Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study of Syncope, Vasovagal that has completed, run by Duke University. The registered enrollment target is 30 participants. The trial reports 2 study locations across 2 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03533829
The ClinicalTrials.gov registry entry for NCT03533829 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 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 2 interventions - of which Music is the first listed.
NCT03533829 reports 2 study locations spanning 2 distinct geographic areas - top geographies include 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
Similar trials for Syncope, Vasovagal
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.