Evaluation of the Impact of Preoperative Anxiety on Postoperative Pain and Emergence Delirium in Patients Undergoing Pediatric Urogenital Surgery: A Prospective Observational Study
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aydin Adnan Menderes University
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Postoperative Pain Intensity
概览
简要总结
The goal of this observational study is to learn if preoperative anxiety levels can predict the quality of early postoperative recovery, pain intensity, and the occurrence of emergence delirium in pediatric patients aged 2 to 7 years undergoing elective urogenital surgery, specifically hypospadias repair, orchidopexy, and hydrocele surgery.
The main questions it aims to answer are:
Does a higher level of preoperative anxiety lead to increased postoperative pain and a higher incidence of emergence delirium?
Is there a significant relationship between preoperative anxiety and the speed of physical recovery (discharge readiness) as measured by Aldrete scores?
Researchers will compare outcomes of patients with different levels of preoperative anxiety to see if higher anxiety results in poorer recovery profiles in the immediate postoperative period.
Participants will:
Be assessed for anxiety levels using the Modified Yale Preoperative Anxiety Scale (mYPAS) immediately before anesthesia induction.
Undergo a standardized anesthesia protocol for their elective urogenital procedure (hypospadias repair, orchidopexy, or hydrocele surgery).
Be monitored in the Post-Anesthesia Care Unit (PACU) at 0, 15, 30, 45, and 60 minutes after surgery to evaluate physical recovery (Modified Aldrete Score), delirium (PAED scale), and pain intensity (FLACC scale).
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
- 2 Years 至 7 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients aged 2 to 7 years.
- •ASA (American Society of Anesthesiologists) physical status I or II.
- •Scheduled for elective urogenital surgery, specifically hypospadias repair, orchidopexy, or hydrocele surgery.
- •Scheduled to undergo general anesthesia for the procedure.
- •Patients with no history of neurological or psychiatric disorders.
- •Provision of written informed consent by the parents or legal guardians.
排除标准
- •Patients outside the specified age range (younger than 2 or older than 7 years).
- •Female patients.
- •Patients undergoing emergency surgeries or non-urogenital/non-inguinal procedures.
- •Presence of a diagnosed cognitive impairment or developmental delay.
- •Parental or legal guardian refusal to provide informed consent.
研究组 & 干预措施
Pediatric Urogenital Surgery Group
干预措施: Standardized Perioperative Management and Observational Assessment (Other)
结局指标
主要结局
Postoperative Pain Intensity
时间窗: Postoperatively at 0, 15, 30, 45, and 60 minutes.
Measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. This behavioral scale assesses pain in children who cannot communicate verbally. Each of the five categories is scored from 0 to 2, resulting in a total score ranging from 0 to 10. Higher scores indicate increased pain intensity (0: Relaxed/Comfortable, 1-3: Mild discomfort, 4-6: Moderate pain, 7-10: Severe pain/discomfort).
Incidence and Severity of Emergence Delirium
时间窗: Postoperatively at 0, 15, 30, 45, and 60 minutes.
Measured using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scale consists of five items: eye contact, purposeful actions, awareness of surroundings, restlessness, and inconsolability. The total score ranges from 0 to 20, where higher scores indicate greater severity of delirium. A score of 10 or higher is considered clinically significant for the presence of emergence delirium.
次要结局
- Postoperative Physical Recovery and Discharge Readiness(Postoperatively at 0, 15, 30, 45, and 60 minutes.)
研究者
Gonul Sari
Specialist of Anesthesiology and Pain Medicine Fellow, Division of Algology, Department of Anesthesiology and Reanimation
Aydin Adnan Menderes University