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Recruiting NCT07552896

Effect of Daily Screen Time on Postoperative Emergence Delirium in Children Aged 2-11 Years

Observational Agitation Postoperative Agitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Daily Screen Exposure Duration.
Who it may be relevant to
Registry conditions: Agitation, Postoperative Agitation. Basic parameters: 2 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Daily Screen Exposure Duration on Postoperative Emergence Delirium in Children Undergoing Elective Lower Abdominal Surgery: A Prospective Observational Study

Overview

This prospective observational study aims to evaluate the association between daily screen exposure duration and postoperative emergence delirium in children aged 2 to 11 years undergoing elective lower abdominal surgery. Daily screen time will be assessed using a parent-reported questionnaire administered preoperatively. Postoperative emergence delirium will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale at 5, 10, 15, and 30 minutes after surgery. The primary outcome is the association between daily screen time and PAED score within the first 30 minutes postoperatively. Secondary outcomes include the associations between PAED score and age at first screen exposure, type of viewed content, parental screen use, passive screen exposure, and the presence of a screen in the child's bedroom. The study is designed to improve understanding of whether screen-related environmental factors are associated with postoperative behavioral recovery in pediatric surgical patients.

Detailed description

Postoperative emergence delirium is a common behavioral disturbance in children after general anesthesia and may be associated with delayed recovery, increased distress, and greater need for postoperative management. Environmental and behavioral factors that may influence postoperative agitation are not yet fully understood. Screen exposure has become a major part of early childhood life, and excessive or early exposure has been associated with emotional dysregulation, anxiety-related symptoms, and behavioral difficulties. However, the relationship between daily screen time and postoperative emergence delirium has not been adequately studied.

This study is a prospective, single-center, observational cohort study conducted in children aged 2 to 11 years undergoing elective lower abdominal surgery, including inguinal hernia repair, orchiopexy for undescended testis, and circumcision. After written informed consent is obtained from the parent or legal guardian, a structured questionnaire will be completed in the preoperative waiting area. The questionnaire will collect information on daily screen exposure duration, age at first screen exposure, type of content viewed, parental screen use, passive screen exposure in the home environment, and the presence of a screen in the child's bedroom. Sociodemographic and clinical variables, including age, sex, parental education status, previous surgery or anesthesia history, ASA physical status, and type of surgery, will also be recorded.

No active intervention will be applied. This is a non-interventional observational study in which daily screen exposure duration is the exposure of interest. Participants may be categorized into screen exposure groups for descriptive and comparative analyses, but the primary analysis will evaluate the association between daily screen time as a continuous variable and PAED score.

Postoperative emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium scale. PAED scoring will be performed by the study investigator at 5, 10, 15, and 30 minutes postoperatively, after the child has recovered sufficiently for assessment. Higher PAED scores indicate more severe emergence delirium symptoms.

The primary outcome measure is the association between daily screen time and PAED score within the first 30 minutes postoperatively. Secondary outcome measures include the associations between PAED score and age at first screen exposure, type of screen content, parental screen use, passive screen exposure, and the presence of a screen in the bedroom. Additional exploratory analyses may examine the influence of demographic and clinical variables on PAED scores.

Children will be excluded if they receive premedication, undergo emergency surgery or reoperation, have developmental delay, neurodevelopmental or psychiatric disorders, visual or hearing impairment interfering with behavioral assessment, current use of sedative, antipsychotic, or antiepileptic medications, anticipated postoperative intensive care requirement, or incomplete parent-reported questionnaire data.

The findings of this study may help identify screen-related factors associated with postoperative emergence delirium and may contribute to improved preoperative risk assessment and family guidance in pediatric surgical practice.

Interventions

  • Diagnostic test Daily Screen Exposure Duration
    This is a non-interventional observational study. The exposure of interest is the daily screen time duration of children aged 2-11 years, as reported by parents. Participants are categorized into two groups based on screen exposure (\<2 hours/day and \>2 hours/day). No active intervention is applied.

Primary outcome measures

  • Association Between Daily Screen Time and PAED Score [Time frame: Within the first 30 minutes after emergence from anesthesia]
Secondary outcome measures (5)
  • Age at First Screen Exposure and Emergence Delirium [Time frame: Within the first 30 minutes postoperatively]
  • Influence of Sociodemographic Factors on Emergence Delirium [Time frame: Within the first 30 minutes postoperatively]
  • Type of Screen Content and Emergence Delirium [Time frame: Within the first 30 minutes postoperatively]
  • Parental Screen Use and Emergence Delirium [Time frame: Within the first 30 minutes postoperatively]
  • Passive Screen Exposure and Emergence Delirium [Time frame: Within the first 30 minutes postoperatively]

Eligibility criteria

Inclusion criteria

  • Children aged 2 to 11 years
  • Scheduled for elective lower abdominal surgery
  • Planned procedures include inguinal hernia repair, orchiopexy for undescended testis, or circumcision
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Parent or legal guardian able to provide written informed consent
  • Parent or legal guardian able to complete the study questionnaire

Exclusion criteria

  • Planned or administered premedication before surgery
  • Emergency surgery
  • Reoperation
  • Developmental delay, neurodevelopmental disorder, or known psychiatric disease
  • Visual or hearing impairment that may interfere with behavioral assessment
  • Current use of sedative, antipsychotic, or antiepileptic medication
  • Anticipated postoperative intensive care unit requirement
  • Incomplete or unreliable parent-reported questionnaire data

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

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

Identifiers

NCT: NCT07552896 · screen time and agitation

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗