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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03533829
• Collaborator: Centers for Disease Control and Prevention (U.S. Fed)
• Enrollment: 30
• Locations: 2
• Arms: 3
• Actual Duration (Months): 1.5
• Patients Per Site: 15
• Patients Per Site Per Month: 10.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Syncope, Vasovagal	Device: Buzzy®; Behavioral: Music	N/A

Study Design

• Study Type: Interventional
• 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: Jun 4, 2018
• Actual Primary Completion Date: Jul 19, 2018
• Actual Study Completion Date: Jul 19, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination [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 [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 [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 [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 [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 [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. [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 [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 [Day1]

   Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s

10. Number of Subjects Who Complete the Post Vaccination Anxiety Assessment [Day1]

    Subjects will complete a post vaccination anxiety assessment

11. Number of Subjects Who Complete the Acceptability Assessment [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Day1]

    Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centers for Disease Control and Prevention	Atlanta	Georgia	United States	30333
2	Duke University	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University
• Centers for Disease Control and Prevention

Investigators

• 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)

• Study Protocol and Statistical Analysis Plan - Apr 17, 2018

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03533829
• Other Study ID Numbers: PRO00094074; 200 2012 53663 0013
• First Posted: May 23, 2018
• Last Update Posted: Aug 16, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Duke University: vaccination; pre-syncope; syncope prevention
• Additional relevant MeSH terms: Syncope; Syncope, Vasovagal

Study Results

Participant Flow

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Period Title: Overall Study
STARTED	10	10	10
COMPLETED	10	10	10
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Buzzy®	Music	Buzzy® and Music	Total
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.	Total of all reporting groups
Overall Participants	10	10	10	30
Age, Customized (Count of Participants)
10-13 years	8 80%	6 60%	10 100%	24 80%
14-17 years	2 20%	4 40%	0 0%	6 20%
Sex: Female, Male (Count of Participants)
Female	3 30%	3 30%	4 40%	10 33.3%
Male	7 70%	7 70%	6 60%	20 66.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 10%	0 0%	0 0%	1 3.3%
Not Hispanic or Latino	9 90%	10 100%	10 100%	29 96.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	2 20%	2 20%	2 20%	6 20%
White	7 70%	8 80%	7 70%	22 73.3%
More than one race	0 0%	0 0%	1 10%	1 3.3%
Other race	1 10%	0 0%	0 0%	1 3.3%
Region of Enrollment (Count of Participants)
United States	10 100%	10 100%	10 100%	30 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	10 100%	0 0%	10 100%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	9 90%	0 0%	10 100%

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	10
Count of Participants [Participants]	0 0%	10 100%	10 100%

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	10
Count of Participants [Participants]	0 0%	8 80%	7 70%

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	10	10
Count of Participants [Participants]	10 100%	10 100%	10 100%

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	10	10
Count of Participants [Participants]	10 100%	10 100%	10 100%

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated.

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	10	10
Count of Participants [Participants]	4 40%	7 70%	3 30%

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated.

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	10	10
Count of Participants [Participants]	8 80%	10 100%	9 90%

9. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated.

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	10	10
Count of Participants [Participants]	10 100%	10 100%	10 100%

10. Primary Outcome

Title	Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
Description	Subjects will complete a post vaccination anxiety assessment
Time Frame	Day1

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	10	10
Count of Participants [Participants]	10 100%	10 100%	10 100%

11. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	10	10
Count of Participants [Participants]	10 100%	10 100%	10 100%

12. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	10
Count of Participants [Participants]	0 0%	5 50%	6 60%

13. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	10
Count of Participants [Participants]	0 0%	4 40%	3 30%

14. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	9 90%	0 0%	6 60%

15. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	9 90%	0 0%	5 50%

16. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated. One participant did not complete the assessment.

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	9
Count of Participants [Participants]	0 0%	7 70%	8 80%

17. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated. One participant did not complete the assessment.

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	9
Count of Participants [Participants]	0 0%	6 60%	7 70%

18. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated. One participant did not complete the assessment.

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	9	0	10
Count of Participants [Participants]	6 60%	0 0%	8 80%

19. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	7 70%	0 0%	7 70%

20. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	10
Count of Participants [Participants]	0 0%	9 90%	9 90%

21. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	10
Count of Participants [Participants]	0 0%	9 90%	10 100%

22. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated. One participant did not complete the assessment.

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	9
Count of Participants [Participants]	0 0%	10 100%	9 90%

23. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	10
Count of Participants [Participants]	0 0%	10 100%	8 80%

24. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	10
Count of Participants [Participants]	0 0%	10 100%	10 100%

25. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	0	10	10
Count of Participants [Participants]	0 0%	10 100%	10 100%

26. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	9 90%	0 0%	9 90%

27. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participant randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	10 100%	0 0%	9 90%

28. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	7 70%	0 0%	8 80%

29. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	6 60%	0 0%	8 80%

30. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	10 100%	0 0%	9 90%

31. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants randomized to intervention and vaccinated

Arm/Group Title	Buzzy®	Music	Buzzy® and Music
Arm/Group 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. 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.	Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
Measure Participants	10	0	10
Count of Participants [Participants]	9 90%	0 0%	8 80%

Adverse Events

Time Frame	Data were collected for 20 minutes post-vaccination.
Arm/Group Title	Buzzy®		Music		Buzzy® and Music
Arm/Group 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. 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.		Music will be selected and listened to as a distraction before and during vaccination. Music: 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. 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. Music: Music will be selected and listened to as a distraction before and during vaccination.
All Cause Mortality
	Buzzy®		Music		Buzzy® and Music
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Buzzy®		Music		Buzzy® and Music
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Buzzy®		Music		Buzzy® and Music
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		1/10 (10%)		0/10 (0%)
Vascular disorders
Presyncope	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.