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

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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

Tracking Information
First Submitted Date  ICMJE May 11, 2018
First Posted Date  ICMJE May 23, 2018
Results First Submitted Date  ICMJE July 9, 2019
Results First Posted Date  ICMJE August 16, 2019
Last Update Posted Date August 16, 2019
Actual Study Start Date  ICMJE June 4, 2018
Actual Primary Completion Date July 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Number of Subjects Who Complete the Post Vaccination Anxiety Assessment [ Time Frame: Day1 ]
    Subjects will complete a post vaccination anxiety assessment
  • Number of Subjects Who Complete the Acceptability Assessment [ Time Frame: Day1 ]
    Subjects will be given a questionnaire about the acceptability of their intervention.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
  • Feasibility Benchmark: Proportion 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.
  • Feasibility Benchmark: Proportion 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.
  • Feasibility Benchmark: Proportion 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
  • Feasibility Benchmark: Proportion 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
  • Feasibility Benchmark: Proportion of subjects who complete the pre-vaccination anxiety assessment [ Time Frame: Day1 ]
    Subjects will be asked to complete an anxiety assessment prior to vaccination
  • Feasibility Benchmark: Proportion 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
  • Feasibility Benchmark: Proportion 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
  • Feasibility Benchmark: Proportion 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
  • Feasibility Benchmark: Proportion 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
  • Feasibility Benchmark: Proportion of subjects who complete the post vaccination anxiety assessment [ Time Frame: Day1 ]
    Subjects will complete a post vaccination anxiety assessment
  • Feasibility Benchmark: Proportion of subjects who complete the acceptability assessment [ Time Frame: Day1 ]
    Subjects will be given a questionnaire about the acceptability of their intervention.
  • Coordinator Feasibility Survey: Proportion 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
  • Coordinator Feasibility Survey: Proportion 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
  • Coordinator Feasibility Survey: Proportion 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
  • Coordinator Feasibility Survey: Proportion 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
  • Provider Feasibility Survey: Proportion 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
  • Provider Feasibility Survey: Proportion 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
  • Provider Feasibility Survey: Proportion 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
  • Provider Feasibility Survey: Proportion 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
  • Music Acceptability Survey: Proportion 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
  • Music Acceptability Survey: Proportion 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
  • Music Acceptability Survey: Proportion 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
  • Music Acceptability Survey: Proportion 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
  • Music Acceptability Survey: Proportion 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
  • Music Acceptability Survey: Proportion 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
  • Buzzy® Acceptability Survey: Proportion 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
  • Buzzy® Acceptability Survey: Proportion 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
  • Buzzy® Acceptability Survey: Proportion 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
  • Buzzy® Acceptability Survey: Proportion 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
  • Buzzy® Acceptability Survey: Proportion 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
  • Buzzy® Acceptability Survey: Proportion 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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
Official Title  ICMJE Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Syncope, Vasovagal
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Buzzy®
  • Active Comparator: Music
    Music will be selected and listened to as a distraction before and during vaccination.
    Intervention: Behavioral: Music
  • 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.
    Interventions:
    • Device: Buzzy®
    • Behavioral: Music
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 19, 2018
Actual Primary Completion Date July 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03533829
Other Study ID Numbers  ICMJE PRO00094074
200 2012 53663 0013 ( Other Grant/Funding Number: CDC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Emmanuel "Chip" B Walter, MD, MPH Duke Univeristy
Principal Investigator: Theresa Harrington, MD, MPH&TM Centers for Disease Control and Prevention
PRS Account Duke University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP