Live Parent-Child Video Interaction and Cartoon Watching for Emergence Agitation in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-6
SponsorIzmir City Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Live Parent-Child Video Interaction
BehavioralDuring 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.
Cartoon Watching
BehavioralDuring 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.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Live Parent-Child Video InteractionExperimental treatment 1 intervention
Group B: Cartoon WatchingExperimental treatment 1 intervention
Group C: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 interventionOther outcomes
1
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 surgerySponsors and contacts
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Source ClinicalTrials.gov