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Идёт набор NCT07425405

Daily Screen Exposure and Preoperative Anxiety in Children Aged 2-5 Years

Наблюдательное Preoperative Anxiety

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Preoperative Anxiety. Базовые параметры: 2 лет — 5 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Daily Screen Exposure Duration on Preoperative Anxiety in Children Aged 2-5 Years: A Prospective Observational Study

Обзор

This prospective observational study aims to evaluate whether daily screen exposure duration is associated with preoperative anxiety levels in children aged 2-5 years undergoing elective surgery. Screen exposure in early childhood has been associated with emotional and behavioral outcomes, including increased anxiety. However, its potential impact on anxiety in acute stress situations such as surgery has not been previously investigated. Preoperative anxiety in children is associated with difficult anesthetic induction, increased postoperative agitation, prolonged recovery, and behavioral disturbances. In this study, parents will complete a structured questionnaire assessing their child's daily screen exposure duration and related factors. Children will be categorized into three groups according to reported daily screen time: less than 1 hour per day, 1-2 hours per day, and more than 2 hours per day. Preoperative anxiety will be assessed immediately before anesthesia induction using the Modified Yale Preoperative Anxiety Scale (mYPAS), a validated observational tool for measuring anxiety in young children. No additional medical interventions will be performed beyond routine clinical care. The study seeks to determine whether higher screen exposure is associated with increased preoperative anxiety levels and to identify potential risk factors contributing to anxiety in preschool children undergoing surgery.

Подробное описание

Preoperative anxiety is a common and clinically significant problem in preschool-aged children undergoing elective surgery. Elevated anxiety levels before anesthesia induction have been associated with difficult induction, increased postoperative emergence agitation, prolonged recovery time, and long-term behavioral disturbances.

Early childhood is a critical developmental period characterized by ongoing emotional regulation maturation and increased sensitivity to environmental factors. In recent years, daily exposure to digital screens (television, tablets, smartphones) has increased substantially among children aged 2-5 years. Previous literature has linked excessive screen time with emotional dysregulation, anxiety symptoms, and behavioral problems. However, no clinical studies have investigated the relationship between daily screen exposure and preoperative anxiety in young children.

This study aims to address this gap in the literature.

Study Objective

The primary objective of this study is to evaluate the effect of daily screen exposure duration on preoperative anxiety levels in children aged 2-5 years undergoing elective surgery.

Secondary objectives include:

Evaluating the relationship between screen-related variables (age at first exposure, content type, passive exposure, parental screen time, bedroom screen presence) and preoperative anxiety.

Assessing the influence of sociodemographic and clinical variables on anxiety levels.

Determining the prevalence of clinically significant preoperative anxiety in children with high screen exposure.

Study Design

This is a single-center, prospective observational study conducted at Kanuni Sultan Süleyman Training and Research Hospital.

After obtaining written informed consent from parents or legal guardians, a structured "Sociodemographic and Screen Use Questionnaire" will be completed in the preoperative waiting area. The questionnaire includes information on daily screen exposure duration, age at first exposure, content type, parental screen use, passive exposure, bedroom screen presence, and previous medical experiences.

Children will be categorized into three groups based on reported daily screen exposure:

\<1 hour per day

1-2 hours per day

more than 2 hours per day

Anxiety Assessment

Preoperative anxiety will be assessed immediately before anesthesia induction, either upon entry into the operating room or in the induction area, prior to any pharmacologic intervention.

Anxiety will be measured using the Modified Yale Preoperative Anxiety Scale (mYPAS), a validated observational instrument for children aged 2-12 years. The scale evaluates five behavioral domains (activity, vocalization, emotional expressivity, state of arousal, and interaction with parents). Scores range from 23.3 to 100, with higher scores indicating higher anxiety levels.

Assessment will be performed by a trained anesthesiologist through direct observation without interfering with routine clinical workflow.

Risk and Safety Considerations

This study is non-interventional. No additional medical procedures will be performed. Data collection consists of a parent questionnaire and a single observational anxiety assessment. Therefore, no additional clinical risk is anticipated beyond standard care.

Первичные конечные точки

  • Preoperative Anxiety Level Assessed by mYPAS Total Score [Срок оценки: Immediately before anesthesia induction]
Вторичные конечные точки (6)
  • Association Between Screen Content Type and Preoperative Anxiety (mYPAS) [Срок оценки: Immediately before anesthesia induction (Day of surgery)]
  • Association Between Parental Monitoring of Screen Content and Preoperative Anxiety (mYPAS) [Срок оценки: Immediately before anesthesia induction (Day of surgery)]
  • Association Between Passive Screen Exposure and Preoperative Anxiety (mYPAS) [Срок оценки: Immediately before anesthesia induction]
  • Association Between Reasons for Providing Screen and Preoperative Anxiety (mYPAS) [Срок оценки: Immediately before anesthesia induction]
  • Association Between Parental Screen Use and Preoperative Anxiety (mYPAS) [Срок оценки: Immediately before anesthesia induction]
  • Association Between Parental Phone Use During Parent-Child Interaction and Preoperative Anxiety (mYPAS) [Срок оценки: Immediately before anesthesia induction]

Критерии участия

Критерии включения

  • Children aged 2 to 5 years
  • Scheduled for elective surgical procedures under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Parent or legal guardian able to provide written informed consent
  • Parent able to complete the structured questionnaire in Turkish

Критерии исключения

  • Premedication administered or planned prior to anxiety assessment
  • Emergency surgical procedures
  • Known developmental delay or neurodevelopmental disorder
  • Known psychiatric disorder
  • Visual or hearing impairment that may interfere with behavioral assessment
  • Chronic use of sedative, antipsychotic, or antiepileptic medications
  • Anticipated need for postoperative intensive care
  • Incomplete or unreliable questionnaire data
  • Inability to perform mYPAS assessment prior to anesthesia induction

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital — Istanbul

Идентификаторы

NCT: NCT07425405 · Screentime

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗