Actively Recruiting

Phase Not Applicable
Age: 2Years - 6Years
All Genders
Healthy Volunteers
ID07230743

Comparison of Anxiety During Mask Induction of Anesthesia in Children Using an Interactive Projector Video Game Versus Standard Parent-Present Care

Led by Clinica Alemana de Santiago · Updated on 2025-11-17

70

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

C

Clinica Alemana de Santiago

Lead Sponsor

U

Universidad del Desarrollo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how the use of an interactive projector-based video game as a distraction during anesthetic mask induction affects anxiety levels in children aged 2 to 6 years. The study focuses on perioperative anxiety measured by the Modified Yale Preoperative Anxiety Scale (mYPAS) and compares this technology intervention with standard care. It is a randomized, controlled, open-label clinical trial conducted in a Latin American setting. Participants are randomly assigned to one of two groups: one receiving routine mask induction with a parent present and no additional distraction, and the other receiving the same parent-present induction along with the interactive video game projected in front of the child. The projection is designed to engage children from their arrival in the operating room throughout the induction process, and the intervention ends when the child loses consciousness and standard care resumes. During the study, researchers will observe and measure the child's anxiety, cooperation, compliance, and caregiver satisfaction during and after anesthetic induction. Additional assessments include behavioral outcomes two weeks after surgery and correlations with physiological measures at mask application. The study includes setup and operation of the projection system by research staff, and participants will be monitored throughout the perioperative period. Total participation includes the induction phase and follow-up assessments after surgery.

CONDITIONS

Brief Title

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).

Who Can Participate

Age: 2Years - 6Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective procedures under general anesthesia at Clinica Alemana
  • Parent or caregiver present during mask induction
  • ASA physical status I or II
  • Age between 2 and 6 years
  • Spanish speaking
  • Parental consent and patient assent obtained
Not Eligible

You will not qualify if you...

  • Patient or parent does not consent
  • ASA physical status III or higher
  • Emergency surgery
  • Intravenous induction of anesthesia
  • Significant neurological condition or major developmental disability
  • Severe visual or hearing impairments
  • Use of a crib as transport to the operating room

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single anesthetic induction day

Participants undergo mask induction of anesthesia accompanied by a parent. Those in the Technology Intervention group will engage with a custom projector-based video game during induction to reduce anxiety, while the Standard Parent-Present Induction group receives routine care without additional distraction.

1 visit (in-person)

Follow-up

Duration - 2 weeks after surgery

Participants are observed for long-term behavioral outcomes and caregiver satisfaction after anesthetic induction and surgery.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Clínica Alemana de Santiago

Vitacura, Santiago Metropolitan, Chile, 7630000

Actively Recruiting

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Research Team

X

Ximena Mora Diez, MD

R

Rodrigo Guiloff Krauss, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery.

Brooke N Jenkins, Zeev N Kain, Sherrie H Kaplan...

https://pubmed.ncbi.nlm.nih.gov/25958978

Varying screen size for passive video distraction during induction of anesthesia in low-risk children: A pilot randomized controlled trial.

Samuel T Rodriguez, Olivia Jang, Jessica Maya Hernandez...

https://pubmed.ncbi.nlm.nih.gov/30916447

Transcultural adaptation into Spanish of the Induction Compliance Checklist for assessing children's behaviour during induction of anaesthesia.

Carmen Jerez-Molina, Juan J Lázaro-Alcay, Ana M Ullán-de la Fuente

https://pubmed.ncbi.nlm.nih.gov/29054560

Comparison of different scales for the evaluation of anxiety and compliance with anesthetic induction in children undergoing scheduled major outpatient surgery.

Alberto Vieco-García, Amanda López-Picado, Manuel Fuentes...

https://pubmed.ncbi.nlm.nih.gov/34903293