Adults 10 to 14, any sex, with Syncope, Vasovagal. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups.Primary· Day 1, 20 minutes post vaccination
Subjects were asked to complete a presyncope symptoms assessment (Modified BDRI: Blood Donations Reactions Inventory) at 20 minutes post vaccination. The number of adolescents with presyncope or syncope as determined by the modified BRDR or witnessed presyncope or syncope.
Group
Value
95% CI
Usual Care
80
Buzzy ® and Electronic Game
59
Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.Secondary· Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)
Subjects completed the Youth Momentary Anxiety Checklist pre vaccination and 20 minutes post vaccination. Subjects completed a Likert scale anxiety metric \[The Youth Momentary Anxiety Checklist (YMAC)\], with 12 emotions ranging from 1-4 (1 is best/no anxiety and 4 is worse/highest anxiety) and 1 figure ranging from 1-5 (lowest to highest anxiety) and these 13 scores are added together for analysis. The best/lowest score is a 13 and the highest score is a 53, with the pre-vaccination total score minus the post-vaccination total score as the outcome of interest.
Group
Value
95% CI
Usual Care
28
Buzzy ® and Electronic Game
28
Usual Care
121
Buzzy ® and Electronic Game
123
Usual Care
14
Buzzy ® and Electronic Game
13
Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety.Secondary· Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)
Subjects were asked to complete the Youth Momentary Anxiety Checklist pre vaccination and 20 minutes post vaccination. Subjects completed a Likert scale anxiety metric \[The Youth Momentary Anxiety Checklist (YMAC)\], with 12 emotions ranging from 1-4 (1 is best/no anxiety and 4 is worse/highest anxiety) and 1 figure ranging from 1-5 (lowest to highest anxiety) and these 13 scores are added together for analysis. The best/lowest score is a 13 and the highest score is a 53, with the pre-vaccination total score minus the post-vaccination total score as the outcome of interest.
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or DislikeSecondary· Day 1, approximately 20 minutes post vaccination
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
How much do you like having Buzzy on your arm(s) during the shot(s)?
Group
Value
95% CI
Buzzy ® and Electronic Game
4
Buzzy ® and Electronic Game
16
Buzzy ® and Electronic Game
28
Buzzy ® and Electronic Game
35
How much do you like playing a game during the shot(s)?
Group
Value
95% CI
Buzzy ® and Electronic Game
1
Buzzy ® and Electronic Game
0
Buzzy ® and Electronic Game
19
Buzzy ® and Electronic Game
22
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or EasySecondary· Day 1, approximately 20 minutes post vaccination
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
How difficult or easy was holding or having Buzzy held on your arm(s) during the shot(s)?
Group
Value
95% CI
Buzzy ® and Electronic Game
1
Buzzy ® and Electronic Game
8
Buzzy ® and Electronic Game
15
Buzzy ® and Electronic Game
23
How difficult or easy was it to select and play the game?
Group
Value
95% CI
Buzzy ® and Electronic Game
2
Buzzy ® and Electronic Game
3
Buzzy ® and Electronic Game
7
Buzzy ® and Electronic Game
21
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or UncomfortableSecondary· Day 1, approximately 20 minutes post vaccination
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
How comfortable or uncomfortable was Buzzy on your arm(s) during the shot(s)?
Group
Value
95% CI
Buzzy ® and Electronic Game
11
Buzzy ® and Electronic Game
34
Buzzy ® and Electronic Game
16
Buzzy ® and Electronic Game
47
How comfortable or uncomfortable were you playing a game when receiving shots?
Group
Value
95% CI
Buzzy ® and Electronic Game
4
Buzzy ® and Electronic Game
5
Buzzy ® and Electronic Game
12
Buzzy ® and Electronic Game
37
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 16 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04772755.