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

April 6, 2026 updated by: Gonul Sari, Aydin Adnan Menderes University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Konak
      • Izmir, Konak, Turkey (Türkiye), 35210
        • Dr. Behcet Uz Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric Urogenital Surgery Group
Other: Standardized 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
Time Frame: 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).
Postoperatively at 0, 15, 30, 45, and 60 minutes.
Incidence and Severity of Emergence Delirium
Time Frame: 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.
Postoperatively at 0, 15, 30, 45, and 60 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Physical Recovery and Discharge Readiness
Time Frame: Postoperatively at 0, 15, 30, 45, and 60 minutes.
Measured using the Modified Aldrete Score, which evaluates five criteria: activity, respiration, circulation, consciousness, and oxygen saturation. Each criterion is scored 0, 1, or 2. The total score ranges from 0 to 10. Higher scores indicate better physical recovery and greater readiness for discharge from the Post-Anesthesia Care Unit (PACU). A score of 9 or 10 is typically required for safe discharge.
Postoperatively at 0, 15, 30, 45, and 60 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Collaborators

Dr. Behcet Uz Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Actual)

March 15, 2026

Study Completion (Actual)

March 15, 2026

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOA-155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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