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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Live Parent-Child Video Interaction | Experimental | 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. |
|
| Cartoon Watching | Experimental | 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. |
|
| Standard Care | No Intervention | Participants assigned to this arm will receive routine perioperative care without a study-specific video-based distraction intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Parent-Child Video Interaction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Pediatric Anesthesia Emergence Delirium Scale Score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Anxiety Score at Parent Separation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Emergence Agitation | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Murat KAYKAC, M.D. | Contact | +905330258450 | mrtkykc@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir City Hospital | Recruiting | Izmir | İzmir | 35540 | Turkey (Türkiye) |
Individual participant-level data are not planned to be shared. Only aggregated and de-identified study results will be reported in scientific publications and the clinical trial registry.
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Participants will be randomized in a 1:1:1 ratio to live parent-child video interaction, age-appropriate cartoon watching, or standard care. Each participant will remain in the assigned group throughout the perioperative study period.
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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.
|
| Cartoon Watching | Behavioral | 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. |
|
| Preoperative Anxiety Score at the Start of Anesthesia Induction | 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 | 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 |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |