NCT04772755

Presyncope (Syncope) Prevention Study

Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Accepted

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.

Conditions

• Syncope, Vasovagal

Interventions

Type	Name	Description
DEVICE	Buzzy® and Electronic Game	Buzzy® was applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.

Timeline

• Start date: 2021-03-10
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2021-02-26
• Last updated: 2023-08-16
• Results posted: 2023-08-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study