AgitationNCT07552896
Effect of Daily Screen Time on Postoperative Emergence Delirium in Children Aged 2-11 Years
An observational study of Agitation and Postoperative Agitation, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Agitation, Postoperative Agitation
- What is being tested?
- Daily Screen Exposure Duration
- How many people
- 288 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 2 May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, Istanbul, 34303
Engin ihsan Turan, 05382431114, enginihsan@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Agitation, Postoperative Agitation
- Being tested
- Daily Screen Exposure Duration
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Screen Exposure DurationDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Daily Screen Exposure Duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Daily Screen Time and PAED Score
Correlation between daily screen exposure duration (continuous variable) and PAED score.
Measured: Within the first 30 minutes after emergence from anesthesia
Secondary outcomes (5)
Age at First Screen Exposure and Emergence Delirium
Association between age at first screen exposure and PAED score.
Measured: Within the first 30 minutes postoperatively
Influence of Sociodemographic Factors on Emergence Delirium
Assessment of the effect of age, sex, parental education level, and family structure on PAED scores.
Measured: Within the first 30 minutes postoperatively
Type of Screen Content and Emergence Delirium
Evaluation of the relationship between type of content viewed (cartoons, games, educational, mixed) and PAED score.
Measured: Within the first 30 minutes postoperatively
Parental Screen Use and Emergence Delirium
Association between parental daily screen use and PAED score.
Measured: Within the first 30 minutes postoperatively
Passive Screen Exposure and Emergence Delirium
Evaluation of the effect of background screen exposure in the home environment on PAED score.
Measured: Within the first 30 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552896
- Sponsor's protocol ID
- screen time and agitation
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No