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临床试验/NCT07552896
NCT07552896招募中不适用

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

Kanuni Sultan Suleyman Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
288
试验地点
2
主要终点
Association Between Daily Screen Time and PAED Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

High Screen Exposure (>2 Hours/Day)

Children aged 2-11 years undergoing elective lower abdominal surgery with daily screen exposure of more than 2 hours, as reported by parents. Postoperative emergence delirium will be assessed using the PAED score.

干预措施: Daily Screen Exposure Duration (Diagnostic Test)

Low Screen Exposure (<2 Hours/Day)

Children aged 2-11 years undergoing elective lower abdominal surgery with daily screen exposure of less than 2 hours, as reported by parents. Postoperative emergence delirium will be assessed using the PAED score.

干预措施: Daily Screen Exposure Duration (Diagnostic Test)

结局指标

主要结局

Association Between Daily Screen Time and PAED Score

时间窗: Within the first 30 minutes after emergence from anesthesia

Correlation between daily screen exposure duration (continuous variable) and PAED score.

次要结局

  • Age at First Screen Exposure and Emergence Delirium(Within the first 30 minutes postoperatively)
  • Influence of Sociodemographic Factors on Emergence Delirium(Within the first 30 minutes postoperatively)
  • Type of Screen Content and Emergence Delirium(Within the first 30 minutes postoperatively)
  • Parental Screen Use and Emergence Delirium(Within the first 30 minutes postoperatively)
  • Passive Screen Exposure and Emergence Delirium(Within the first 30 minutes postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Engin Ihsan Turan

principal investigator

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (2)

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