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临床试验/NCT07772830
NCT07772830已完成不适用

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

Emrah Küçük1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Preoperative State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Preoperative State Anxiety Measured by the State-Trait Anxiety Inventory-State (STAI-S)

时间窗: 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)

时间窗: 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.

次要结局

  • Preoperative Anxiety Measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)(Preoperatively, on the day of surgery before the surgical procedure)

研究者

发起方
Emrah Küçük
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emrah Küçük

Assistant Professor

Samsun University

研究点 (1)

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