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NCT Number: NCT07230743

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).

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).

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Key information

Conditions

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

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Alemana de Santiago

Vitacura, Santiago Metropolitan, 7630000, Chile

Location status: Recruiting

Location contact

Ximena Mora Diez, MD

CONTACT

[email protected]

+56995377637

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: BERT

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rodrigo Guiloff Krauss, MD

CONTACT

[email protected]

56 222101111 ext. 6223

Ximena Mora Diez, MD

CONTACT

[email protected]

+569 95377637

Sponsors and collaborators

Lead sponsor

Clinica Alemana de Santiago

Other

Collaborators

  • Universidad del Desarrollo

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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