Pediatric Preoperative AnxietyCALM-KIDSNCT07495878
Educational Cartoon to Reduce Preoperative Anxiety in Children (CALM-KIDS)
A study testing Educational Cartoon, Distractor Cartoon and Standard Verbal Information in people with Pediatric Preoperative Anxiety, run by Mehmet Burak Eşkin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Pediatric Preoperative Anxiety
- What is being tested?
- Educational Cartoon, Distractor Cartoon and Standard Verbal Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- History of neurological or psychiatric disease
- Developmental delay or cognitive impairment
- Visual or hearing impairment that would prevent watching the video
- Inability to obtain parental consent or refusal of participation by the child
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Gulhane Training and Research Hospital
Ankara
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Preoperative Anxiety
- Being tested
- Educational Cartoon, Distractor Cartoon, Standard Verbal Information
- Keywords
- Preoperative Anxiety, Modified Yale Preoperative Anxiety Scale, APAIS, General Anesthesia, Child, Amsterdam Preoperative Anxiety and Information Scale, Educational Cartoon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational CartoonBehavioural
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.
Distractor CartoonBehavioural
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.
Standard Verbal InformationBehavioural
Routine standard preoperative verbal information provided to the child about the surgical process, anesthesia, and the operating room environment according to institutional practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Standard Verbal Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: During the child's preinduction period, before induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start6 Mar 2026
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Burak Eşkin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Burak Eşkin, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495878
- Sponsor's protocol ID
- 2026/61
- Acronym
- CALM-KIDS
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Watching a Preoperative Educational Cartoon on Anxiety in Children Aged 7 to 12 Years Undergoing Elective Procedures: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07495878
- Acronym / sponsor ID
- CALM-KIDS / 2026/61
- Conditions
- Pediatric Preoperative Anxiety
- Keywords
- Preoperative Anxiety, Modified Yale Preoperative Anxiety Scale, APAIS, General Anesthesia, Child, Amsterdam Preoperative Anxiety and Information Scale, Educational Cartoon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Mehmet Burak EşkinUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Educational Cartoon Plus Standard Verbal Information | Experimental | Behavioral: Educational Cartoon, Behavioral: Standard Verbal InformationChildren 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. |
| Distractor Cartoon Plus Standard Verbal Information | Active comparator | Behavioral: Distractor Cartoon, Behavioral: Standard Verbal InformationChildren 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. |
| Standard Verbal Information Only | Active comparator | Behavioral: Standard Verbal InformationChildren 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- History of neurological or psychiatric disease
- Developmental delay or cognitive impairment
- Visual or hearing impairment that would prevent watching the video
- Inability to obtain parental consent or refusal of participation by the child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational CartoonA 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. | Behavioural | Educational Cartoon Plus Standard Verbal Information |
| Distractor CartoonAn 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. | Behavioural | Distractor Cartoon Plus Standard Verbal Information |
| Standard Verbal InformationRoutine standard preoperative verbal information provided to the child about the surgical process, anesthesia, and the operating room environment according to institutional practice. | Behavioural | Distractor Cartoon Plus Standard Verbal Information, Educational Cartoon Plus Standard Verbal Information, Standard Verbal Information Only |
Primary outcome
Modified Yale Preoperative Anxiety Scale (mYPAS) Total Score
Time frame: Immediately after completion of the assigned intervention during the child's preinduction period, before induction of anesthesia
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.
3 secondary outcomes
State-Trait Anxiety Inventory for Children-State Form (STAIC-State) Score
Time frame: 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
Time frame: Immediately after completion of the assigned intervention during the child's preinduction period, before induction of anesthesia
Heart Rate
Time frame: During the child's preinduction period, before induction of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Cartoon, Distractor Cartoon and Standard Verbal Information in people with Pediatric Preoperative Anxiety, run by Mehmet Burak Eşkin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Yale Preoperative Anxiety Scale (mYPAS) Total Score (time frame: Immediately after completion of the assigned intervention during the child's preinduction period, before induction of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.