RecruitingNCT07343388

Relationship Between Preoperative Anxiety, Postoperative Pain, and Emergence Delirium in Pediatric Surgery

Evaluation of the Impact of Preoperative Anxiety on Postoperative Pain and Emergence Delirium in Patients Undergoing Pediatric Urogenital Surgery: A Prospective Observational Study

Sponsor

Aydin Adnan Menderes University

Enrollment

60 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Postoperative Pain Preoperative Anxiety Urogenital Diseases Emergence Delirium in Pediatric Anesthesia

Summary

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).

Eligibility

Sex: MALEMin Age: 2 YearsMax Age: 7 Years

Plain Language Summary

Simplified for easier understanding

This observational study is examining the relationship between pre-surgery anxiety in young boys and the amount of pain they experience after waking up from anaesthesia (called emergence delirium) following minor urological surgery. The goal is to better understand and eventually prevent post-operative distress in young children. **You may be eligible if...** - Your son is 2–7 years old - He is in generally good health (ASA physical status I or II) - He is scheduled for elective surgery for hypospadias repair, orchidopexy (undescended testicle), or hydrocele (fluid around the testicle) - He will have general anaesthesia - He has no history of neurological or psychiatric disorders - You as parent or guardian are willing to provide written consent **You may NOT be eligible if...** - Your child is younger than 2 or older than 7 - Your child is a girl - The surgery is an emergency or is not urogenital/inguinal - Your child has a diagnosed cognitive impairment or developmental delay Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandardized Perioperative Management and Observational Assessment

All participants will undergo a standardized general anesthesia protocol for elective urogenital surgery (hypospadias repair, orchidopexy, or hydrocele surgery). The intervention includes: Preoperative Phase: Assessment of anxiety using the mYPAS scale before induction. Intraoperative Phase: Standardized induction and maintenance of anesthesia (e.g., inhalational anesthesia with sevoflurane). Postoperative Phase: Systematic observation in the Post-Anesthesia Care Unit (PACU) using Modified Aldrete, PAED, and FLACC scales at 0, 15, 30, 45, and 60 minutes. No experimental drugs or techniques will be administered; the study focuses on the observational correlation between preoperative anxiety and recovery outcomes."