A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education

Completed · Not applicable

Conditions studied: Anesthesia, Anesthesia Emergence Delirium, Procedural Anxiety

In brief

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.

Key facts

Study ID: NCT04586569
Run by: Boston Children's Hospital
People needed: 76
Starts: 2021-07-06
Expected to finish: 2023-10-19
Last updated by the study team: 2025-11-04

Who can join

Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Boston Children's Hospital — Waltham, Massachusetts, United States

Full record on ClinicalTrials.gov

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