RecruitingNot ApplicableNCT07230743

The Study Evaluates the Effect of an Interactive Projector as a Distraction for Children During Anesthetic Induction. The Primary Objective is to Reduce Perioperative Anxiety, Measured With the Modified Yale Preoperative Anxiety Scale (mYPAS).

Comparison of Anxiety During Mask Induction of Anesthesia in Pediatric Patients With an Immersive/Interactive Technological Intervention Versus Traditional Care: A Latin American Experience

Sponsor

Clinica Alemana de Santiago

Enrollment

70 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Child Anxiety Anxiety Preoperative Anxiety After Surgery Induction of Anesthesia Anesthesia Care Technology Use

Summary

This study is designed to evaluate the effect of technology as a distraction technique during anesthetic induction in children, starting from their arrival to the operating room. An interactive film will be displayed using a projector (BERT: Bedside Entertaining and Relaxation Tool) mounted on a whiteboard in front of the child's gurney. The primary outcome is perioperative anxiety, measured with the Modified Yale Preoperative Anxiety Scale (mYPAS).

Eligibility

Min Age: 2 YearsMax Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using an interactive projector as a distraction can reduce anxiety in young children (ages 2–6) during the process of going under general anesthesia. The projector displays engaging visuals to help calm children before surgery. **You may be eligible if...** - Your child is between 2 and 6 years old - Your child is having a planned (non-emergency) procedure under general anesthesia - Your child is in good to average health (ASA class I or II) - A parent or caregiver will be present during the anesthesia induction (mask process) - Your child speaks Spanish **You may NOT be eligible if...** - You (the parent/guardian) do not consent to participation - Your child has a serious neurological condition or major developmental disability - Your child has severe vision or hearing problems - Your child needs emergency surgery - Your child requires intravenous (IV) rather than mask anesthesia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECustom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA)

The interactive audiovisual content is displayed on a large projection screen strategically placed at the foot of the operating table to ensure optimal visibility for the pediatric patient. Children will be instructed to watch and engage with the content as they enter the operating room and throughout the induction process. The intervention is designed to promote engagement and reduce perioperative anxiety. Research assistants will set up and operate the projection system and ensure appropriate timing and delivery. Caregivers and OR personnel will be permitted to interact with the child as usual during induction. The video intervention concludes upon loss of consciousness, at which point standard perioperative care resumes.

OTHERStandard Parent-Present Induction (PPI)

Participants in the Standard PPI group will undergo routine mask induction of anesthesia accompanied by a parent, with no additional structured distraction.