Clinical trial NCT03533829: Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
Official title: Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope, Vasovagal
Keywords: vaccination
pre-syncope
syncope prevention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2018-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
timeFrame: Day1
measure: Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure
timeFrame: Day1
measure: Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination
timeFrame: Day1
measure: Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination
timeFrame: Day1
measure: Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
timeFrame: Day1
measure: Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
timeFrame: Day1
measure: Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.
timeFrame: Day1
measure: Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes
timeFrame: Day1
measure: Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment
timeFrame: Day1
measure: Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
timeFrame: Day1
measure: Number of Subjects Who Complete the Acceptability Assessment
timeFrame: Day1
measure: Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
timeFrame: Day1
measure: Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
timeFrame: Day1
measure: Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
timeFrame: Day1
measure: Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
timeFrame: Day1
measure: Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
timeFrame: Day1
measure: Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
timeFrame: Day1
measure: Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
timeFrame: Day1
measure: Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
timeFrame: Day1
measure: Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much
timeFrame: Day1
measure: Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy
timeFrame: Day1
measure: Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable
timeFrame: Day1
measure: Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right
timeFrame: Day1
measure: Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s
timeFrame: Day1
measure: Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like
timeFrame: Day1
measure: Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s
timeFrame: Day1
measure: Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy
timeFrame: Day1
measure: Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable
timeFrame: Day1
measure: Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s
timeFrame: Day1
measure: Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s
timeFrame: Day1
measure: Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again
timeFrame: Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Centers for Disease Control and Prevention
state: Georgia
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke Univeristy
name: Emmanuel "Chip" B Walter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Theresa Harrington, MD, MPH&TM
role: PRINCIPAL_INVESTIGATOR
References: