Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, 34303, Turkey (Türkiye)
NCT Number: NCT07552896
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 opening soon.
Get Notified2 year–11 year
All sexes
Observational
Istanbul, 34303, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Within the first 30 minutes after emergence from anesthesia
Correlation between daily screen exposure duration (continuous variable) and PAED score.
Time frame: Within the first 30 minutes postoperatively
Association between age at first screen exposure and PAED score.
Time frame: Within the first 30 minutes postoperatively
Assessment of the effect of age, sex, parental education level, and family structure on PAED scores.
Time frame: Within the first 30 minutes postoperatively
Evaluation of the relationship between type of content viewed (cartoons, games, educational, mixed) and PAED score.
Time frame: Within the first 30 minutes postoperatively
Association between parental daily screen use and PAED score.
Time frame: Within the first 30 minutes postoperatively
Evaluation of the effect of background screen exposure in the home environment on PAED score.
Contact information is provided by the study sponsor or research team.
Kanuni Sultan Suleyman Training and Research Hospital
Other
The Effect of Daily Screen Exposure Duration on Postoperative Emergence Delirium in Children Undergoing Elective Lower Abdominal Surgery: A Prospective Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07377981
Aberrant Motor Behavior in Dementia, Agitation
Nanjing, Jiangsu, China
View Trial DetailsNCT07051096
Aberrant Motor Behavior in Dementia, Agitation
Vancouver, British Columbia, Canada
View Trial DetailsNCT06993194
Aberrant Motor Behavior in Dementia, Agitation
View Trial DetailsNCT06937229
Aberrant Motor Behavior in Dementia, Agitation
Chandler, Arizona, United States
View Trial Details