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).

NCT07230743 | Recruiting

• 1 other identifier: ID 1483
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Custom Projector-based Software Game; Pediatric Mask Induction Anxiety

Outcome Measures

Primary Outcomes (1)

• Pediatric anxiety

  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 Outcomes (6)

• Affect and Cooperation

  Perioperative/anesthetic induction

• Compliance

  Perioperative/anesthetic induction

• Caregiver Satisfaction With the Induction Experience

  Perioperative/after anesthetic induction

• Long-term behavioral outcomes

  2 weeks after surgery

• Correlation to HRAD+/- to mYPAS

  Single time point at mask application during anesthetic induction (Day 0, intraoperative)

Study Arms (2)

Standard Parent-Present Induction (PPI)

ACTIVE COMPARATOR

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)

Technology Intervention group

EXPERIMENTAL

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.

Device: Custom projector-based video game intervention (BERT; Stanford Chariot Program, Palo Alto, CA); Other: Standard Parent-Present Induction (PPI)

Interventions

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

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.

Also known as: BERT

Technology Intervention group

Standard Parent-Present Induction (PPI) OTHER

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

Standard Parent-Present Induction (PPI); Technology Intervention group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinica Alemana de Santiago: lead
• Universidad del Desarrollo: collaborator

Study Sites (1)

Clínica Alemana de Santiago

Vitacura, Santiago Metropolitan, 7630000, Chile

RECRUITING

Related Publications (10)

• Jenkins BN, Kain ZN, Kaplan SH, Stevenson RS, Mayes LC, Guadarrama J, Fortier MA. Revisiting a measure of child postoperative recovery: development of the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery. Paediatr Anaesth. 2015 Jul;25(7):738-45. doi: 10.1111/pan.12678. Epub 2015 May 9.

  PMID: 25958978 BACKGROUND

• Rodriguez ST, Jang O, Hernandez JM, George AJ, Caruso TJ, Simons LE. Varying screen size for passive video distraction during induction of anesthesia in low-risk children: A pilot randomized controlled trial. Paediatr Anaesth. 2019 Jun;29(6):648-655. doi: 10.1111/pan.13636. Epub 2019 Apr 14.

  PMID: 30916447 BACKGROUND

• Fefferman MS, Fraser AE, Takemoto CM, Menendez A, Graetz TJ, Beres AL. Prospective, observational validation of HRAD±, a novel pediatric affect and cooperation scale. Paediatric Anaesthesia. 2024;34(4):376-384.

  BACKGROUND

• Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.

  PMID: 9322455 BACKGROUND

• Jerez-Molina C, Lázaro-Alcay JJ, Ullán-de la Fuente AM. Adaptación transcultural al español de la Induction Compliance Checklist para evaluar el comportamiento infantil durante la inducción anestésica. Enfermería Clínica (English Edition). 2017;27(5):271-276.

  BACKGROUND

• Jerez C, Ullan AM, Lazaro JJ. Reliability and validity of the Spanish version of the modified Yale Preoperative Anxiety Scale. Rev Esp Anestesiol Reanim. 2016 Jun-Jul;63(6):320-6. doi: 10.1016/j.redar.2015.09.006. Epub 2015 Nov 26. English, Spanish.

  PMID: 26633606 BACKGROUND

• Yun R, Caruso TJ. Identification and Treatment of Pediatric Perioperative Anxiety. Anesthesiology. 2024 Nov 1;141(5):973-983. doi: 10.1097/ALN.0000000000005105. No abstract available.

  PMID: 39163600 BACKGROUND

• Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.

  PMID: 15562048 BACKGROUND

• Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.

  PMID: 16882820 BACKGROUND

• Vieco-Garcia A, Lopez-Picado A, Fuentes M, Francisco-Gonzalez L, Joyanes B, Soto C, Garcia de la Aldea A, Gonzalez-Perrino C, Aleo E. Comparison of different scales for the evaluation of anxiety and compliance with anesthetic induction in children undergoing scheduled major outpatient surgery. Perioper Med (Lond). 2021 Dec 14;10(1):58. doi: 10.1186/s13741-021-00228-x.

  PMID: 34903293 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Ximena Mora Diez, MD

CONTACT

+569 95377637; xmora@alemana.cl

Rodrigo Guiloff Krauss, MD

CONTACT

56 222101111; rguilofk@udd.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, caregivers, and clinical staff (anesthesia/OR teams) are not masked. Outcome assessors who score mYPAS, HRAD+/-, and ICC from video recordings are masked to group assignment: recordings are framed to exclude any view of the projection/screen and audio cues are removed; raters receive only a study ID and time point. The data team/statistical analysts remain masked until the analysis plan is finalized and the database is locked. The allocation sequence is concealed within REDCap and is revealed to implementers only at the time of induction. Unmasking of raters or analysts will occur only for prespecified safety reviews or after database lock. Inter-rater agreement (intraclass correlation) will be monitored to ensure the quality of masked assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm, parallel-group superiority trial with 1:1 individual randomization to BERT (a non-pharmacologic audiovisual projection during anesthetic induction) or usual care without BERT. The randomization sequence is created and implemented in REDCap, and group assignment remains concealed until setup in the operating room. The study is open-label-families and clinical staff can tell whether the projection is used-while data analysis is performed by team members who are not involved in delivering the intervention. Enrollment takes place at a single site (Ambulatory Pediatric Surgery Unit, Clínica Alemana de Santiago, Chile). Eligible participants are children 2-6 years scheduled for elective adenotonsillar surgery under general anesthesia. A caregiver is present in both arms. Outcomes are collected during induction on Day 0; caregivers are contacted again 14 days after surgery to complete the PHBQ-AS.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: November 17, 2025
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)