Status:
COMPLETED
Presyncope (Syncope) Prevention Study
Lead Sponsor:
Duke University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Syncope, Vasovagal
Eligibility:
All Genders
10-14 years
Phase:
NA
Brief Summary
This study was a prospective, randomized clinical trial that was conducted in adolescents (10 through 14 years of age) receiving at least one recommended intramuscularly administered vaccine to evalua...
Eligibility Criteria
Inclusion
- 10 years through 14 years of age
- The subject must be receiving at least one vaccine 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
- Parent/guardian must be willing to let their child select an electronic game to play during the study
Exclusion
- 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
- Significant visual impairment or blindness
- Significant auditory impairment or deafness
- Febrile (\>38.0°C) or acutely ill individuals
- Upper arm or shoulder pain or injury
- Video game-induced seizures
- 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
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT04772755
Start Date
March 10 2021
End Date
June 15 2022
Last Update
August 16 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
2
Duke University
Durham, North Carolina, United States, 27705