The Effect of Live Video Parent-Child Interaction and Cartoon Watching on Emergence Agitation in Children Aged 2-6 Years: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Maximum Pediatric Anesthesia Emergence Delirium Scale Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the interventions, participants, parents, care providers, and investigators involved in intervention delivery cannot be masked. Outcome assessments will be performed by an observer who is not involved in randomization or intervention delivery and who will not be informed of group allocation. The assessor evaluating PAED scores in the post-anesthesia care unit will assess the child after the video-based intervention has ended.
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Cartoon Watching (Behavioral)
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.
干预措施: Live Parent-Child Video Interaction (Behavioral)
Standard Care
Participants assigned to this arm will receive routine perioperative care without a study-specific video-based distraction intervention.
结局指标
主要结局
Maximum Pediatric Anesthesia Emergence Delirium Scale Score
时间窗: 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.
次要结局
- Preoperative Anxiety Score at Parent Separation(At parent separation on the day of surgery)
- Preoperative Anxiety Score at the Start of Anesthesia Induction(At the start of anesthesia induction on the day of surgery)
- Parental State Anxiety Score Before the Intervention(At the preoperative visit before the study intervention)
研究者
Murat Kaykaç
Anesthesiology and Reanimation Specialist, MD
Izmir City Hospital