At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
In Brief
A clinical study evaluating Buzzy® and Music for Syncope, Vasovagal. Completed, enrolled 30 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.
Music will be selected and listened to as a distraction before and during vaccination.