Durham, North Carolina 27705

  • Syncope, Vasovagal

Purpose:

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.


Criteria:

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


NCT ID:

NCT04772755


Primary Contact:

Principal Investigator
Emmanual B Walter, MD, MPH
Duke University

Emmanuel B Walter, MD, MPH
Phone: 919-620-5346
Email: chip.walter@duke.edu


Backup Contact:

Email: grace.davis@duke.edu
Grace N Davis, MS
Phone: 919-660-1354


Location Contact:

Durham, North Carolina 27705
United States

Grace N Davis, MS
Phone: 919-660-1354
Email: grace.davis@duke.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 16, 2021

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