Actively Recruiting

Phase Not Applicable
Age: 7Years - 12Years
All Genders
NCT07495878

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

Led by Mehmet Burak Eşkin · Updated on 2026-03-30

159

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 7Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 7 to 12 years
  • Scheduled for an elective procedure under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I or II
  • Willingness of both the child and the parent to participate
  • Written informed consent from the parent and verbal assent from the child
Not Eligible

You will not qualify if you...

  • History of neurological or psychiatric disease
  • Developmental delay or cognitive impairment
  • Previous anesthesia experience
  • Visual or hearing impairment that would prevent watching the video
  • Inability to obtain parental consent or refusal of participation by the child

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Health Sciences Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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