NCT07552896

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2027

First Submitted

Initial submission to the registry

April 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 20, 2026

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Association Between Daily Screen Time and PAED Score

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

    Within the first 30 minutes after emergence from anesthesia

Secondary Outcomes (5)

  • 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

Study Arms (2)

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.

Diagnostic Test: Daily Screen Exposure Duration

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.

Diagnostic Test: Daily Screen Exposure Duration

Interventions

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)Low Screen Exposure (<2 Hours/Day)

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study population consists of children aged 2-11 years undergoing elective lower abdominal surgery, including inguinal hernia repair, orchiopexy for undescended testis, and circumcision, at a tertiary care hospital. Participants are classified according to daily screen exposure duration based on parent-reported data. Only patients meeting the inclusion criteria and whose parents provide written informed consent will be enrolled. Children with developmental, neurological, or psychiatric disorders, or those receiving premedication, will be excluded to ensure reliable behavioral assessment using the PAED scale.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychomotor Agitation

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Central Study Contacts

Engin ihsan Turan, principal investigator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 20, 2026

First Posted

April 27, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 2, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations