N/A N=338 Randomized Prevention

Presyncope (Syncope) Prevention Study

Syncope, Vasovagal

Bottom Line

View on ClinicalTrials.gov: NCT04772755 ↗

Enrolled (actual)

338

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups. — 80; 59 Participants — p=0.0249

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Buzzy® and Electronic Game (Device)
Age: Pediatric · 10+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups.	80; 59	0.0249 sig
SECONDARY Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.	28; 28; 121; 123; 14; 13	0.8918
SECONDARY Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety.	5.69; 5.23	0.6587
SECONDARY Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at ≤ 1 Minute Following Vaccination.	3.26; 2.51	0.0059 sig
SECONDARY Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.	136; 124	0.1647
SECONDARY Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.	77; 53	0.0090 sig
SECONDARY Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at (Approximately) 10 Minutes Following Vaccination.	1.54; 1.09	0.0273 sig
SECONDARY Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.	84; 65	0.0458 sig
SECONDARY Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.	30; 19	0.0976
SECONDARY Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike	4; 16; 28; 35; 76; 6	—
SECONDARY Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy	1; 8; 15; 23; 111; 7	—
SECONDARY Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable	11; 34; 16; 47; 53; 4	—
SECONDARY Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no	113; 35; 17; 147; 10; 8	—

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

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 Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04772755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.