Clinical Trial

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

Completed
View on ClinicalTrials.gov →
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).
Protocol Amendment History 3 changes
critical Trial completed 2026-04-25
notable Enrollment increased: 60 -> 114 participants 2026-04-25
minor Completion moved earlier: 2026-06 -> 2026-03-15 2026-04-25
Trial Details
NCT Number NCT07343388
Lead Sponsor Aydin Adnan Menderes University
Collaborators: Dr. Behcet Uz Children's Hospital
Conditions Postoperative Pain, Preoperative Anxiety, Emergence Delirium in Pediatric Anesthesia, Urogenital Diseases
Enrollment 114 participants
Start Date 2026-01-01
Primary Completion 2026-03-15 (estimated)
Study Completion 2026-03-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-24