N/A Completed N=30 Randomized Device Feasibility

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

Syncope, Vasovagal

Source: ClinicalTrials.gov NCT03533829 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcomePrimary: Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination — 10; 0; 10 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination	10; 0; 10	—
PRIMARY Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure	9; 0; 10	—
PRIMARY Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination	0; 10; 10	—
PRIMARY Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination	0; 8; 7	—
PRIMARY Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment	10; 10; 10	—
PRIMARY Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment	10; 10; 10	—
PRIMARY Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.	4; 7; 3	—
PRIMARY Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes	8; 10; 9	—
PRIMARY Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment	10; 10; 10	—
PRIMARY Number of Subjects Who Complete the Post Vaccination Anxiety Assessment	10; 10; 10	—
PRIMARY Number of Subjects Who Complete the Acceptability Assessment	10; 10; 10	—
PRIMARY Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy	0; 5; 6	—
PRIMARY Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive	0; 4; 3	—
PRIMARY Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy	9; 0; 6	—
PRIMARY Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive	9; 0; 5	—
PRIMARY Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy	0; 7; 8	—
PRIMARY Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive	0; 6; 7	—
PRIMARY Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy	6; 0; 8	—
PRIMARY Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive	7; 0; 7	—
PRIMARY Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much	0; 9; 9	—
PRIMARY Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy	0; 9; 10	—
PRIMARY Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable	0; 10; 9	—
PRIMARY Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right	0; 10; 8	—
PRIMARY Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s	0; 10; 10	—
PRIMARY Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like	0; 10; 10	—
PRIMARY Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s	9; 0; 9	—
PRIMARY Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy	10; 0; 9	—
PRIMARY Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable	7; 0; 8	—
PRIMARY Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s	6; 0; 8	—
PRIMARY Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s	10; 0; 9	—
PRIMARY Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again	9; 0; 8	—

Eligibility Criteria

Inclusion Criteria

10 years through 17 years of age
If 10 through 13 years of age, the subject must be receiving at least one vaccine delivered intramuscularly
If 14 through 17 years of age, the subject must be receiving at least two injectable vaccines one of which must be delivered intramuscularly
The parent/guardian must be willing and capable of providing written informed consent for the adolescent and the adolescent must be willing and capable of providing assent.
The subject must be willing to stay for the completion of all study-related activities.
Parent/guardian and adolescent must speak and read English by self-report

Exclusion Criteria

Receipt of investigational or experimental vaccine or medication within the previous two weeks
Receipt of routine injectable medication
Permanent indwelling venous catheter
Blood drawn within the past hour or scheduled for a blood draw during the post-vaccination observation period
Injection of medication during the past hour or scheduled for injection of medication during the observation period.
Cold intolerance or cold urticaria
Raynaud's phenomenon
Sickle cell disease
Inability to hear
Significant visual impairment or blindness
Febrile or acutely ill individuals
Upper arm or shoulder pain or injury
Adolescent or parent/Guardian is an immediate relative of study staff or an employee who is supervised by study staff.
Any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03533829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.