Clinical trial NCT04772755: Presyncope (Syncope) Prevention Study
Official title: Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope, Vasovagal
Keywords: Adolescent
Child
Buzzy®
Electronic Game
Syncope
Pain Mitigation
Anxiety
Presyncope
Vaccination
Syncope Prevention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-02-26
Enrollment: 338
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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 evaluated together were Buzzy®, which is a medical device designed to reduce vaccination pain, and an electronic game. The investigators evaluated both interventions when administered simultaneously (Buzzy® and electronic game). The investigators enrolled approximately 340 subjects into this study. Eligible adolescents were 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 were collected and described from study participants including demographics, medical history, baseline generalized and state anxiety, and needle phobia. Participants were observed for 20 minutes following receipt of vaccines and reassessed for post-vaccination state 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 were asked to assess their acceptability of the intervention.


Eligibility 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

Primary outcomes:
measure: Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups.
timeFrame: Day 1, 20 minutes post vaccination
Secondary outcomes:
measure: Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.
timeFrame: Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)
measure: Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety.
timeFrame: Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)
measure: Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at ≤ 1 Minute Following Vaccination.
timeFrame: Day 1, ≤ 1 minute after vaccination
measure: Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.
timeFrame: Day 1, ≤ 1 minute following vaccination
measure: Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.
timeFrame: Day 1, ≤ 1 minute following vaccination
measure: Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at (Approximately) 10 Minutes Following Vaccination.
timeFrame: Day 1, (approximately) 10 minutes following vaccination
measure: Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.
timeFrame: Day 1, (approximately) 10 minutes following vaccination
measure: Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.
timeFrame: Day 1, (approximately) 10 minutes following vaccination
measure: Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
timeFrame: Day 1, approximately 20 minutes post vaccination
measure: Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
timeFrame: Day 1, approximately 20 minutes post vaccination
measure: Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
timeFrame: Day 1, approximately 20 minutes post vaccination
measure: Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
timeFrame: Day 1, approximately 20 minutes post vaccination
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 University
name: Emmanual B Walter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Theresa Harrington, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centers for Disease Control and Prevention
name: Karen R Broder, MD
role: PRINCIPAL_INVESTIGATOR
References: