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NCT04586569 · ClinicalTrials.gov registry record · NA
A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 76
- Enrollment target
NCT04586569: Completed NA study, sponsored by Boston Children's Hospital.
NCT04586569 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 76 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04586569, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Pediatric Interactive Relational Agent (PIRA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-07-06 |
| Est. Completion | 2023-10-19 |
| Phase | NA |
What the finished NCT04586569 record still lists
NCT04586569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Pediatric Interactive Relational Agent (PIRA) is the first listed.
NCT04586569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04586569 about?
NCT04586569 is a clinical study titled "A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education". 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 stu...
What is the current status of trial NCT04586569?
This trial is currently completed. It is a NA study. The enrollment target is 76 participants. The study started on 2021-07-06. Estimated completion is 2023-10-19.
What interventions are being tested in trial NCT04586569?
The interventions under investigation include: Pediatric Interactive Relational Agent (PIRA) (OTHER).
Who is sponsoring clinical trial NCT04586569?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04586569's enrollment target sits among peer trials
76 1062nd of 2000 higher than 932 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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