Presyncope (Syncope) Prevention Study
Presyncope (Syncope) Prevention Study
This study is a prospective, randomized clinical trial that will be conducted in adolescents
 (10 through 14 years of age) receiving at least one recommended intramuscularly administered
 vaccine to evaluate the efficacy and acceptability of using two different, simultaneously
 administered interventions that might prevent post-vaccination presyncope, and by extension
 syncope. The two interventions to be evaluated together are Buzzy®, which is a medical device
 designed to reduce vaccination pain, and an electronic game. The investigators will evaluate
 both interventions when administered simultaneously (Buzzy® and electronic game). The
 investigators will enroll approximately 340 subjects into this study. Eligible adolescents
 will be randomized (1:1) to either the intervention or control group: 1) intervention (Buzzy®
 and electronic game); or 2) control (usual care) to assess for acceptability and efficacy.
 Detailed data will be collected and described from study participants including demographics,
 medical history, baseline anxiety, and needle phobia. Participants will be observed for 20
 minutes following receipt of vaccines and reassessed for post-vaccination anxiety, immediate
 and subsequent post-vaccination pain (within 1 minute and at 10 minutes), and the occurrence
 of witnessed syncope or presyncope, and presyncopal symptoms as rated by the modified Blood
 Donation Reactions Inventory (BDRI). Participants will also be asked to assess their
 acceptability of the intervention.
Inclusion Criteria:

 1. 10 years through 14 years of age

 2. The subject must be receiving at least one vaccine delivered intramuscularly

 3. 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.

 4. The subject must be willing to stay for the completion of all study-related
 activities.

 5. Parent/guardian and adolescent must speak and read English by self-report

 6. Parent/guardian must be willing to let their child select an electronic game to play
 during the study

 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. Significant visual impairment or blindness

 10. Significant auditory impairment or deafness

 11. Febrile (>38.0°C) or acutely ill individuals

 12. Upper arm or shoulder pain or injury

 13. Video game-induced seizures

 14. Adolescent or parent/Guardian is an immediate relative of study staff or an employee
 who is supervised by study staff.

 15. 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