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

NCT07495878 | Recruiting

• 1 other identifier: 2026/61
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preoperative Anxiety; Modified Yale Preoperative Anxiety Scale; APAIS; General Anesthesia; Child; Amsterdam Preoperative Anxiety and Information Scale; Educational Cartoon

Outcome Measures

Primary Outcomes (1)

• Modified Yale Preoperative Anxiety Scale (mYPAS) Total Score

  Observer-rated preoperative anxiety score measured using the Modified Yale Preoperative Anxiety Scale (mYPAS). Total score ranges from 0 to 100, with higher scores indicating greater anxiety.

  Immediately after completion of the assigned intervention during the child's preinduction period, before induction of anesthesia

Secondary Outcomes (3)

• State-Trait Anxiety Inventory for Children-State Form (STAIC-State) Score

  Immediately after completion of the assigned intervention during the child's preinduction period, before induction of anesthesia

• Amsterdam Preoperative Anxiety and Information Scale (APAIS) Score

  Immediately after completion of the assigned intervention during the child's preinduction period, before induction of anesthesia

• Heart Rate

  During the child's preinduction period, before induction of anesthesia

Study Arms (3)

Educational Cartoon Plus Standard Verbal Information

EXPERIMENTAL

Children in this arm will watch the educational cartoon "Shuko Is Having Surgery," which explains the operating room environment, anesthesia induction, and the perioperative process in child-friendly language. The video will be shown for approximately 8 to 10 minutes in the preoperative waiting area under standardized conditions, followed by routine standard verbal preoperative information.

Behavioral: Educational Cartoon; Behavioral: Standard Verbal Information

Distractor Cartoon Plus Standard Verbal Information

ACTIVE COMPARATOR

Children in this arm will watch an age-appropriate distractor cartoon previously preferred by the child and approved by the parent, without violent or frightening content. The video will be shown for approximately 8 to 10 minutes under the same standardized conditions as the educational cartoon arm, followed by routine standard verbal preoperative information.

Behavioral: Distractor Cartoon; Behavioral: Standard Verbal Information

Standard Verbal Information Only

ACTIVE COMPARATOR

Children in this arm will not watch any video. They will receive only routine standard verbal preoperative information about the surgical process, anesthesia, and the operating room environment according to institutional practice.

Behavioral: Standard Verbal Information

Interventions

Educational Cartoon BEHAVIORAL

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.

Educational Cartoon Plus Standard Verbal Information

Distractor Cartoon BEHAVIORAL

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.

Distractor Cartoon Plus Standard Verbal Information

Standard Verbal Information BEHAVIORAL

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

Distractor Cartoon Plus Standard Verbal Information; Educational Cartoon Plus Standard Verbal Information; Standard Verbal Information Only

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 7 to 12 years
• Scheduled for an elective procedure under general anesthesia
• American Society of Anesthesiologists (ASA) physical status I-II
• Willingness of both the child and the parent to participate
• Written informed consent from the parent and verbal assent from the child

You may not qualify if:

• 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

Sponsors & Collaborators

• Mehmet Burak Eşkin: lead

Study Sites (1)

University of Health Sciences Gulhane Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The primary outcome (mYPAS) will be assessed by an observer who is blinded to group allocation. Due to the nature of the interventions, participants, parents, and care providers will not be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized in a 1:1:1 ratio to one of three parallel groups: an educational cartoon plus standard verbal information group, a distractor cartoon plus standard verbal information group, or a standard verbal information only group.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 6, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)