NCT07689305

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Feb 2026Aug 2026

Study Start

First participant enrolled

February 15, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 1, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

Emergence AgitationPediatric AnesthesiamYPAS-SFPAED ScalePreschool ChildrenCartoon WatchingLive Parent-Child Video InteractionVideo DistractionPreoperative Anxiety

Outcome Measures

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.

    From admission to discharge from the post-anesthesia care unit on the day of surgery

Secondary Outcomes (3)

  • Preoperative Anxiety Score at Parent Separation

    At parent separation on the day of surgery

  • Preoperative Anxiety Score at the Start of Anesthesia Induction

    At the start of anesthesia induction on the day of surgery

  • Parental State Anxiety Score Before the Intervention

    At the preoperative visit before the study intervention

Other Outcomes (1)

  • Number of Participants With Emergence Agitation

    From admission to discharge from the post-anesthesia care unit on the day of surgery

Study Arms (3)

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.

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.

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.

Interventions

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.

Cartoon Watching

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.

Live Parent-Child Video Interaction

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir City Hospital

Izmir, İzmir, 35540, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Murat KAYKAC, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist, MD

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 8, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations