NCT07486427

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

November 17, 2025

Last Update Submit

March 18, 2026

Conditions

Keywords

emergence agitationparental anxietysociodemographic characteristics

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of emergence agitation

    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 Outcomes (3)

  • Parental preoperative anxiety

    during the preoperative day and the day of surgery

  • Preoperative anxiety in children

    During the day of surgery

  • Postoperative pain

    During the first 30 minutes in the post-anesthesia care unit (PACU)

Study Arms (1)

observational

No intervention - cross sectional analysis

Other: No intervention - observational study

Interventions

no group

observational

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, 55139, Turkey (Türkiye)

Location

Related Publications (5)

  • Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.

  • Ali AB, Khan F. Emergence Delirium and Its Association with Preoperative Anxiety in Paediatric Patients Undergoing Infra Umbilical Surgery Under Combined General and Caudal Anaesthesia: An Observational Study from a Tertiary Care Centre in a South Asian Country. Turk J Anaesthesiol Reanim. 2022 Apr;50(2):129-134. doi: 10.5152/TJAR.2021.1104.

  • Alves CS, Dias J, Azevedo S, Sousa F, Santos M, Lino J, Meireles L. Keep Calm: Does parental preoperative anxiety affect post-tonsillectomy pain scores in children? Eur Arch Otorhinolaryngol. 2024 Aug;281(8):4385-4392. doi: 10.1007/s00405-024-08683-0. Epub 2024 May 13.

  • Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.

  • Yu H, Sun X, Li P, Deng X. Prevalence and risk factors of emergence agitation among pediatric patients undergo ophthalmic and ENT Surgery: a cross-sectional study. BMC Pediatr. 2023 Nov 24;23(1):598. doi: 10.1186/s12887-023-04434-y.

Related Links

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Dilek Gemici, Specialist physician

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2025

First Posted

March 20, 2026

Study Start

March 1, 2024

Primary Completion

October 31, 2024

Study Completion

February 15, 2025

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations