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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
275

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress56%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

February 16, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

March 11, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2026

Expected
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

February 16, 2026

Last Update Submit

March 10, 2026

Conditions

Keywords

Screen ExposurePediatric Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Preoperative Anxiety Level Assessed by mYPAS Total Score

    Preoperative anxiety will be measured using the Modified Yale Preoperative Anxiety Scale (mYPAS), a validated observational tool for children aged 2-12 years. The total score ranges from 23.3 to 100, with higher scores indicating greater anxiety. The primary analysis will compare mYPAS total scores among three daily screen exposure groups (\<1 hour/day, 1-2 hours/day, \>2 hours/day).

    Immediately before anesthesia induction

Secondary Outcomes (6)

  • Association Between Screen Content Type and Preoperative Anxiety (mYPAS)

    Immediately before anesthesia induction (Day of surgery)

  • Association Between Parental Monitoring of Screen Content and Preoperative Anxiety (mYPAS)

    Immediately before anesthesia induction (Day of surgery)

  • Association Between Passive Screen Exposure and Preoperative Anxiety (mYPAS)

    Immediately before anesthesia induction

  • Association Between Reasons for Providing Screen and Preoperative Anxiety (mYPAS)

    Immediately before anesthesia induction

  • Association Between Parental Screen Use and Preoperative Anxiety (mYPAS)

    Immediately before anesthesia induction

  • +1 more secondary outcomes

Study Arms (3)

Low Screen Exposure

Children aged 2-5 years with daily screen exposure less than 1 hour per day, as reported by parents through a structured questionnaire.

Moderate Screen Exposure

Children aged 2-5 years with daily screen exposure between 1 and 2 hours per day.

High Screen Exposure

Children aged 2-5 years with daily screen exposure greater than 2 hours per day.

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The study population consists of children aged 2-5 years scheduled for elective surgical procedures under general anesthesia at Kanuni Sultan Süleyman Training and Research Hospital. Participants will be enrolled prospectively after written informed consent is obtained from a parent or legal guardian. Children will be categorized based on parent-reported daily screen exposure duration. Preoperative anxiety will be assessed immediately before anesthesia induction using the Modified Yale Preoperative Anxiety Scale (mYPAS).

You may qualify if:

  • Children aged 2 to 5 years
  • Scheduled for elective surgical procedures under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Parent or legal guardian able to provide written informed consent
  • Parent able to complete the structured questionnaire in Turkish

You may not qualify if:

  • Premedication administered or planned prior to anxiety assessment
  • Emergency surgical procedures
  • Known developmental delay or neurodevelopmental disorder
  • Known psychiatric disorder
  • Visual or hearing impairment that may interfere with behavioral assessment
  • Chronic use of sedative, antipsychotic, or antiepileptic medications
  • Anticipated need for postoperative intensive care
  • Incomplete or unreliable questionnaire data
  • Inability to perform mYPAS assessment prior to anesthesia induction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, küçükçekmece, 34303, Turkey (Türkiye)

RECRUITING

Study Design

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

Study Record Dates

First Submitted

February 16, 2026

First Posted

February 20, 2026

Study Start

March 11, 2026

Primary Completion (Estimated)

August 23, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Locations