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PIRA vs Standard Preoperative Education

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586569
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : November 17, 2022
Sponsor:
Collaborator:
Northeastern University
Information provided by (Responsible Party):
Linda Bulich, Boston Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anesthesia Anesthesia Emergence Delirium Procedural Anxiety Other: Pediatric Interactive Relational Agent (PIRA) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes 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.
Primary Purpose: Prevention
Official Title: A Pilot Randomized Control Trial Testing the Acceptability and Feasibility of a Pediatric Interactive Relational Agent (PIRA) vs. Standard Preoperative Education
Actual Study Start Date : July 6, 2021
Estimated Primary Completion Date : November 13, 2023
Estimated Study Completion Date : November 13, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Standard Education
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)
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)
The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience.


Outcome Measures
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Primary Outcome Measures :
  1. Parental Utilization [ Time Frame: 2-10 days ]
    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. Parental Perceived Impact and Impressions assessed through the Parental PIRA Survey [ Time Frame: preoperative period - 1 day ]
    This survey assesses parental opinions about the PIRA.


Secondary Outcome Measures :
  1. Child Anxiety in Preoperative Waiting using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety [ Time Frame: preoperative period - 1 day ]
    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.

  2. Parental Anxiety in Preoperative Waiting using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety [ Time Frame: preoperative period- 1 day ]
    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.

  3. Emergence from Anesthesia: Presence or absence of emergence agitation/delirium (ED) using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia scale [ Time Frame: immediately postop - 1 day ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586569


Contacts
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Contact: Linda Bulich, MD 617-355-7737 linda.bulich@childrens.harvard.edu
Contact: Jocelyn Booth, BSN 857-218-4585 jocelyn.booth@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Waltham, Massachusetts, United States, 02453
Contact: Linda Bulich, MD    617-355-7737    linda.bulich@childrens.harvard.edu   
Sponsors and Collaborators
Boston Children's Hospital
Northeastern University
Investigators
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Principal Investigator: Linda Bulich Boston Children's Hospital
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Linda Bulich, Attending Anesthesiologist, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04586569    
Other Study ID Numbers: P00035987
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Linda Bulich, Boston Children's Hospital:
education
Additional relevant MeSH terms:
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Emergence Delirium
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes