PIRA vs Standard Preoperative Education
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|ClinicalTrials.gov Identifier: NCT04586569|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : November 17, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Anesthesia Emergence Delirium Procedural Anxiety||Other: Pediatric Interactive Relational Agent (PIRA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||4 Years to 10 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|Contact: Linda Bulich, MDfirstname.lastname@example.org|
|Contact: Jocelyn Booth, BSNemail@example.com|
|United States, Massachusetts|
|Boston Children's Hospital||Recruiting|
|Waltham, Massachusetts, United States, 02453|
|Contact: Linda Bulich, MD 617-355-7737 firstname.lastname@example.org|
|Principal Investigator:||Linda Bulich||Boston Children's Hospital|
|Responsible Party:||Linda Bulich, Attending Anesthesiologist, Boston Children's Hospital|
|Other Study ID Numbers:||
|First Posted:||October 14, 2020 Key Record Dates|
|Last Update Posted:||November 17, 2022|
|Last Verified:||November 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Nervous System Diseases