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

NCT04586569 | Completed Results

• 1 other identifier: P00035987
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Anesthesia Emergence Delirium; Procedural Anxiety

Keywords

education

Outcome Measures

Primary Outcomes (3)

• Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety

  The observational tool will be used to determine if there is a difference in anxiety between children who reviewed the PIRA and those who did not (control group). It will look at the incidence and severity of anxiety in children who received the PIRA vs. those who received standard preoperative education. This scale produces a score ranging from 22.92 to 100, with higher values indicating greater anxiety.

  Preoperative Period - 1 day

• Parental Anxiety in Preoperative Waiting Room 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. Parental anxiety was assessed using the State-Trait Anxiety Inventory. The self-report anxiety instrument includes two separate 20-item subscales that measure trait (baseline) and state (situational) anxiety. The State-Trait Anxiety Inventory is scored from 20-80, with higher scores indicating more anxiety

  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 emergence delirium for children who have more interactive preoperative education, such as PIRA, compared to standard information. The Post Anesthesia Emergence Delirium scale measures five behaviors, each rated on a five-point scale of 0 to 4. The scores are summed for a total score, with a maximum value of 20. An assessment of the internal consistency and reliability of the Post Anesthesia Emergence Delirium scale validated it for assessing emergence delirium in children recovering from general anesthesia.20 A score of \>12 yields 100 percent sensitivity and 94.5 percent specificity for the diagnosis of emergence delirium. For this study, emergence delirium was considered present with a score of \>12.

  immediately postop in the PACU - 1 day

Secondary Outcomes (2)

• Parental Perceived Impact and Impressions Assessed Through the Parental PIRA Survey

  Preoperative period - 1 day

• Parental Utilization

  2-10 days before the day of surgery

Study Arms (2)

Standard Education

NO INTERVENTION

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

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)

Interventions

Pediatric Interactive Relational Agent (PIRA) OTHER

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

Pediatric Interactive Relational Agent (PIRA)

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Northeastern University: collaborator

Study Sites (1)

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Linda Bulich
• Organization: Boston Children's Hospital

linda.bulich@childrens.harvard.edu

617-355-7737

Study Officials

• Linda Bulich

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 14, 2020
• Study Start: July 6, 2021
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: November 4, 2025
• Results First Posted: November 4, 2025

Record last verified: 2025-10

Locations

US (1)