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Recruiting NCT07689305

Live Parent-Child Video Interaction and Cartoon Watching for Emergence Agitation in Children

Conditions: Emergence Delirium, Preoperative Anxiety

Sex: All
Ages: 2 Years – 6 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Izmir City Hospital

Location: Izmir City Hospital Izmir İzmir

Summary

Preoperative anxiety is common in preschool-aged children and may make anesthesia induction more difficult and contribute to agitation during recovery from general anesthesia. Non-drug distraction methods may help children cope with separation from their parents and the unfamiliar operating room environment. This single-center randomized controlled trial will include 150 children aged 2 to 6 years undergoing elective surgery under general anesthesia. Participants will be assigned equally to one of three groups: live video interaction with a parent using a tablet, watching an age-appropriate cartoon, or standard care without video-based distraction. The interventions will be applied during transfer to the operating room and will end immediately before anesthesia induction. Children's preoperative anxiety will be assessed at parent separation and at the beginning of anesthesia induction using the Modified Yale Preoperative Anxiety Scale-Short Form. Agitation during recovery will be evaluated in the post-anesthesia care unit using the Pediatric Anesthesia Emergence Delirium scale. The primary objective is to determine whether live video interaction with a parent or cartoon watching reduces emergence agitation compared with standard care. The study will also compare the effects of these approaches on preoperative anxiety and explore whether live parent-child interaction is more effective than passive cartoon distraction.

Eligibility Criteria

Inclusion Criteria: * Children aged 2 to 6 years. * Scheduled to undergo an elective surgical procedure. * Scheduled to undergo surgery under general anesthesia. * American Society of Anesthesiologists (ASA) physical status I or II. * Able to communicate in Turkish and understand verbal instructions. * Written informed consent obtained from a parent or legal guardian. * No pharmacological premedication planned during the preoperative period. * No serious systemic disease and no use of sedative or psychotropic medication Exclusion Criteria: * History of neurodevelopmental delay, psychiatric illness, or a significant behavioral disorder. * Significant visual or hearing impairment that limits communication. * Use of sedative, hypnotic, or psychotropic medication within the previous 2 weeks. * Requirement for pharmacological premedication or additional sedation during the intraoperative period. * Serious systemic disease or ASA physical status III or higher. * A protocol deviation during anesthesia or surgery, including complications or cancellation of surgery. * Inability to obtain written informed consent from a parent or legal guardian. * Inability to comply with the assigned intervention or inability to complete the video-based i

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Source: ClinicalTrials.gov (NCT07689305). StuddyBuddy aggregates publicly available trial information.