A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Rela… (NCT04586569) | Clinical Trial Compass
CompletedNot Applicable
A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education
United States76 participantsStarted 2021-07-06
Plain-language 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.
Who can participate
Age range
4 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Child Anxiety in Preoperative Waiting Room Using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety
Timeframe: Preoperative Period - 1 day
2
Parental Anxiety in Preoperative Waiting Room Using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety
Timeframe: Preoperative period- 1 day
3
Emergence From Anesthesia: Presence or Absence of Emergence Agitation/Delirium (ED) Using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia Scale