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

Mehmet Burak Eşkin

Status: Enrolling

Conditions: Pediatric Preoperative Anxiety

Treatments: Behavioral: Educational Cartoon; Behavioral: Distractor Cartoon; Behavioral: Standard Verbal Information

Study type: Interventional

Funder types: Other

Identifiers

NCT07495878

2026/61

Details and patient eligibility

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.

Full 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.

Enrollment: 159 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 3 patient groups

Educational Cartoon Plus Standard Verbal Information

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Verbal Information

Behavioral: Educational Cartoon

Distractor Cartoon Plus Standard Verbal Information

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Verbal Information

Behavioral: Distractor Cartoon

Standard Verbal Information Only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Verbal Information