Presyncope (Syncope) Prevention Study

NCT04772755 | Completed Results FDA Device

• 1 other identifier: Pro00107635
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 2

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.

Conditions

Syncope, Vasovagal

Keywords

Adolescent; Child; Buzzy®; Electronic Game; Syncope; Pain Mitigation; Anxiety; Presyncope; Vaccination; Syncope Prevention

Outcome Measures

Primary Outcomes (1)

• Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups.

  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.

  Day 1, 20 minutes post vaccination

Secondary Outcomes (12)

• Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.

  Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)

• Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety.

  Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)

• Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at ≤ 1 Minute Following Vaccination.

  Day 1, ≤ 1 minute after vaccination

• Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.

  Day 1, ≤ 1 minute following vaccination

• Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.

  Day 1, ≤ 1 minute following vaccination

Study Arms (2)

Usual Care

NO INTERVENTION

Participants received usual care that followed administration of a vaccine and a 20 minute post vaccination observation period.

Buzzy ® and Electronic Game

EXPERIMENTAL

Buzzy® was applied to the arm receiving vaccination for 30-60 seconds prior to vaccination and removed following vaccination. For the electronic game, participants were instructed to select a game from a prepopulated list of games on a tablet provided by the study team and then played that game for a specified amount of time before, during and after the vaccination administration.

Device: Buzzy® and Electronic Game

Interventions

Buzzy® and Electronic Game DEVICE

Buzzy® was applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.

Buzzy ® and Electronic Game

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Centers for Disease Control and Prevention

Atlanta, Georgia, 30333, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Syncope, Vasovagal; Syncope; Anxiety Disorders

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: Emmanuel B Walter, MD, MPH
• Organization: Duke University

chip.walter@duke.edu

919-620-5346

Study Officials

• Emmanual B Walter, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

• Theresa Harrington, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Karen R Broder, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: February 26, 2021
• Study Start: March 10, 2021
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)