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

NCT07343388 | Completed Results

• 1 other identifier: GOA-155
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Emergence Delirium in Pediatric Anesthesia; Preoperative Anxiety; Urogenital Diseases; Postoperative Pain

Keywords

preoperative anxiety; postoperative pain; Postoperative Complications; mYPAS; FLACC Scale; Aldrete Score; PAED Scale

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (1)

• Postoperative Physical Recovery and Discharge Readiness

  Postoperatively at 0, 15, 30, 45, and 60 minutes.

Study Arms (1)

Pediatric Urogenital Surgery Group

Other: Standardized Perioperative Management and Observational Assessment

Interventions

Standardized Perioperative Management and Observational Assessment OTHER

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."

Pediatric Urogenital Surgery Group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead
• Dr. Behcet Uz Children's Hospital: collaborator

Study Sites (1)

Dr. Behcet Uz Children's Hospital

Izmir, Konak, 35210, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 33313588 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Urogenital Diseases; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Gonul Sari
• Organization: University of Health Sciences, Dr. Behcet Uz Children's Hospital

drgonulsari@gmail.com

5426463501

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Anesthesiology and Pain Medicine Fellow, Division of Algology, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-04

Locations

TU (1)