Anxiety Inventory-State (STAI-S). The STAI-S consists of 20 items and provides a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
1 secondary outcome
Preoperative Anxiety Measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: Preoperatively, on the day of surgery before the surgical procedure
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 20 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because a formal data-sharing plan was not established in the original study protocol. De-identified data may be considered for sharing upon reasonable request and subject to institutional and ethical approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrolithiasis and Preoperative Anxiety, run by Emrah Küçük 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 4 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 20 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?
Preoperative State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S) (time frame: On the day of surgery, before the surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.