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

Effect of Watching a Preoperative Educational Cartoon on Anxiety in Children Aged 7 to 12 Years Undergoing Elective Procedures: A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Preoperative Anxiety
• Intervention / Treatment: Behavioral: Educational Cartoon; Behavioral: Standard Verbal Information; Behavioral: Distractor Cartoon

Detailed Description

Preoperative anxiety is common in children and may negatively affect cooperation, perioperative behavior, and the overall surgical experience. This study is designed to evaluate whether a child-friendly educational cartoon can reduce preoperative anxiety more effectively than a distractor cartoon or standard verbal information alone in children undergoing elective procedures under general anesthesia. The study is being conducted at a single center and is planned as a prospective randomized controlled clinical trial. A total of 159 pediatric patients aged 7 to 12 years will be enrolled, with 53 participants allocated to each study arm. 

Participants will be randomized into three groups. In Group 1, children will watch an educational cartoon entitled "Shuko Is Having Surgery," developed by the research team to explain preoperative preparation, induction of anesthesia, and the operating room environment in child-friendly language. In Group 2, children will watch an age-appropriate distractor cartoon previously preferred by the child; cartoon selection will exclude violent or frightening content and will be approved by the parent. In Group 3, no video will be shown and participants will receive routine standard verbal preoperative information only. Video viewing will last approximately 8 to 10 minutes and will be performed in the preoperative waiting area using the same device and environmental conditions. After video viewing, routine verbal information will also be provided according to standard practice. All children will receive oral midazolam 0.5 mg/kg as routine premedication approximately 20 to 30 minutes before video viewing or verbal information, using the same standardized protocol across all groups. 

The primary outcome measure is the child's preoperative anxiety level assessed with the Modified Yale Preoperative Anxiety Scale (mYPAS) at the preinduction period after completion of the assigned intervention. Secondary outcomes include the child's self-reported situational anxiety assessed by the State-Trait Anxiety Inventory for Children-State form (STAIC-State), parental preoperative anxiety and information requirement assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS), and perioperative physiological parameters including heart rate, systolic and diastolic blood pressure, and oxygen saturation. These measures will be used to compare the effectiveness of the three information strategies and to explore the relationship between anxiety scores and physiological stress responses. 

Eligible participants are children aged 7 to 12 years scheduled for elective procedures under general anesthesia, classified as American Society of Anesthesiologists physical status I or II, whose parents provide written informed consent and who provide age-appropriate verbal assent. Exclusion criteria include a history of neurological or psychiatric disease, developmental delay or cognitive impairment, previous anesthesia experience, visual or hearing impairment preventing video viewing, and refusal of participation by the child or parent. Participation is voluntary, and withdrawal from the study will not affect medical care. Data will be recorded using coded identifiers only and stored securely with access limited to the research team.

• Study Type: Interventional
• Enrollment (Estimated): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Recruiting
    • University of Health Sciences Gulhane Training and Research Hospital
    • Contact: Mehmet burak Eskin, Md; Phone Number: +90 530 230 7851; Email: mehmetburak.eskin@sbu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational Cartoon Plus Standard Verbal Information; 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; 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: 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.
Active Comparator: Distractor Cartoon Plus Standard Verbal Information; 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: 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.; 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.
Active Comparator: Standard Verbal Information Only; 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; Routine standard preoperative verbal information provided to the child about the surgical process, anesthesia, and the operating room environment according to institutional practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Anxiety Inventory for Children-State Form (STAIC-State) Score	Child self-reported situational anxiety measured using the State-Trait Anxiety Inventory for Children-State form (STAIC-State). Total score ranges from 20 to 60, with higher scores indicating greater anxiety.	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	Parent-reported preoperative anxiety and information requirement measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Total score ranges from 6 to 30; higher scores indicate greater anxiety and information need.	Immediately after completion of the assigned intervention during the child's preinduction period, before induction of anesthesia
Heart Rate	Heart rate measured by standard noninvasive operating room monitoring as a physiological indicator associated with preoperative anxiety.	During the child's preinduction period, before induction of anesthesia

Collaborators and Investigators

• Sponsor: Mehmet Burak Eşkin

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): December 6, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Child; General Anesthesia; Preoperative Anxiety; Modified Yale Preoperative Anxiety Scale; APAIS; Amsterdam Preoperative Anxiety and Information Scale; Educational Cartoon
• Other Study ID Numbers: 2026/61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No