An interventional study of Live Parent-Child Video Interaction and Cartoon Watching in Emergence Delirium and Preoperative Anxiety, sponsored by Izmir City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Izmir City Hospital · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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.
Behavioral: Live Parent-Child Video Interaction
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.
Behavioral: Cartoon Watching
Participants assigned to this arm will receive routine perioperative care without a study-specific video-based distraction intervention.
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.
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.
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.
Time frame: From admission to discharge from the post-anesthesia care unit on the day of surgery
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.
Time frame: At parent separation on the day of surgery
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.
Time frame: 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.
Time frame: At the preoperative visit before the study intervention
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.
Time frame: From admission to discharge from the post-anesthesia care unit on the day of surgery
Plan to share: No — 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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Izmir City Hospital