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NCT03533829 · ClinicalTrials.gov registry record · NA
Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
A NA study of Syncope, Vasovagal, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT03533829: Completed NA study of Syncope, Vasovagal, sponsored by Duke University.
NCT03533829 is a NA study of Syncope, Vasovagal that has completed, run by Duke University. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03533829, a NA study of Syncope, Vasovagal, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to being used in a larger study to assess the effectiveness of the interventions in preventing post-vaccination presyncope and syncope. Feasibility will be assessed according to study staff ability to successfully administer the protocol specified clinic-based interventions and per both study staff and healthcare provider responses to written feasibility assessments. Acceptability will be assessed according to the participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed per participant written self-report to standardized survey questions.
Primary Outcome
Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Conditions Studied
Interventions
- BEHAVIORAL Music
- DEVICE Buzzy®
Study Locations (2)
Georgia
- Centers for Disease Control and Prevention - Atlanta
North Carolina
- Duke University - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-06-04 |
| Est. Completion | 2018-07-19 |
| Phase | NA |
What the finished NCT03533829 record still lists
NCT03533829 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Syncope, Vasovagal appearing as the primary indexed condition, and to 2 interventions - of which Music is the first listed.
NCT03533829 reports a single indexed study location in Georgia, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03533829 about?
NCT03533829 is a clinical study titled "Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study". This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these inte...
What is the current status of trial NCT03533829?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2018-06-04. Estimated completion is 2018-07-19.
What conditions does trial NCT03533829 study?
This clinical trial studies the following conditions: Syncope, Vasovagal.
What interventions are being tested in trial NCT03533829?
The interventions under investigation include: Music (BEHAVIORAL), Buzzy® (DEVICE).
Who is sponsoring clinical trial NCT03533829?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03533829 being conducted?
This trial has 2 study locations across Georgia, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03533829's enrollment target sits among peer trials
30 1593rd of 2000 higher than 299 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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