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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).

ConditionsAnxietyAnxiety After SurgeryInduction of AnesthesiaAnxiety PreoperativeAnesthesia CareTechnology UseChild Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-6
SponsorClinica Alemana de Santiago

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patient or parental does not consent

ASA ≥ III

Emergency surgery

Intravenous induction of anesthesia

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard Parent-Present Induction (PPI)

    Other intervention

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Standard Parent-Present Induction (PPI)Active comparator 1 intervention
Group B: Technology Intervention groupExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
Perioperative/anesthetic induction

Secondary outcomes

1

Affect and Cooperation

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.

Time frame
Perioperative/anesthetic induction
2

Compliance

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.

Time frame
Perioperative/anesthetic induction
3

Caregiver Satisfaction With the Induction Experience

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.

Time frame
Perioperative/after anesthetic induction
4

Long-term behavioral outcomes

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).

Time frame
2 weeks after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinica Alemana de Santiago

Lead sponsor

Universidad del Desarrollo

Collaborator

Source ClinicalTrials.gov
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