Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07425405
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT07425405
Study Brief:
Protocol Section:
NCT07425405