PIRA vs Standard Preoperative Education

A Pilot Randomized Control Trial Testing the Acceptability and Feasibility of a Pediatric Interactive Relational Agent (PIRA) vs. Standard Preoperative Education

The purpose of this study is to determine the feasibility and acceptability of enhanced preoperative education using a Pediatric Interactive Relational Agent (PIRA), designed for children ages 4 through10 years and their families, compared to the standard preoperative education currently provided. The study will also look at any differences in anxiety between the two educational groups.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Procedural Anxiety; Anesthesia Emergence Delirium
• Intervention / Treatment: Other: Pediatric Interactive Relational Agent (PIRA)

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda Bulich, MD; Phone Number: 617-355-7737; Email: linda.bulich@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02453
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Education; This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.
Experimental: Pediatric Interactive Relational Agent (PIRA); This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham and will be given access to an interactive, online educational tool for use prior to surgery. This Pediatric Interactive Relational Agent (PIRA) will be able to be accessed as many times as the family would like prior to surgery.	Other: Pediatric Interactive Relational Agent (PIRA); The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Utilization	Interested in whether or not parents use the PIRA, frequency and duration of use, and whether or not there were any barriers to its use. This will be assessed through the Parental PIRA Survey.	2-10 days
Parental Perceived Impact and Impressions assessed through the Parental PIRA Survey	This survey assesses parental opinions about the PIRA.	preoperative period - 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Anxiety in Preoperative Waiting using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety	This observational tool will be used to determine if there a difference in anxiety between children who got the PIRA and those in the control group. It will look at the incidence and severity of anxiety in children who received the PIRA vs. those who received the standard education.	preoperative period - 1 day
Parental Anxiety in Preoperative Waiting using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety	This survey will be used to determine if there a difference in anxiety between the parents who got the PIRA and those in the control group. It will look at the incidence and severity of anxiety in families who received the PIRA vs. those that received the standard education.	preoperative period- 1 day
Emergence from Anesthesia: Presence or absence of emergence agitation/delirium (ED) using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia scale	This observational tool is used to determine if there is any effect on the incidence of ED for children who have more interactive preoperative education, such as PIRA, compared to standard information.	immediately postop - 1 day

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Northeastern University
• Investigators: Principal Investigator: Linda Bulich, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): October 19, 2023

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: education
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: P00035987

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No