Preoperative Anxiety in Patients Undergoing RIRS and PCNL

NCT07772830 | Completed

• 1 other identifier: GOKAEK 2024/1/3
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nephrolithiasis; Preoperative Anxiety

Keywords

RIRS; PCNL; STAI-S; APAIS

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  Preoperatively, on the day of surgery before the surgical procedure

Study Arms (2)

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.

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.

Procedure: Percutaneous Nephrolithotomy

Interventions

Retrograde Intrarenal Surgery PROCEDURE

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.

RIRS Group

Percutaneous Nephrolithotomy PROCEDURE

Percutaneous nephrolithotomy (PCNL) performed for the treatment of renal stones according to routine clinical indications. The procedure was not assigned by the study protocol.

PCNL Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emrah Küçük: lead

Study Sites (1)

Samsun University, Samsun Training and Research Hospital

Samsun, Samsun, 55080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: January 20, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)