Effects of Preoperative Child and Parental Anxiety on Emergence Agitation

March 18, 2026 updated by: Deniz Karakaya, Ondokuz Mayıs University

The Effect of Preoperative Child and Parental Anxiety on Emergence Agitation and Postoperative Pain in Children Undergoing Adenoidectomy and Tonsillectomy: a Prospective Observational Study

Investigation of the effect of preoperative parental anxiety and sociodemographic characteristics on emergence agitation in patients undergoing pediatric adenotonsil surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adenotonsillectomy, with or without adenoidectomy, is one of the most commonly performed surgical procedures worldwide in pediatric patients. Despite its widespread application, this surgery presents significant challenges for both surgeons and anesthesiologists due to the associated increased risks of morbidity and mortality. Safe administration of anesthesia is critical in avoiding complications and alleviating not only patient distress but also parental anxiety.

Preoperative anxiety in pediatric patients is influenced by several factors, including young age and parental concerns. Additionally, longer surgery durations (>30 minutes) and previous hospitalizations are known risk factors for heightened anxiety. Several previous studies have explored the relationship between parental stress levels and postoperative complications, including emergence agitation and pain. Research indicates a significant association between parental anxiety and postoperative behavioral disturbances in children.

The primary objective of this study is to evaluate the impact of preoperative parental anxiety and sociodemographic characteristics on the incidence and severity of emergence agitation in pediatric patients undergoing adenotonsillectomy.

Study Type

Observational

Enrollment (Actual)

99

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

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

Probability Sample

Study Population

Pediatric patients aged 3-7 years who underwent adenotonsil surgery in the ear, nose, throat (ENT) operating room of Ondokuz Mayıs University Hospital and their parents

Description

Inclusion Criteria:

  • Patients aged 3-7 years who will undergo adenoidectomy, adenotonsillectomy or tonsillectomy surgery and their parents
  • Patients with ASA (American Society of Anesthesiologists) physical status I/II

Exclusion Criteria:

  • Patients with ASA score III and above
  • Conditions that prevent communication with the patient or parent (mental retardation, disability etc.)
  • Patients in whom routinely scheduled anesthetic and analgesic drugs cannot be administered due to allergy or contraindication
  • Patients who have previously received anesthesia or entered the operating room for a surgical procedure

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
observational
No intervention - cross sectional analysis
Other: No intervention - observational study
no group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of emergence agitation
Time Frame: From 1 to 30 minutes after extubation
The incidence and severity of emergence agitation (EA) were evaluated in the postoperative recovery room using the Watcha Behavior Scale (WBS). The Watcha Behavior Scale is a four-point scale used to assess the severity of emergence agitation in pediatric patients after anesthesia: (1) calm and cooperative; (2) mild restlessness but easily consoled; (3) agitated and inconsolable; and (4) severely agitated, thrashing, or combative.
From 1 to 30 minutes after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental preoperative anxiety
Time Frame: during the preoperative day and the day of surgery
Parental preoperative anxiety was assessed after study enrollment. For patients admitted one day before surgery, evaluation was conducted on the evening before; for those admitted on the day of surgery, it was performed in the preoperative waiting area. Anxiety levels were measured using the State-Trait Anxiety Inventory (STAI), which consists of two subscales: the State Anxiety Inventory (STAI-S) and the Trait Anxiety Inventory (STAI-T), each including 20 items. Each item is rated on a 4-point Likert scale, with total scores ranging from 20 to 80 for each subscale. Higher scores indicate higher levels of anxiety.
during the preoperative day and the day of surgery
Preoperative anxiety in children
Time Frame: During the day of surgery
Children were accompanied by a parent until transfer to the operating room (OR). Preoperative anxiety levels were assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) before separation from parents and prior to any intervention or drug administration. The m-YPAS is an observational scale with scores ranging from 23.33 to 100, with higher scores indicating greater anxiety.
During the day of surgery
Postoperative pain
Time Frame: During the first 30 minutes in the post-anesthesia care unit (PACU)
Postoperative pain was assessed in the post-anesthesia care unit (PACU) using the Wong-Baker Faces Pain Rating Scale. This scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain. Higher scores indicate greater pain intensity. Pain scores were recorded at predefined time points during the early postoperative period.
During the first 30 minutes in the post-anesthesia care unit (PACU)

Collaborators and Investigators

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

Sponsor

Ondokuz Mayıs University

Investigators

  • Principal Investigator: Dilek Gemici, Specialist physician, Ondokuz Mayıs University

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

Helpful Links

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)

March 1, 2024

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

February 15, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA140324

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.

Clinical Trials on Emergence Agitation

Clinical Trials on No intervention - observational study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe