Clinical Trial

Educational Cartoon to Reduce Preoperative Anxiety in Children (CALM-KIDS)

Study acronym: CALM-KIDS
Recruiting
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Summary
This prospective randomized controlled study aims to compare the effects of three preoperative information strategies on anxiety in children aged 7 to 12 years undergoing elective procedures under general anesthesia. Participants will be assigned to one of three groups: an educational cartoon group, a distractor cartoon group, or a standard verbal information group. In the educational cartoon group, children will watch a child-friendly cartoon prepared by the research team that explains the operating room environment, anesthesia, and the perioperative process. In the distractor cartoon group, children will watch an age-appropriate cartoon they already like, followed by standard verbal information. In the control group, children will receive standard verbal preoperative information only. The primary outcome is preoperative anxiety measured by the Modified Yale Preoperative Anxiety Scale (mYPAS) after the intervention and before induction of anesthesia. Secondary outcomes include the child's self-reported state anxiety measured by the State-Trait Anxiety Inventory for Children-State form (STAIC-State), parental anxiety and information requirement measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS), and perioperative vital signs. A total of 159 children will be enrolled at a single center.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-23.
Trial Details
NCT Number NCT07495878
Lead Sponsor Mehmet Burak Eşkin
Conditions Pediatric Preoperative Anxiety
Enrollment 159 participants
Start Date 2026-03-01
Primary Completion 2026-12-06 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-30