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Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study

NCT03533829 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-08-16

Study results available
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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

  • Syncope, Vasovagal

Interventions

DEVICE

Buzzy®

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.

BEHAVIORAL

Music

Music will be selected and listened to as a distraction before and during vaccination.

Sponsors & Collaborators

Principal Investigators

  • Emmanuel "Chip" B Walter, MD, MPH · Duke Univeristy

  • Theresa Harrington, MD, MPH&TM · Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2018-07-19
Completion
2018-07-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533829 on ClinicalTrials.gov