N/A
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
Bottom Line
View on ClinicalTrials.gov: NCT04586569 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety — 25; 25 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pediatric Interactive Relational Agent (PIRA) (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Oct 2023
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 |
— | — |
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.
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.