PIRA vs Standard Preoperative Education

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04586569
• Other study ID #: P00035987
• Status: Completed
• Phase: N/A
• Start date: July 6, 2021
• Est. completion date: October 19, 2023

Study information

• Verified date: November 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: October 19, 2023
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia Emergence Delirium
• Emergence Delirium
• Procedural Anxiety

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Waltham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	Northeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Parental Perceived Impact and Impressions assessed through the Parental PIRA Survey	This survey assesses parental opinions about the PIRA.	preoperative period - 1 day
Secondary	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
Secondary	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
Secondary	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