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NCT03690531 · ClinicalTrials.gov registry record
Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department
A clinical trial, sponsored by Antonios Likourezos.
- Completed
- Registry status
- 110
- Enrollment target
NCT03690531: Completed study, sponsored by Antonios Likourezos.
NCT03690531 is a clinical trial that has completed, run by Antonios Likourezos. The registered enrollment target is 110 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03690531 has completed, sponsored by Antonios Likourezos.
- COMPLETED
- Registry status
- 110 participants
- Enrollment target
Study Summary
Non-pharmacological interventions including distraction techniques (ie., games, ipads, bubbles, stickers) are standard of care in reducing situation anxiety for children in the pediatric emergency department. The goal of the study is to evaluate the efficacy of a mindfulness based virtual reality (mbVR) tool (Take-Pause) for pediatric patients age \> 12 years. The study team will be providing children with a virtual reality experience upon arrival to the emergency department and measuring the effectiveness of the intervention versus standard of care (Ipads, games). Subjective measurements will include questionnaires and objective measurements will include vital signs.
Primary Outcome
The primary outcome is to decrease situational anxiety level by at least 5 points on a State Trait Anxiety Inventory scale when comparing mbVR to passive distraction technique. The scores range from 20 to 80 with high score indicating higher levels of anxiety.
Interventions
- DEVICE Take-Pause virtual reality
- DEVICE Passive Distraction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2018-11-28 |
| Est. Completion | 2019-08-31 |
What the finished NCT03690531 record still lists
NCT03690531 is an observational study that tracks outcomes without assigning an intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Take-Pause virtual reality is the first listed.
NCT03690531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03690531 about?
NCT03690531 is a clinical study titled "Efficacy of Mindfulness as an Intervention in the Pediatric Emergency Department". Non-pharmacological interventions including distraction techniques (ie., games, ipads, bubbles, stickers) are standard of care in reducing situation anxiety for children in the pediatric emergency department. The goal of the study is to evaluate the efficacy of a mindfulness based virtual reality (m...
What is the current status of trial NCT03690531?
This trial is currently completed. The enrollment target is 110 participants. The study started on 2018-11-28. Estimated completion is 2019-08-31.
What interventions are being tested in trial NCT03690531?
The interventions under investigation include: Take-Pause virtual reality (DEVICE), Passive Distraction (DEVICE).
Who is sponsoring clinical trial NCT03690531?
This trial is sponsored by Antonios Likourezos, which has 33 total clinical trials registered on ClinicalTrials.gov.
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