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Evaluation of the Impact of Preoperative Anxiety on Postoperative Pain and Emergence Delirium in Patients Undergoing Pediatric Urogenital Surgery: A Prospective Observational Study
Sponsor study identifier
observational
114
1 country
1
Study Start
January 1, 2026
Actual (reported)Primary Completion
March 15, 2026
Actual (reported)Study Completion
March 15, 2026
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 15, 2026
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2026
Actual (reported)January 7, 2026
Actual (reported)January 15, 2026
Actual (reported)March 15, 2026
Actual (reported)March 15, 2026
Actual (reported)April 24, 2026
Actual (reported)Postoperative Pain Intensity
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).
Postoperatively at 0, 15, 30, 45, and 60 minutes.
Incidence and Severity of Emergence Delirium
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.
Postoperatively at 0, 15, 30, 45, and 60 minutes.
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."
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The study population consists of pediatric patients aged 2 to 7 years who are scheduled for elective urogenital surgical procedures at a tertiary pediatric training and research hospital. The cohort specifically focuses on patients undergoing common inguinoscrotal surgeries, including hypospadias repair, orchidopexy, and hydrocele surgery, under standardized general anesthesia. Participants are selected from patients who meet the ASA I-II physical status criteria and have no underlying neurological or psychiatric conditions that could interfere with anxiety and delirium assessments.
Dr. Behcet Uz Children's Hospital
Izmir, Konak, 35210, Turkey (Türkiye)
Topalel S, Orekici Temel G, Azizoglu M. Evaluation of Preoperative Anxiety in Turkish Paediatric Patients and Validity and Reliability of the Turkish Modified Yale Preoperative Anxiety Scale. Turk J Anaesthesiol Reanim. 2020 Dec;48(6):484-490. doi: 10.5152/TJAR.2020.116. Epub 2020 May 18.
114 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2026
First Posted
January 15, 2026
Study Start
January 1, 2026
Actual (reported)Postoperative Physical Recovery and Discharge Readiness
Postoperatively at 0, 15, 30, 45, and 60 minutes.
Contact the study team to confirm eligibility.
Primary Completion
March 15, 2026
Actual (reported)Study Completion
March 15, 2026
Actual (reported)Last Updated
April 24, 2026
Results First Posted
April 24, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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