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NCT Number: NCT07772830

Preoperative Anxiety in Patients Undergoing RIRS and PCNL

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.

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Key information

Conditions

Nephrolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Preoperative Anxiety Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University, Samsun Training and Research Hospital

Samsun, 55080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Preoperative Anxiety Measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Time frame: Preoperatively, on the day of surgery before the surgical procedure

    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.

Sponsors and collaborators

Lead sponsor

Emrah Küçük

Other

Registry information

Official study title

Preoperative Anxiety in Patients Undergoing RIRS and PCNL: A Prospective Comparative Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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