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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Murat KAYKAC, M.D.
- 電話番号：+905330258450
- メール：mrtkykc@gmail.com
研究場所
-
-
İzmir
-
Izmir、İzmir、トルコ（Türkiye）、35540
- 募集
- İzmir City Hospital
-
コンタクト：
- Murat KAYKAC, M.D.
- 電話番号：+905330258450
- メール：mrtkykc@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
介入なし：Standard Care
Participants assigned to this arm will receive routine perioperative care without a study-specific video-based distraction intervention.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum Pediatric Anesthesia Emergence Delirium Scale Score
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Preoperative Anxiety Score at Parent Separation
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants With Emergence Agitation
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026/4
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。