Back to resultsPIRA vs Standard Preoperative Education
Primary Purpose
Anesthesia, Anesthesia Emergence Delirium, Procedural Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pediatric Interactive Relational Agent (PIRA)
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia focused on measuring education
Eligibility Criteria
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
Sites / Locations
- Boston Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Education
Pediatric Interactive Relational Agent (PIRA)
Arm Description
This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.
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.
Outcomes
Primary Outcome Measures
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.
Parental Perceived Impact and Impressions assessed through the Parental PIRA Survey
This survey assesses parental opinions about the PIRA.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04586569
First Posted
September 15, 2020
Last Updated
November 16, 2022
Sponsor
Boston Children's Hospital
Collaborators
Northeastern University
1. Study Identification
Unique Protocol Identification Number
NCT04586569
Brief Title
PIRA vs Standard Preoperative Education
Official Title
A Pilot Randomized Control Trial Testing the Acceptability and Feasibility of a Pediatric Interactive Relational Agent (PIRA) vs. Standard Preoperative Education
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
November 13, 2023 (Anticipated)
Study Completion Date
November 13, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Northeastern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Anesthesia Emergence Delirium, Procedural Anxiety
Keywords
education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Masking Description
The research team member handing out surveys and observing children for anxiety are masked. The PACU nurse observing for emergence agitation post-op is also masked.
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Education
Arm Type
No Intervention
Arm Description
This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.
Arm Title
Pediatric Interactive Relational Agent (PIRA)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pediatric Interactive Relational Agent (PIRA)
Intervention Description
The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience.
Primary Outcome Measure Information:
Title
Parental Utilization
Description
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.
Time Frame
2-10 days
Title
Parental Perceived Impact and Impressions assessed through the Parental PIRA Survey
Description
This survey assesses parental opinions about the PIRA.
Time Frame
preoperative period - 1 day
Secondary Outcome Measure Information:
Title
Child Anxiety in Preoperative Waiting using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety
Description
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.
Time Frame
preoperative period - 1 day
Title
Parental Anxiety in Preoperative Waiting using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety
Description
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.
Time Frame
preoperative period- 1 day
Title
Emergence from Anesthesia: Presence or absence of emergence agitation/delirium (ED) using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia scale
Description
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.
Time Frame
immediately postop - 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Bulich, MD
Phone
617-355-7737
Email
linda.bulich@childrens.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Booth, BSN
Phone
857-218-4585
Email
jocelyn.booth@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Bulich
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Bulich, MD
Phone
617-355-7737
Email
linda.bulich@childrens.harvard.edu
12. IPD Sharing Statement
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PIRA vs Standard Preoperative Education
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