Live Parent-Child Video Interaction and Cartoon Watching for Emergence Agitation in Children

Официальное название

The Effect of Live Video Parent-Child Interaction and Cartoon Watching on Emergence Agitation in Children Aged 2-6 Years: A Randomized Controlled Trial

Обзор

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.

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.

Вмешательства

• Поведенческое Live Parent-Child Video Interaction
  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.
• Поведенческое Cartoon Watching
  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.

Первичные конечные точки

• Maximum Pediatric Anesthesia Emergence Delirium Scale Score [Срок оценки: From admission to discharge from the post-anesthesia care unit on the day of surgery]

Вторичные конечные точки (3)

• Preoperative Anxiety Score at Parent Separation [Срок оценки: At parent separation on the day of surgery]
• Preoperative Anxiety Score at the Start of Anesthesia Induction [Срок оценки: At the start of anesthesia induction on the day of surgery]
• Parental State Anxiety Score Before the Intervention [Срок оценки: At the preoperative visit before the study intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Izmir City Hospital — Izmir

Идентификаторы

NCT: NCT07689305 · 2026/4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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