Back to resultsPreventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
Primary Purpose
Syncope, Vasovagal
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Buzzy®
Music
Sponsored by
About this trial
This is an interventional device feasibility trial for Syncope, Vasovagal focused on measuring vaccination, pre-syncope, syncope prevention
Eligibility Criteria
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
Sites / Locations
- Centers for Disease Control and Prevention
- Duke University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Buzzy®
Music
Buzzy® and Music
Arm Description
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 will be selected and listened to as a distraction before and during vaccination.
Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.
Outcomes
Primary Outcome Measures
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.
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.
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
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
Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
Subjects will be asked to complete an anxiety assessment prior to vaccination
Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
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.
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
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
Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s
Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
Subjects will complete a post vaccination anxiety assessment
Number of Subjects Who Complete the Acceptability Assessment
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Secondary Outcome Measures
Full Information
NCT ID
NCT03533829
First Posted
May 11, 2018
Last Updated
July 9, 2019
Sponsor
Duke University
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT03533829
Brief Title
Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
Official Title
Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
July 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Centers for Disease Control and Prevention
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal
Keywords
vaccination, pre-syncope, syncope prevention
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buzzy®
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Music
Arm Type
Active Comparator
Arm Description
Music will be selected and listened to as a distraction before and during vaccination.
Arm Title
Buzzy® and Music
Arm Type
Active Comparator
Arm Description
Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.
Intervention Type
Device
Intervention Name(s)
Buzzy®
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Music
Intervention Description
Music will be selected and listened to as a distraction before and during vaccination.
Primary Outcome Measure Information:
Title
Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
Description
Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Time Frame
Day1
Title
Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure
Description
Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.
Time Frame
Day1
Title
Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination
Description
Music will be played over speakers for a minimum of 3 minutes prior to vaccination
Time Frame
Day1
Title
Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination
Description
Music will be played over speakers through the 10 minute post vaccination pain assessment
Time Frame
Day1
Title
Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
Description
Subjects will be asked to complete an anxiety assessment prior to vaccination
Time Frame
Day1
Title
Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
Description
Subjects will be asked to complete a needle phobia assessment pre-vaccination
Time Frame
Day1
Title
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.
Description
Subjects will complete a post vaccination pain assessment within one minute of their final vaccination
Time Frame
Day1
Title
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes
Description
Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination
Time Frame
Day1
Title
Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment
Description
Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s
Time Frame
Day1
Title
Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
Description
Subjects will complete a post vaccination anxiety assessment
Time Frame
Day1
Title
Number of Subjects Who Complete the Acceptability Assessment
Description
Subjects will be given a questionnaire about the acceptability of their intervention.
Time Frame
Day1
Title
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Description
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time Frame
Day1
Title
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Description
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time Frame
Day1
Title
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Description
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time Frame
Day1
Title
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Description
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time Frame
Day1
Title
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Description
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time Frame
Day1
Title
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Description
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time Frame
Day1
Title
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Description
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time Frame
Day1
Title
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Description
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time Frame
Day1
Title
Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much
Description
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy
Description
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable
Description
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right
Description
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s
Description
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like
Description
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s
Description
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy
Description
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable
Description
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s
Description
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s
Description
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame
Day1
Title
Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again
Description
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame
Day1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel "Chip" B Walter, MD, MPH
Organizational Affiliation
Duke Univeristy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Theresa Harrington, MD, MPH&TM
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centers for Disease Control and Prevention
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30333
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
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