Live Parent-Child Video Interaction and Cartoon Watching for Emergence Agitation in Children (LIVE-CART Kids)
The Effect of Live Video Parent-Child Interaction and Cartoon Watching on Emergence Agitation in Children Aged 2-6 Years: A Randomized Controlled Trial
Preoperative anxiety is common in preschool-aged children and may make anesthesia induction more difficult and contribute to agitation during recovery from general anesthesia. Non-drug distraction methods may help children cope with separation from their parents and the unfamiliar operating room environment.
This single-center randomized controlled trial will include 150 children aged 2 to 6 years undergoing elective surgery under general anesthesia. Participants will be assigned equally to one of three groups: live video interaction with a parent using a tablet, watching an age-appropriate cartoon, or standard care without video-based distraction.
The interventions will be applied during transfer to the operating room and will end immediately before anesthesia induction. Children's preoperative anxiety will be assessed at parent separation and at the beginning of anesthesia induction using the Modified Yale Preoperative Anxiety Scale-Short Form. Agitation during recovery will be evaluated in the post-anesthesia care unit using the Pediatric Anesthesia Emergence Delirium scale.
The primary objective is to determine whether live video interaction with a parent or cartoon watching reduces emergence agitation compared with standard care. The study will also compare the effects of these approaches on preoperative anxiety and explore whether live parent-child interaction is more effective than passive cartoon distraction.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This is a prospective, single-center, three-arm randomized controlled trial evaluating two non-pharmacological video-based interventions for reducing preoperative anxiety and emergence agitation in children aged 2 to 6 years undergoing elective surgery under general anesthesia.
A total of 150 participants will be allocated in a 1:1:1 ratio, with 50 children in each study group. Randomization will be performed using a computer-generated block randomization sequence with a block size of six. Group assignments will be kept in sealed envelopes and opened by the person responsible for administering the intervention on the day of surgery.
In the live video interaction group, children will communicate with their parent through a tablet during transfer to the operating room. The tablet-based interaction will end immediately before anesthesia induction, and no audio or video recording will be made. In the cartoon group, children will watch a short, age-appropriate cartoon without violent or frightening content during the same perioperative period. In the control group, children will receive standard clinical care without a video-based distraction intervention.
Routine pharmacological anxiolytic or sedative premedication will not be administered to study participants. Children who require pharmacological premedication or additional sedation outside the study protocol will not be included in the final study assessments.
Preoperative anxiety will be evaluated using the Modified Yale Preoperative Anxiety Scale-Short Form at parent separation and at the beginning of anesthesia induction. Emergence agitation will be evaluated in the post-anesthesia care unit using the Pediatric Anesthesia Emergence Delirium scale. The primary outcome will be the highest Pediatric Anesthesia Emergence Delirium score observed during the post-anesthesia care unit stay. Emergence agitation will also be evaluated categorically using a Pediatric Anesthesia Emergence Delirium score of 10 or greater.
Secondary assessments will include children's preoperative anxiety scores at parent separation and anesthesia induction. Parental state anxiety will be recorded during the preoperative period using the State-Trait Anxiety Inventory-State Form. Study data will be collected using a standardized case report form.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Murat KAYKAC, M.D.
- Номер телефона: +905330258450
- Электронная почта: mrtkykc@gmail.com
Места учебы
-
-
İzmir
-
Izmir, İzmir, Турция (Туркие), 35540
- Рекрутинг
- İzmir City Hospital
-
Контакт:
- Murat KAYKAC, M.D.
- Номер телефона: +905330258450
- Электронная почта: mrtkykc@gmail.com
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Children aged 2 to 6 years.
- Scheduled to undergo an elective surgical procedure.
- Scheduled to undergo surgery under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Able to communicate in Turkish and understand verbal instructions.
- Written informed consent obtained from a parent or legal guardian.
- No pharmacological premedication planned during the preoperative period.
- No serious systemic disease and no use of sedative or psychotropic medication
Exclusion Criteria:
- History of neurodevelopmental delay, psychiatric illness, or a significant behavioral disorder.
- Significant visual or hearing impairment that limits communication.
- Use of sedative, hypnotic, or psychotropic medication within the previous 2 weeks.
- Requirement for pharmacological premedication or additional sedation during the intraoperative period.
- Serious systemic disease or ASA physical status III or higher.
- A protocol deviation during anesthesia or surgery, including complications or cancellation of surgery.
- Inability to obtain written informed consent from a parent or legal guardian.
- Inability to comply with the assigned intervention or inability to complete the video-based i
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Live Parent-Child Video Interaction
Participants assigned to this arm will receive live parent-child video interaction using a tablet during transfer to the operating room.
The intervention will end immediately before anesthesia induction.
Participants will otherwise receive routine perioperative care.
|
During transfer to the operating room, the child will have live video communication with a parent using a tablet.
The tablet will be positioned so that only the child's face is visible and the operating room environment is not included in the camera view.
Audio will be transmitted from the parent to the child, with no audio transmitted from the operating room.
The session will not be recorded and will end immediately before the start of anesthesia induction.
|
|
Экспериментальный: Cartoon Watching
Participants assigned to this arm will watch an age-appropriate cartoon on a tablet during transfer to the operating room.
Cartoon viewing will end immediately before anesthesia induction.
Participants will otherwise receive routine perioperative care.
|
During transfer to the operating room, the child will watch a short, age-appropriate cartoon on a tablet.
The cartoon will be a 3- to 5-minute animation without violent or frightening content.
The content will be preloaded on the tablet and will not require an internet connection.
No audio or video recording will be made.
Cartoon viewing will end immediately before the start of anesthesia induction.
|
|
Без вмешательства: Standard Care
Participants assigned to this arm will receive routine perioperative care without a study-specific video-based distraction intervention.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Maximum Pediatric Anesthesia Emergence Delirium Scale Score
Временное ограничение: From admission to discharge from the post-anesthesia care unit on the day of surgery
|
Emergence agitation will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.
The PAED scale consists of five observational items and has a total score ranging from 0 to 20, with higher scores indicating more severe emergence delirium.
The highest PAED score observed during the participant's stay in the post-anesthesia care unit will be used for analysis.
|
From admission to discharge from the post-anesthesia care unit on the day of surgery
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Preoperative Anxiety Score at Parent Separation
Временное ограничение: At parent separation on the day of surgery
|
The child's preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF) at the time of parent separation.
The total score ranges from 22.92 to 100, with higher scores indicating greater preoperative anxiety.
|
At parent separation on the day of surgery
|
|
Preoperative Anxiety Score at the Start of Anesthesia Induction
Временное ограничение: At the start of anesthesia induction on the day of surgery
|
The child's preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF) at the beginning of anesthesia induction.
The total score ranges from 22.92 to 100, with higher scores indicating greater preoperative anxiety.
|
At the start of anesthesia induction on the day of surgery
|
|
Parental State Anxiety Score Before the Intervention
Временное ограничение: At the preoperative visit before the study intervention
|
Parental state anxiety will be assessed using the State-Trait Anxiety Inventory-State Form (STAI-S).
The STAI-S is a 20-item self-report measure with a total score ranging from 20 to 80, with higher scores indicating greater state anxiety.
|
At the preoperative visit before the study intervention
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of Participants With Emergence Agitation
Временное ограничение: From admission to discharge from the post-anesthesia care unit on the day of surgery
|
Emergence agitation will be defined as a maximum Pediatric Anesthesia Emergence Delirium (PAED) scale score of 10 or greater during the post-anesthesia care unit stay.
The number and percentage of participants meeting this criterion will be compared among the three study groups.
|
From admission to discharge from the post-anesthesia care unit on the day of surgery
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026/4
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .