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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03533829
Recruitment Status : Completed
First Posted : May 23, 2018
Results First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Syncope, Vasovagal Device: Buzzy® Behavioral: Music Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : July 19, 2018
Actual Study Completion Date : July 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

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.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533829


Locations
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United States, Georgia
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Emmanuel "Chip" B Walter, MD, MPH Duke Univeristy
Principal Investigator: Theresa Harrington, MD, MPH&TM Centers for Disease Control and Prevention
  Study Documents (Full-Text)

Documents provided by Duke University:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03533829     History of Changes
Other Study ID Numbers: PRO00094074
200 2012 53663 0013 ( Other Grant/Funding Number: CDC )
First Posted: May 23, 2018    Key Record Dates
Results First Posted: August 16, 2019
Last Update Posted: August 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
vaccination
pre-syncope
syncope prevention
Additional relevant MeSH terms:
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Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs