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).

November 13, 2025 updated by: Clinica Alemana de Santiago

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, controlled, open-label, parallel-assignment clinical trial designed to evaluate the effect of a non-pharmacologic technological intervention (projected video game) on perioperative anxiety in children during anesthetic induction.

Study type: Prospective, comparative clinical trial. Randomization: Simple randomization in a 1:1 ratio using an electronic sequence generated and administered in REDCap®.

Masking: Open-label (no blinding), as healthcare staff, caregivers, and patients can identify the presence or absence of the projected video game during induction. However, statistical analyses will be performed by investigators who did not take part in the intervention's implementation, in order to minimize bias.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ximena Mora Diez, MD
  • Phone Number: +569 95377637
  • Email: xmora@alemana.cl

Study Contact Backup

  • Name: Rodrigo Guiloff Krauss, MD
  • Phone Number: 6223 56 222101111
  • Email: rguilofk@udd.cl

Study Locations

  • Chile
    • Santiago Metropolitan
      • Vitacura, Santiago Metropolitan, Chile, 7630000
        • Recruiting
        • Clinica Alemana de Santiago
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard 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.
Other: Standard 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.
Experimental: Technology Intervention group
Participants in the Technology Intervention group will receive the same parent-present induction, with the addition of a custom 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.
Other: Standard 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.
Device: Custom 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.

Other Names:
  • BERT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric anxiety
Time Frame: Perioperative/anesthetic induction
Pediatric anxiety levels during mask induction as measured through the Modified Yale Preoperative Anxiety Scale (mYPAS). The Modified Yale Preoperative Anxiety Scale (mYPAS) is a 22-item checklist divided into five categories: "activity," "vocalization," "emotional expressiveness," "apparent arousal," and "relationship with parents." Each category consists of a list of interrelated behaviors, the most representative of which is the score for that category. The mYPAS score ranges from 23.3 to 100; the threshold for considering patients with anxiety is > 30.
Perioperative/anesthetic induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Affect and Cooperation
Time Frame: Perioperative/anesthetic induction
To measure patient affect and cooperation during mask induction, measured by HRAD +/- scale. The Happy, Relaxed, Anxious, Distressed with a yes/no measure of cooperation (HRAD ±) is an observational affect scale developed to clinically assess affect and cooperation during inhalational induction and minor procedures.
Perioperative/anesthetic induction
Compliance
Time Frame: Perioperative/anesthetic induction
To measure cooperation and compliance during mask induction, with the ICC (Induction Compliance Checklist). This scale contains a list of 11 behaviors that the child may exhibit when the face mask is placed near them during induction. The score ranges from 0 to 10, with 0 indicating that the child cooperates and shows no mask-rejecting behaviors, and 10 indicating the worst expected response. The higher the score on the ICC scale, the greater the child's rejection of the surgical mask. The authors recommended that a score of 6 or higher be considered traumatic anesthesia.
Perioperative/anesthetic induction
Caregiver Satisfaction With the Induction Experience
Time Frame: Perioperative/after anesthetic induction
To assess caregiver satisfaction regarding the projector-based software program for mask induction, measured by Parent Satisfaction Survey. This survey consists of a score from 0 to 5; from 0 = very unsatisfied to 5 = very satisfied.
Perioperative/after anesthetic induction
Long-term behavioral outcomes
Time Frame: 2 weeks after surgery
To measure incidence of postoperative behavioral outcomes after anesthesia event, measured by Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). The PHBQ is comprised of 27 items among six subscales (general anxiety and regression, separation anxiety, eating disturbance, aggression toward authority, apathy/withdrawal, anxiety about sleep). This method produces a possible range of scores from 27 - 135 (with with higher scores, worse outcomes).
2 weeks after surgery
Correlation to HRAD+/- to mYPAS
Time Frame: Single time point at mask application during anesthetic induction (Day 0, intraoperative)
To measure correlation of HRAD+/- to mYPAS
Single time point at mask application during anesthetic induction (Day 0, intraoperative)
Correlation to HRAD+/- to ICC
Time Frame: Single time point at mask application during anesthetic induction (Day 0, intraoperative).
To measure correlation of the cooperation component of HRAD+/- to ICC
Single time point at mask application during anesthetic induction (Day 0, intraoperative).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Alemana de Santiago

Collaborators

Universidad del Desarrollo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

September 8, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Actual)

November 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 1483

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared. Given the pediatric, single-center design and small sample size, the risk of re-identification remains non-trivial even after de-identification. In addition, our consent forms do not explicitly authorize external IPD sharing. We will share aggregate numerical results only (e.g., group means, SDs, effect sizes, confidence intervals) in publications and on ClinicalTrials.gov, and provide the protocol and SAP upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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