A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-06

Study Completion Date

2023-10-19

Brief Summary

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The purpose of this study is to determine the efficacy of enhanced preoperative education using a Pediatric Interactive Relational Agent (PIRA), designed for children aged 4 through 10 years and their families, compared to the standard preoperative education currently provided. Specifically, the study aimed to evaluate differences in parent/child preoperative anxiety, and child experience with emergence from anesthesia. A secondary aim was to evaluate the child's and the parent's access and utilization the Pediatric Interactive Relational Agent as well as parental satisfaction and difficulties with the tool.

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Detailed Description

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This summary is a change from the original study/title where the secondary aim (from the original submission) is now the primary aim of the study and the primary aim (from the original submission) is now the secondary aim. This change was made following the first revision of the manuscript by the Editor in Chief and two separate reviewers. The manuscript was then rejected after a second review despite agreeing to reverse the primary and secondary outcomes as suggested by the reviewers. The Editor in Chief rejected this second submission stating that the newest revision (second revision) was not consistent with my original submission to ClinicalTrials.org. I am interested in submitting this manuscript to another journal yet wanted the changes to be updated in ClinicalTrials.org before resubmission.

Conditions

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Anesthesia Anesthesia Emergence Delirium Procedural Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

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.

Study Groups

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Standard Education

This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Pediatric Interactive Relational Agent (PIRA)

Intervention Type OTHER

The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience.

Interventions

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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.

Intervention Type OTHER

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

Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No