Skip to main content
OpenTrials
Completed

NCT Number: NCT07486427

Effects of Preoperative Child and Parental Anxiety on Emergence Agitation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Emergence Agitation Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuz Mayis University

Samsun, 55139, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NO intervention - observational study

Other

no group

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 20, 2026
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.