An observational study in Agitation and Postoperative Agitation, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational
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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.
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.
231 studies on the registry are indexed under Psychomotor Agitation; 28 are open to participants now.
This study's planned enrollment of 288 is above the median of 138 across 31 observational studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 225 studies on the registry; 35 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Association Between Daily Screen Time and PAED Score
Correlation between daily screen exposure duration (continuous variable) and PAED score.
Time frame: Within the first 30 minutes after emergence from anesthesia
Age at First Screen Exposure and Emergence Delirium
Association between age at first screen exposure and PAED score.
Time frame: 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.
Time frame: 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.
Time frame: Within the first 30 minutes postoperatively
Parental Screen Use and Emergence Delirium
Association between parental daily screen use and PAED score.
Time frame: 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.
Time frame: Within the first 30 minutes postoperatively
Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
Of 19 observational studies under Psychomotor Agitation, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 32. This study's planned 12 months is close to that.
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