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

NCT03533829 | Completed Results FDA Device

• 2 other identifiers: PRO00094074200 2012 53663 0013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

vaccination; pre-syncope; syncope prevention

Outcome Measures

Primary Outcomes (31)

• 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

Study Arms (3)

Buzzy®

ACTIVE COMPARATOR

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®

Music

ACTIVE COMPARATOR

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

Behavioral: Music

Buzzy® and Music

ACTIVE COMPARATOR

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®; Behavioral: Music

Interventions

Buzzy® DEVICE

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.

Buzzy®; Buzzy® and Music

Music BEHAVIORAL

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

Buzzy® and Music; Music

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years through 17 years of age
• If 10 through 13 years of age, the subject must be receiving at least one vaccine delivered intramuscularly
• If 14 through 17 years of age, the subject must be receiving at least two injectable vaccines one of which must be delivered intramuscularly
• 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.
• The subject must be willing to stay for the completion of all study-related activities.
• Parent/guardian and adolescent must speak and read English by self-report

You may not qualify if:

• Receipt of investigational or experimental vaccine or medication within the previous two weeks
• Receipt of routine injectable medication
• Permanent indwelling venous catheter
• Blood drawn within the past hour or scheduled for a blood draw during the post-vaccination observation period
• Injection of medication during the past hour or scheduled for injection of medication during the observation period.
• Cold intolerance or cold urticaria
• Raynaud's phenomenon
• Sickle cell disease
• Inability to hear
• Significant visual impairment or blindness
• Febrile or acutely ill individuals
• Upper arm or shoulder pain or injury
• Adolescent or parent/Guardian is an immediate relative of study staff or an employee who is supervised by study staff.
• 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

Sponsors & Collaborators

• Duke University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Syncope, Vasovagal; Syncope

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Kristen Gunnell
• Organization: Duke Vaccine and Trials Unit

kristen.gunnell@duke.edu

9196848891

Study Officials

• Emmanuel "Chip" B Walter, MD, MPH

  Duke Univeristy

  PRINCIPAL INVESTIGATOR

• Theresa Harrington, MD, MPH&TM

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 23, 2018
• Study Start: June 4, 2018
• Primary Completion: July 19, 2018
• Study Completion: July 19, 2018
• Last Updated: August 16, 2019
• Results First Posted: August 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)