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

NCT07495878 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

  • Pediatric Preoperative Anxiety

Interventions

BEHAVIORAL

Educational Cartoon

A child-friendly educational cartoon prepared by the research team to explain preoperative preparation, anesthesia induction, the operating room environment, and equipment. The cartoon titled "Shuko Is Having Surgery" will be shown for approximately 8 to 10 minutes before surgery.

BEHAVIORAL

Distractor Cartoon

An age-appropriate cartoon previously preferred by the child and approved by the parent, selected to avoid violent or frightening content. The cartoon will be shown for approximately 8 to 10 minutes before surgery under standardized conditions.

BEHAVIORAL

Standard Verbal Information

Routine standard preoperative verbal information provided to the child about the surgical process, anesthesia, and the operating room environment according to institutional practice.

Sponsors & Collaborators

  • Mehmet Burak Eşkin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-06
Completion
2026-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07495878 on ClinicalTrials.gov