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

July 9, 2019 updated by: Duke University
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30333
        • Centers for Disease Control and Prevention
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 10 years through 17 years of age
  2. If 10 through 13 years of age, the subject must be receiving at least one vaccine delivered intramuscularly
  3. If 14 through 17 years of age, the subject must be receiving at least two injectable vaccines one of which must be delivered intramuscularly
  4. The parent/guardian must be willing and capable of providing written informed consent for the adolescent and the adolescent must be willing and capable of providing assent.
  5. The subject must be willing to stay for the completion of all study-related activities.
  6. Parent/guardian and adolescent must speak and read English by self-report

Exclusion Criteria:

  1. Receipt of investigational or experimental vaccine or medication within the previous two weeks
  2. Receipt of routine injectable medication
  3. Permanent indwelling venous catheter
  4. Blood drawn within the past hour or scheduled for a blood draw during the post-vaccination observation period
  5. Injection of medication during the past hour or scheduled for injection of medication during the observation period.
  6. Cold intolerance or cold urticaria
  7. Raynaud's phenomenon
  8. Sickle cell disease
  9. Inability to hear
  10. Significant visual impairment or blindness
  11. Febrile or acutely ill individuals
  12. Upper arm or shoulder pain or injury
  13. Adolescent or parent/Guardian is an immediate relative of study staff or an employee who is supervised by study staff.
  14. Any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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.
Active Comparator: Music
Music will be selected and listened to as a distraction before and during vaccination.
Behavioral: Music
Music will be selected and listened to as a distraction before and during vaccination.
Active Comparator: Buzzy® and Music
Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
Time Frame: Day1
Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Day1
Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure
Time Frame: Day1
Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.
Day1
Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination
Time Frame: Day1
Music will be played over speakers for a minimum of 3 minutes prior to vaccination
Day1
Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination
Time Frame: Day1
Music will be played over speakers through the 10 minute post vaccination pain assessment
Day1
Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
Time Frame: Day1
Subjects will be asked to complete an anxiety assessment prior to vaccination
Day1
Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
Time Frame: Day1
Subjects will be asked to complete a needle phobia assessment pre-vaccination
Day1
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.
Time Frame: Day1
Subjects will complete a post vaccination pain assessment within one minute of their final vaccination
Day1
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes
Time Frame: Day1
Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination
Day1
Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment
Time Frame: Day1
Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s
Day1
Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
Time Frame: Day1
Subjects will complete a post vaccination anxiety assessment
Day1
Number of Subjects Who Complete the Acceptability Assessment
Time Frame: Day1
Subjects will be given a questionnaire about the acceptability of their intervention.
Day1
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Time Frame: Day1
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Day1
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Time Frame: Day1
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Day1
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Time Frame: Day1
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Day1
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Time Frame: Day1
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Day1
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Time Frame: Day1
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Day1
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Time Frame: Day1
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Day1
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Time Frame: Day1
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Day1
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Time Frame: Day1
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Day1
Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much
Time Frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Day1
Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy
Time Frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Day1
Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable
Time Frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Day1
Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right
Time Frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Day1
Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s
Time Frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Day1
Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like
Time Frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Day1
Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s
Time Frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Day1
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy
Time Frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Day1
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable
Time Frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Day1
Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s
Time Frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Day1
Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s
Time Frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Day1
Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again
Time Frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Day1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emmanuel "Chip" B Walter, MD, MPH, Duke Univeristy
  • Principal Investigator: Theresa Harrington, MD, MPH&TM, Centers for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO00094074
  • 200 2012 53663 0013 (Other Grant/Funding Number: CDC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings