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NCT04772755 · ClinicalTrials.gov registry record · NA
Presyncope (Syncope) Prevention Study
A NA study of Syncope, Vasovagal, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 338
- Enrollment target
- 2
- Study locations
NCT04772755 is a NA study of Syncope, Vasovagal that has completed, run by Duke University. The registered enrollment target is 338 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT04772755, a NA study of Syncope, Vasovagal, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 338 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study was a prospective, randomized clinical trial that was conducted in adolescents (10 through 14 years of age) receiving at least one recommended intramuscularly administered vaccine to evaluate the efficacy and acceptability of using two different, simultaneously administered interventions that might prevent post-vaccination presyncope, and by extension syncope. The two interventions evaluated together were Buzzy®, which is a medical device designed to reduce vaccination pain, and an electronic game. The investigators evaluated both interventions when administered simultaneously (Buzzy® and electronic game). The investigators enrolled approximately 340 subjects into this study. Eligible adolescents were randomized (1:1) to either the intervention or control group: 1) intervention (Buzzy® and electronic game); or 2) control (usual care) to assess for acceptability and efficacy. Detailed data were collected and described from study participants including demographics, medical history, baseline generalized and state anxiety, and needle phobia. Participants were observed for 20 minutes following receipt of vaccines and reassessed for post-vaccination state anxiety, immediate and subsequent post-vaccination pain (within 1 minute and at 10 minutes), and the occurrence of witnessed syncope or presyncope, and presyncopal symptoms as rated by the modified Blood Donation Reactions Inventory (BDRI). Participants were asked to assess their acceptability of the intervention.
Conditions Studied
Interventions
- DEVICE Buzzy® and Electronic Game
Study Locations (2)
Georgia
- Centers for Disease Control and Prevention - Atlanta
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 338 participants |
| Start Date | 2021-03-10 |
| Est. Completion | 2022-06-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04772755
The ClinicalTrials.gov registry entry for NCT04772755 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 338 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Syncope, Vasovagal appearing as the primary indexed condition, and to 1 intervention - of which Buzzy® and Electronic Game is the first listed.
NCT04772755 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Georgia, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04772755 about?
NCT04772755 is a clinical study titled "Presyncope (Syncope) Prevention Study". This study was a prospective, randomized clinical trial that was conducted in adolescents (10 through 14 years of age) receiving at least one recommended intramuscularly administered vaccine to evaluate the efficacy and acceptability of using two different, simultaneously administered interventions ...
What is the current status of trial NCT04772755?
This trial is currently completed. It is a NA study. The enrollment target is 338 participants. The study started on 2021-03-10. Estimated completion is 2022-06-15.
What conditions does trial NCT04772755 study?
This clinical trial studies the following conditions: Syncope, Vasovagal.
What interventions are being tested in trial NCT04772755?
The interventions under investigation include: Buzzy® and Electronic Game (DEVICE).
Who is sponsoring clinical trial NCT04772755?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04772755 being conducted?
This trial has 2 study locations across Georgia, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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