N/A
Completed N=76
A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education
Anesthesia · Anesthesia Emergence Delirium · Procedural Anxiety
Source: ClinicalTrials.gov NCT04586569 ↗
Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety — 25; 25 score on a scale
Summary
The purpose of this study is to determine the efficacy of enhanced preoperative education using a Pediatric Interactive Relational Agent (PIRA), designed for children aged 4 through 10 years and their families, compared to the standard preoperative education currently provided. Specifically, the study aimed to evaluate differences in parent/child preoperative anxiety, and child experience with emergence from anesthesia. A secondary aim was to evaluate the child's and the parent's access and utilization the Pediatric Interactive Relational Agent as well as parental satisfaction and difficulties with the tool.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety |
25; 25 | — |
| PRIMARY Parental Anxiety in Preoperative Waiting Room Using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety |
46; 48 | — |
| PRIMARY Emergence From Anesthesia: Presence or Absence of Emergence Agitation/Delirium (ED) Using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia Scale |
3; 4 | — |
| SECONDARY Parental Perceived Impact and Impressions Assessed Through the Parental PIRA Survey |
— | — |
| SECONDARY Parental Utilization |
— | — |
Eligibility Criteria
Inclusion Criteria
- Parents (age 18+) and their children, ages 4 through 10 years old, who are undergoing general anesthesia and elective, outpatient ORL surgery at BCH Waltham
- American Society of Anesthesiology (ASA) physical status I or II
- Both parents and their children must be fluent in English
Exclusion Criteria
- Parents without reliable internet access through a tablet or computer
- Parents of children with diagnosed developmental delays
- Parents who have children who have had previous surgical history under general anesthesia
- Parents of children involved in other anesthesia-related studies at BCH
Data sourced from ClinicalTrials.gov (NCT04586569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.