Anesthesia Care, Anxiety, Anxiety After Surgery, Anxiety Preoperative, Child Anxiety, Induction of Anesthesia, Technology Use
Conditions
Keywords
Custom Projector-based Software Game, Pediatric Mask Induction Anxiety
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).
Detailed 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.
Interventions
DEVICECustom 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. 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.
OTHERStandard Parent-Present Induction (PPI)
Participants in the Standard PPI group will undergo routine mask induction of anesthesia accompanied by a parent, with no additional structured distraction.
Sponsors
Universidad del Desarrollo
Clinica Alemana de Santiago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric anxiety | 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
| Measure | Time frame | Description |
|---|---|---|
| Compliance | 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. |
| Caregiver Satisfaction With the Induction Experience | 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. |
| Affect and Cooperation | 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. |
| Correlation to HRAD+/- to mYPAS | Single time point at mask application during anesthetic induction (Day 0, intraoperative) | To measure correlation of HRAD+/- to mYPAS |
| Correlation to HRAD+/- to ICC | Single time point at mask application during anesthetic induction (Day 0, intraoperative). | To measure correlation of the cooperation component of HRAD+/- to ICC |
| Long-term behavioral outcomes | 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). |
Countries
Chile
Contacts
Primary ContactXimena Mora Diez, MD
Backup ContactRodrigo Guiloff Krauss, MD
Outcome results
None listed