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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
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.
Participants in the Standard PPI group will undergo routine mask induction of anesthesia accompanied by a parent, with no additional structured distraction.
Clínica Alemana de Santiago
Vitacura, Santiago Metropolitan, Chile
RECRUITINGPediatric 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
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
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
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
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
Correlation to HRAD+/- to mYPAS
To measure correlation of HRAD+/- to mYPAS
Time frame: Single time point at mask application during anesthetic induction (Day 0, intraoperative)
Correlation to HRAD+/- to ICC
To measure correlation of the cooperation component of HRAD+/- to ICC
Time frame: Single time point at mask application during anesthetic induction (Day 0, intraoperative).
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