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OpenTrials
Completed

NCT Number: NCT03533829

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.

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Key information

Conditions

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

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centers for Disease Control and Prevention, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 10 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Music

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Number of Subjects Who Complete the Post Vaccination Anxiety Assessment

    Time frame: Day1

    Subjects will complete a post vaccination anxiety assessment

  11. Number of Subjects Who Complete the Acceptability Assessment

    Time frame: Day1

    Subjects will be given a questionnaire about the acceptability of their intervention.

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 23, 2018
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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