PIRA vs Standard Preoperative Education

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia, Anesthesia Emergence Delirium, Procedural Anxiety

Intervention / Treatment
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* Other: Pediatric Interactive Relational Agent (PIRA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Education<br>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)<br>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)<br>* The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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education