Syncope, Vasovagal
Conditions
Keywords
vaccination, pre-syncope, syncope prevention
Brief summary
This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to being used in a larger study to assess the effectiveness of the interventions in preventing post-vaccination presyncope and syncope. Feasibility will be assessed according to study staff ability to successfully administer the protocol specified clinic-based interventions and per both study staff and healthcare provider responses to written feasibility assessments. Acceptability will be assessed according to the participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed per participant written self-report to standardized survey questions.
Interventions
DEVICEBuzzy®
Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.
BEHAVIORALMusic
Music will be selected and listened to as a distraction before and during vaccination.
Sponsors
Centers for Disease Control and Prevention
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. 10 years through 17 years of age 2. If 10 through 13 years of age, the subject must be receiving at least one vaccine delivered intramuscularly 3. If 14 through 17 years of age, the subject must be receiving at least two injectable vaccines one of which must be delivered intramuscularly 4. The parent/guardian must be willing and capable of providing written informed consent for the adolescent and the adolescent must be willing and capable of providing assent. 5. The subject must be willing to stay for the completion of all study-related activities. 6. Parent/guardian and adolescent must speak and read English by self-report
Exclusion criteria
1. Receipt of investigational or experimental vaccine or medication within the previous two weeks 2. Receipt of routine injectable medication 3. Permanent indwelling venous catheter 4. Blood drawn within the past hour or scheduled for a blood draw during the post-vaccination observation period 5. Injection of medication during the past hour or scheduled for injection of medication during the observation period. 6. Cold intolerance or cold urticaria 7. Raynaud's phenomenon 8. Sickle cell disease 9. Inability to hear 10. Significant visual impairment or blindness 11. Febrile or acutely ill individuals 12. Upper arm or shoulder pain or injury 13. Adolescent or parent/Guardian is an immediate relative of study staff or an employee who is supervised by study staff. 14. Any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable | Day1 | Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations |
| Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy | Day1 | Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject |
| Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination | Day1 | Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination. |
| Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure | Day1 | Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure. |
| Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination | Day1 | Music will be played over speakers for a minimum of 3 minutes prior to vaccination |
| Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination | Day1 | Music will be played over speakers through the 10 minute post vaccination pain assessment |
| Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment | Day1 | Subjects will be asked to complete an anxiety assessment prior to vaccination |
| Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment | Day1 | Subjects will be asked to complete a needle phobia assessment pre-vaccination |
| Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute. | Day1 | Subjects will complete a post vaccination pain assessment within one minute of their final vaccination |
| Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes | Day1 | Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination |
| Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment | Day1 | Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s |
| Number of Subjects Who Complete the Post Vaccination Anxiety Assessment | Day1 | Subjects will complete a post vaccination anxiety assessment |
| Number of Subjects Who Complete the Acceptability Assessment | Day1 | Subjects will be given a questionnaire about the acceptability of their intervention. |
| Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive | Day1 | Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject |
| Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy | Day1 | Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject |
| Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive | Day1 | Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject |
| Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy | Day1 | Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject |
| Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive | Day1 | Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject |
| Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy | Day1 | Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject |
| Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive | Day1 | Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject |
| Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much | Day1 | Subjects will complete a survey about the acceptability of the music intervention during their vaccinations |
| Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy | Day1 | Subjects will complete a survey about the acceptability of the music intervention during their vaccinations |
| Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable | Day1 | Subjects will complete a survey about the acceptability of the music intervention during their vaccinations |
| Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right | Day1 | Subjects will complete a survey about the acceptability of the music intervention during their vaccinations |
| Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s | Day1 | Subjects will complete a survey about the acceptability of the music intervention during their vaccinations |
| Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like | Day1 | Subjects will complete a survey about the acceptability of the music intervention during their vaccinations |
| Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s | Day1 | Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations |
| Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy | Day1 | Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations |
| Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s | Day1 | Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations |
| Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s | Day1 | Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations |
| Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again | Day1 | Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| 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. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Buzzy® | Music | Buzzy® and Music | Total |
|---|---|---|---|---|
| Age, Customized 10-13 years | 8 Participants | 6 Participants | 10 Participants | 24 Participants |
| Age, Customized 14-17 years | 2 Participants | 4 Participants | 0 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 10 Participants | 10 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants | 2 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Race More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 7 Participants | 8 Participants | 7 Participants | 22 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 10 Participants | 30 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 7 Participants | 6 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 1 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive | 9 Participants |
| Music | Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive | 0 Participants |
| Buzzy® and Music | Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive | 5 Participants |
Primary
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy | 9 Participants |
| Music | Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy | 0 Participants |
| Buzzy® and Music | Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy | 6 Participants |
Primary
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive | 0 Participants |
| Music | Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive | 4 Participants |
| Buzzy® and Music | Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive | 3 Participants |
Primary
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy | 0 Participants |
| Music | Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy | 5 Participants |
| Buzzy® and Music | Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy | 6 Participants |
Primary
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive | 7 Participants |
| Music | Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive | 0 Participants |
| Buzzy® and Music | Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive | 7 Participants |
Primary
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Time frame: Day1
Population: Participant randomized to intervention and vaccinated. One participant did not complete the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy | 6 Participants |
| Music | Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy | 0 Participants |
| Buzzy® and Music | Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy | 8 Participants |
Primary
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time frame: Day1
Population: Participant randomized to intervention and vaccinated. One participant did not complete the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive | 0 Participants |
| Music | Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive | 6 Participants |
| Buzzy® and Music | Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive | 7 Participants |
Primary
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Time frame: Day1
Population: Participant randomized to intervention and vaccinated. One participant did not complete the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy | 0 Participants |
| Music | Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy | 7 Participants |
| Buzzy® and Music | Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy | 8 Participants |
Primary
Number of Subjects Who Complete the Acceptability Assessment
Subjects will be given a questionnaire about the acceptability of their intervention.
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Complete the Acceptability Assessment | 10 Participants |
| Music | Number of Subjects Who Complete the Acceptability Assessment | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Complete the Acceptability Assessment | 10 Participants |
Primary
Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
Subjects will complete a post vaccination anxiety assessment
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Complete the Post Vaccination Anxiety Assessment | 10 Participants |
| Music | Number of Subjects Who Complete the Post Vaccination Anxiety Assessment | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Complete the Post Vaccination Anxiety Assessment | 10 Participants |
Primary
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes
Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination
Time frame: Day1
Population: Participants randomized to intervention and vaccinated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes | 8 Participants |
| Music | Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes | 9 Participants |
Primary
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.
Subjects will complete a post vaccination pain assessment within one minute of their final vaccination
Time frame: Day1
Population: Participants randomized to intervention and vaccinated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute. | 4 Participants |
| Music | Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute. | 7 Participants |
| Buzzy® and Music | Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute. | 3 Participants |
Primary
Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment
Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s
Time frame: Day1
Population: Participants randomized to intervention and vaccinated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment | 10 Participants |
| Music | Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment | 10 Participants |
Primary
Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
Subjects will be asked to complete an anxiety assessment prior to vaccination
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment | 10 Participants |
| Music | Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment | 10 Participants |
Primary
Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
Subjects will be asked to complete a needle phobia assessment pre-vaccination
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment | 10 Participants |
| Music | Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment | 10 Participants |
Primary
Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s | 9 Participants |
| Music | Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s | 0 Participants |
| Buzzy® and Music | Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s | 9 Participants |
Primary
Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy | 0 Participants |
| Music | Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy | 9 Participants |
| Buzzy® and Music | Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy | 10 Participants |
Primary
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable | 7 Participants |
| Music | Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable | 0 Participants |
| Buzzy® and Music | Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable | 8 Participants |
Primary
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy | 10 Participants |
| Music | Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy | 0 Participants |
| Buzzy® and Music | Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy | 9 Participants |
Primary
Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time frame: Day1
Population: Participants randomized to intervention and vaccinated. One participant did not complete the assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable | 0 Participants |
| Music | Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable | 9 Participants |
Primary
Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like | 0 Participants |
| Music | Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like | 10 Participants |
Primary
Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right | 0 Participants |
| Music | Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right | 8 Participants |
Primary
Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination | 10 Participants |
| Music | Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination | 0 Participants |
| Buzzy® and Music | Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination | 10 Participants |
Primary
Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure
Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure | 9 Participants |
| Music | Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure | 0 Participants |
| Buzzy® and Music | Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure | 10 Participants |
Primary
Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination
Music will be played over speakers through the 10 minute post vaccination pain assessment
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination | 0 Participants |
| Music | Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination | 8 Participants |
| Buzzy® and Music | Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination | 7 Participants |
Primary
Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination
Music will be played over speakers for a minimum of 3 minutes prior to vaccination
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination | 0 Participants |
| Music | Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination | 10 Participants |
Primary
Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time frame: Day1
Population: Participant randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much | 0 Participants |
| Music | Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much | 9 Participants |
| Buzzy® and Music | Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much | 9 Participants |
Primary
Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s | 6 Participants |
| Music | Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s | 0 Participants |
| Buzzy® and Music | Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s | 8 Participants |
Primary
Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s | 10 Participants |
| Music | Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s | 0 Participants |
| Buzzy® and Music | Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s | 9 Participants |
Primary
Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s | 0 Participants |
| Music | Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s | 10 Participants |
| Buzzy® and Music | Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s | 10 Participants |
Primary
Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Time frame: Day1
Population: Participants randomized to intervention and vaccinated
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buzzy® | Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again | 9 Participants |
| Music | Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again | 0 Participants |
| Buzzy® and Music | Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again | 8 Participants |