Emergence DeliriumLIVE-CART KidsNCT07689305
Live Parent-Child Video Interaction and Cartoon Watching for Emergence Agitation in Children
A study testing Live Parent-Child Video Interaction and Cartoon Watching in people with Emergence Delirium and Preoperative Anxiety, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Emergence Delirium, Preoperative Anxiety
- What is being tested?
- Live Parent-Child Video Interaction and Cartoon Watching
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Izmir City Hospital
Izmir, İzmir, 35540
Murat KAYKAC, M.D., +905330258450, mrtkykc@gmail.com
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Emergence Delirium, Preoperative Anxiety
- Being tested
- Live Parent-Child Video Interaction, Cartoon Watching
- Keywords
- Emergence Agitation, Pediatric Anesthesia, mYPAS-SF, PAED Scale, Preschool Children, Cartoon Watching, Live Parent-Child Video Interaction, Video Distraction, Preoperative Anxiety
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Parent-Child Video InteractionBehavioural
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.
Cartoon WatchingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Live Parent-Child Video Interaction |
| 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. Receives: Behavioral: Cartoon Watching |
| Standard Care | No intervention | Participants assigned to this arm will receive routine perioperative care without a study-specific video-based distraction intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission to discharge from the post-anesthesia care unit on the day of surgery
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At the preoperative visit before the study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start15 Feb 2026
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Murat Kaykaç, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689305
- Sponsor's protocol ID
- 2026/4
- Acronym
- LIVE-CART Kids
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Live Video Parent-Child Interaction and Cartoon Watching on Emergence Agitation in Children Aged 2-6 Years: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07689305
- Acronym / sponsor ID
- LIVE-CART Kids / 2026/4
- Conditions
- Emergence Delirium, Preoperative Anxiety
- Keywords
- Emergence Agitation, Pediatric Anesthesia, mYPAS-SF, PAED Scale, Preschool Children, Cartoon Watching, Live Parent-Child Video Interaction, Video Distraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Izmir City HospitalOther government
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Live Parent-Child Video Interaction | Experimental | Behavioral: Live Parent-Child Video InteractionParticipants 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 | Behavioral: Cartoon WatchingParticipants 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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Parent-Child Video InteractionDuring 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. | Behavioural | Live Parent-Child Video Interaction |
| Cartoon WatchingDuring 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. | Behavioural | Cartoon Watching |
Primary outcome
Maximum Pediatric Anesthesia Emergence Delirium Scale Score
Time frame: 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.
3 secondary outcomes
Preoperative Anxiety Score at Parent Separation
Time frame: At parent separation on the day of surgery
Preoperative Anxiety Score at the Start of Anesthesia Induction
Time frame: At the start of anesthesia induction on the day of surgery
Parental State Anxiety Score Before the Intervention
Time frame: At the preoperative visit before the study intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Parent-Child Video Interaction and Cartoon Watching in people with Emergence Delirium and Preoperative Anxiety, run by Izmir City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Murat KAYKAC, M.D. (+905330258450, mrtkykc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Pediatric Anesthesia Emergence Delirium Scale Score (time frame: From admission to discharge from the post-anesthesia care unit on the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.