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

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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Device Feasibility
Condition Syncope, Vasovagal
Interventions Device: Buzzy®
Behavioral: Music
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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
Arm/Group Title Buzzy® Music Buzzy® and Music Total
Hide 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 Number of Baseline Participants 10 10 10 30
Hide Baseline Analysis Population Description
Adolescents randomized to intervention
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
10-13 years
8
  80.0%
6
  60.0%
10
 100.0%
24
  80.0%
14-17 years
2
  20.0%
4
  40.0%
0
   0.0%
6
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
Female
3
  30.0%
3
  30.0%
4
  40.0%
10
  33.3%
Male
7
  70.0%
7
  70.0%
6
  60.0%
20
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
Hispanic or Latino
1
  10.0%
0
   0.0%
0
   0.0%
1
   3.3%
Not Hispanic or Latino
9
  90.0%
10
 100.0%
10
 100.0%
29
  96.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 10 participants 10 participants 10 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  20.0%
2
  20.0%
2
  20.0%
6
  20.0%
White
7
  70.0%
8
  80.0%
7
  70.0%
22
  73.3%
More than one race
0
   0.0%
0
   0.0%
1
  10.0%
1
   3.3%
Other race
1
  10.0%
0
   0.0%
0
   0.0%
1
   3.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 10 participants 30 participants
10
 100.0%
10
 100.0%
10
 100.0%
30
 100.0%
1.Primary Outcome
Title Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
Hide Description Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
0
10
 100.0%
2.Primary Outcome
Title Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure
Hide Description Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
0
10
 100.0%
3.Primary Outcome
Title Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination
Hide Description Music will be played over speakers for a minimum of 3 minutes prior to vaccination
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
10
 100.0%
10
 100.0%
4.Primary Outcome
Title Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination
Hide Description Music will be played over speakers through the 10 minute post vaccination pain assessment
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
8
  80.0%
7
  70.0%
5.Primary Outcome
Title Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
Hide Description Subjects will be asked to complete an anxiety assessment prior to vaccination
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
10
 100.0%
10
 100.0%
6.Primary Outcome
Title Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
Hide Description Subjects will be asked to complete a needle phobia assessment pre-vaccination
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
10
 100.0%
10
 100.0%
7.Primary Outcome
Title Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.
Hide Description Subjects will complete a post vaccination pain assessment within one minute of their final vaccination
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated.
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
4
  40.0%
7
  70.0%
3
  30.0%
8.Primary Outcome
Title Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes
Hide Description Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated.
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
10
 100.0%
9
  90.0%
9.Primary Outcome
Title Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment
Hide Description Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated.
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
10
 100.0%
10
 100.0%
10.Primary Outcome
Title Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
Hide Description Subjects will complete a post vaccination anxiety assessment
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
10
 100.0%
10
 100.0%
11.Primary Outcome
Title Number of Subjects Who Complete the Acceptability Assessment
Hide Description Subjects will be given a questionnaire about the acceptability of their intervention.
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
10
 100.0%
10
 100.0%
12.Primary Outcome
Title Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Hide Description Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
5
  50.0%
6
  60.0%
13.Primary Outcome
Title Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Hide Description Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
4
  40.0%
3
  30.0%
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
Hide Description Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
0
6
  60.0%
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
Hide Description Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
0
5
  50.0%
16.Primary Outcome
Title Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Hide Description Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated. One participant did not complete the assessment.
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
7
  70.0%
8
  88.9%
17.Primary Outcome
Title Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Hide Description Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated. One participant did not complete the assessment.
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
6
  60.0%
7
  77.8%
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
Hide Description Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated. One participant did not complete the assessment.
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 9 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
6
  66.7%
0
8
  80.0%
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
Hide Description Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
0
7
  70.0%
20.Primary Outcome
Title Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much
Hide Description Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
9
  90.0%
9
  90.0%
21.Primary Outcome
Title Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy
Hide Description Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
9
  90.0%
10
 100.0%
22.Primary Outcome
Title Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable
Hide Description Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated. One participant did not complete the assessment.
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
10
 100.0%
9
 100.0%
23.Primary Outcome
Title Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right
Hide Description Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
10
 100.0%
8
  80.0%
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
Hide Description Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
10
 100.0%
10
 100.0%
25.Primary Outcome
Title Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like
Hide Description Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 0 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
0
10
 100.0%
10
 100.0%
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
Hide Description Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
0
9
  90.0%
27.Primary Outcome
Title Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy
Hide Description Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participant randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
0
9
  90.0%
28.Primary Outcome
Title Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable
Hide Description Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
7
  70.0%
0
8
  80.0%
29.Primary Outcome
Title Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s
Hide Description Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
6
  60.0%
0
8
  80.0%
30.Primary Outcome
Title Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s
Hide Description Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
0
9
  90.0%
31.Primary Outcome
Title Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again
Hide Description Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time Frame Day1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants randomized to intervention and vaccinated
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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.

Overall Number of Participants Analyzed 10 0 10
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
0
8
  80.0%
Time Frame Data were collected for 20 minutes post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buzzy® Music Buzzy® and Music
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Buzzy® Music Buzzy® and Music
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Buzzy® Music Buzzy® and Music
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/10 (10.00%)      0/10 (0.00%)    
Vascular disorders       
Presyncope * [1]  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Air conditioning in room not working. The patient felt better after being fanned for five minutes. Symptoms lasted between 1 and 5 minutes.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristen Gunnell
Organization: Duke Vaccine and Trials Unit
Phone: 9196848891
EMail: kristen.gunnell@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03533829     History of Changes
Other Study ID Numbers: PRO00094074
200 2012 53663 0013 ( Other Grant/Funding Number: CDC )
First Submitted: May 11, 2018
First Posted: May 23, 2018
Results First Submitted: July 9, 2019
Results First Posted: August 16, 2019
Last Update Posted: August 16, 2019