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

Boston Children's Hospital

Status: Completed

Conditions: Procedural Anxiety; Anesthesia Emergence Delirium; Anesthesia

Treatments: Other: Pediatric Interactive Relational Agent (PIRA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04586569

P00035987

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 76 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Standard Education

No Intervention group

Description:

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

Pediatric Interactive Relational Agent (PIRA)

Experimental group

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.

Treatment:

Other: Pediatric Interactive Relational Agent (PIRA)