Trial Outcomes & Findings for Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study (NCT NCT03533829)
NCT ID: NCT03533829
Last Updated: 2019-08-16
Results Overview
Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Day1
Results posted on
2019-08-16
Participant Flow
Participant milestones
| Measure |
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.
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.
Music: Music will be selected and listened to as a distraction before and during vaccination.
|
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.
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 Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
Baseline characteristics by cohort
| Measure |
Buzzy®
n=10 Participants
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
n=10 Participants
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® and Music
n=10 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
10-13 years
|
8 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
24 Participants
n=31 Participants
|
|
Age, Customized
14-17 years
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
29 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
7 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Other race
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
30 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
|
10 Participants
|
0 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure
|
9 Participants
|
0 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Music will be played over speakers for a minimum of 3 minutes prior to vaccination
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination
|
0 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Music will be played over speakers through the 10 minute post vaccination pain assessment
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination
|
0 Participants
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Subjects will be asked to complete an anxiety assessment prior to vaccination
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
|
10 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Subjects will be asked to complete a needle phobia assessment pre-vaccination
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
|
10 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated.
Subjects will complete a post vaccination pain assessment within one minute of their final vaccination
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.
|
4 Participants
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated.
Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes
|
8 Participants
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated.
Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment
|
10 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Subjects will complete a post vaccination anxiety assessment
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
|
10 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Subjects will be given a questionnaire about the acceptability of their intervention.
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Complete the Acceptability Assessment
|
10 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
|
0 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
|
0 Participants
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
|
9 Participants
|
0 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
|
9 Participants
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated. One participant did not complete the assessment.
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=9 Participants
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.
|
|---|---|---|---|
|
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
|
0 Participants
|
7 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated. One participant did not complete the assessment.
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=9 Participants
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.
|
|---|---|---|---|
|
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
|
0 Participants
|
6 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated. One participant did not complete the assessment.
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Outcome measures
| Measure |
Buzzy®
n=9 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
|
6 Participants
|
0 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
|
7 Participants
|
0 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much
|
0 Participants
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy
|
0 Participants
|
9 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated. One participant did not complete the assessment.
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=9 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable
|
0 Participants
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right
|
0 Participants
|
10 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s
|
0 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Outcome measures
| Measure |
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.
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
n=10 Participants
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like
|
0 Participants
|
10 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s
|
9 Participants
|
0 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participant randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy
|
10 Participants
|
0 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable
|
7 Participants
|
0 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s
|
6 Participants
|
0 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s
|
10 Participants
|
0 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Day1Population: Participants randomized to intervention and vaccinated
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Outcome measures
| Measure |
Buzzy®
n=10 Participants
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
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® and Music
n=10 Participants
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.
|
|---|---|---|---|
|
Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again
|
9 Participants
|
0 Participants
|
8 Participants
|
Adverse Events
Buzzy®
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Music
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Buzzy® and Music
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Buzzy®
n=10 participants at risk
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
n=10 participants at risk
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® and Music
n=10 participants at risk
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.
|
|---|---|---|---|
|
Vascular disorders
Presyncope
|
0.00%
0/10 • Data were collected for 20 minutes post-vaccination.
|
10.0%
1/10 • Number of events 1 • Data were collected for 20 minutes post-vaccination.
|
0.00%
0/10 • Data were collected for 20 minutes post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place