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NCT06111742 · ClinicalTrials.gov registry record · NA
Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety
A NA study of Anxiety, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 178
- Enrollment target
- 1
- Study location
NCT06111742: Completed NA study of Anxiety, sponsored by Yale University.
NCT06111742 is a NA study of Anxiety that has completed, run by Yale University. The registered enrollment target is 178 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06111742, a NA study of Anxiety, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 178 participants
- Enrollment target
- 1
- Study location
Study Summary
Pediatric anxiety upon induction of anesthesia is widely prevalent and can lead to negative patient psychological impact and hindrance to induction of anesthesia. Historically, premedication has been used as one means to improve pediatric preoperative anxiety and cooperation with induction. However, giving medication to children prior to surgery has drawbacks. Thus, other means have been proposed that may have similar benefits but fewer or different drawbacks. Recently, audiovisual distraction in the form of interactive games has been proposed. Such games have been in use at children's hospitals around the United States for more than five years. This study is a randomized trial that will explore using interactive games to improve pediatric perioperative anxiety in elective surgery compared with standard-of-care not including games. Perioperative anxiety with be evaluated using an observational scale.
Primary Outcome
The mYPAS is the gold standard for measuring pediatric perioperative anxiety. It is an observational-based 22-item instrument divided into five categories: activity, emotional expressivity, state of arousal, vocalization, and use of parents. The score ranges from 23 to 100, higher scores suggest higher levels of anxiety. It was developed at Yale University. This will be used for child participants only. Results presented here are mean change from baseline in anxiety during induction and upon Ope
Conditions Studied
Interventions
- DEVICE Bedside Entertainment and Relaxation Theater (BERT)
Study Locations (1)
Connecticut
- Yale New Haven Children's Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 178 participants |
| Start Date | 2023-11-14 |
| Est. Completion | 2024-02-12 |
| Phase | NA |
What the finished NCT06111742 record still lists
NCT06111742 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Anxiety appearing as the primary indexed condition, and to 1 intervention - of which Bedside Entertainment and Relaxation Theater (BERT) is the first listed.
NCT06111742 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06111742 about?
NCT06111742 is a clinical study titled "Audiovisual Interactive Games to Alleviate Pediatric Perioperative Anxiety". Pediatric anxiety upon induction of anesthesia is widely prevalent and can lead to negative patient psychological impact and hindrance to induction of anesthesia. Historically, premedication has been used as one means to improve pediatric preoperative anxiety and cooperation with induction. However,...
What is the current status of trial NCT06111742?
This trial is currently completed. It is a NA study. The enrollment target is 178 participants. The study started on 2023-11-14. Estimated completion is 2024-02-12.
What conditions does trial NCT06111742 study?
This clinical trial studies the following conditions: Anxiety.
What interventions are being tested in trial NCT06111742?
The interventions under investigation include: Bedside Entertainment and Relaxation Theater (BERT) (DEVICE).
Who is sponsoring clinical trial NCT06111742?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06111742 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06111742's enrollment target sits among peer trials
178 97th of 364 higher than 268 of 364 other Anxiety trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anxiety 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.
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