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

Duke University

Status: Completed

Conditions: Syncope, Vasovagal

Treatments: Behavioral: Music; Device: Buzzy®

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03533829

PRO00094074

200 2012 53663 0013 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Buzzy®

Active Comparator group

Description:

Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.

Treatment:

Device: Buzzy®

Music

Active Comparator group

Description:

Music will be selected and listened to as a distraction before and during vaccination.

Treatment:

Behavioral: Music

Buzzy® and Music

Active Comparator group

Description:

Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination.

Treatment:

Behavioral: Music

Device: Buzzy®