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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Gulhane Training and Research Hospital | Recruiting | Ankara | Turkey (Türkiye) |
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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.
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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.
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| 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. |
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| 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. |
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| 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 |