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 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: Completed
• Conditions: Syncope, Vasovagal
• Intervention / Treatment: Device: Buzzy®; Behavioral: Music

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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	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	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	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	Subjects will be asked to complete an anxiety assessment prior to vaccination	Day1
Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment	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.	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	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	Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s	Day1
Number of Subjects Who Complete the Post Vaccination Anxiety Assessment	Subjects will complete a post vaccination anxiety assessment	Day1
Number of Subjects Who Complete the Acceptability Assessment	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations	Day1

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: 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

Study Major Dates

• Study Start (Actual): June 4, 2018
• Primary Completion (Actual): July 19, 2018
• Study Completion (Actual): July 19, 2018

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: May 11, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: vaccination; pre-syncope; syncope prevention
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID 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