Overview
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).
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.
Eligibility
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