PIRA vs Standard Preoperative Education

Not Applicable

Completed

• Conditions: Anesthesia; Anesthesia Emergence Delirium; Procedural Anxiety

• Registration Number: NCT04586569
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Study Start: 2021-07-06
• Status Verified: 2022-11
• Primary Completion: 2023-10-19
• Study Completion: 2023-10-19
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Parental Perceived Impact and Impressions assessed through the Parental PIRA Survey	preoperative period - 1 day	This survey assesses parental opinions about the PIRA.
Parental Utilization	2-10 days	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.

Secondary Outcome Measures

Name	Time	Method
Child Anxiety in Preoperative Waiting using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety	preoperative period - 1 day	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.
Emergence from Anesthesia: Presence or absence of emergence agitation/delirium (ED) using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia scale	immediately postop - 1 day	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.
Parental Anxiety in Preoperative Waiting using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety	preoperative period- 1 day	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Waltham, Massachusetts, United States