- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07552896
Effect of Daily Screen Time on Postoperative Emergence Delirium in Children Aged 2-11 Years
The Effect of Daily Screen Exposure Duration on Postoperative Emergence Delirium in Children Undergoing Elective Lower Abdominal Surgery: A Prospective Observational Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Engin ihsan Turan, principal investigator
- Phone Number: +905382431114
- Email: enginihsan@hotmail.com
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34303
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
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Contact:
- Engin ihsan Turan
- Phone Number: 05382431114
- Email: enginihsan@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association Between Daily Screen Time and PAED Score
Time Frame: Within the first 30 minutes after emergence from anesthesia
|
Correlation between daily screen exposure duration (continuous variable) and PAED score.
|
Within the first 30 minutes after emergence from anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age at First Screen Exposure and Emergence Delirium
Time Frame: Within the first 30 minutes postoperatively
|
Association between age at first screen exposure and PAED score.
|
Within the first 30 minutes postoperatively
|
|
Influence of Sociodemographic Factors on Emergence Delirium
Time Frame: Within the first 30 minutes postoperatively
|
Assessment of the effect of age, sex, parental education level, and family structure on PAED scores.
|
Within the first 30 minutes postoperatively
|
|
Type of Screen Content and Emergence Delirium
Time Frame: Within the first 30 minutes postoperatively
|
Evaluation of the relationship between type of content viewed (cartoons, games, educational, mixed) and PAED score.
|
Within the first 30 minutes postoperatively
|
|
Parental Screen Use and Emergence Delirium
Time Frame: Within the first 30 minutes postoperatively
|
Association between parental daily screen use and PAED score.
|
Within the first 30 minutes postoperatively
|
|
Passive Screen Exposure and Emergence Delirium
Time Frame: Within the first 30 minutes postoperatively
|
Evaluation of the effect of background screen exposure in the home environment on PAED score.
|
Within the first 30 minutes postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- screen time and agitation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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