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

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

Inclusion Criteria6

  • Patients undergoing elective procedures under general anesthesia at Clinica Alemana
  • Parent or caregiver presence for mask induction
  • ASA I, II
  • Ages 2-6 years of age
  • Spanish speaking
  • Parental consent/patient assent

Exclusion Criteria7

  • Patient or parental does not consent
  • ASA ≥ III
  • Emergency surgery
  • Intravenous induction of anesthesia
  • Patient with a significant neurological condition or major developmental disability
  • Severe visual or auditory defects
  • Patients admitted using a crib as the mode of transport

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.


Locations(1)

Clínica Alemana de Santiago

Vitacura, Santiago Metropolitan, Chile

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NCT07230743


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