Presyncope (Syncope) Prevention Study (PS^2)

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

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.

Study Overview

• Status: Completed
• Conditions: Syncope, Vasovagal
• Intervention / Treatment: Device: Buzzy® and Electronic Game

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30333
      • Centers for Disease Control and Prevention
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Participants received usual care that followed administration of a vaccine and a 20 minute post vaccination observation period.
Experimental: Buzzy ® and Electronic Game; 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; Buzzy® was applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.	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.	Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)
Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety.	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.	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.	Subjects were asked to complete a pain assessment (The Wong-Baker Faces Pain Scale©) ≤ 1 minute after vaccination. The Wong-Baker Faces Pain Scale is a Likert scale with 6 levels (0,2,4,6,8,10) where 0 is no pain and 10 is the most pain.	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.	Subjects were asked to complete a pain assessment (The Wong-Baker Faces Pain Scale©) ≤ 1 minute after vaccination. The Wong-Baker Faces Pain Scale is a Likert scale with 6 levels (0,2,4,6,8,10) where 0 is no pain and 10 is the most pain.	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.	Subjects were asked to complete a pain assessment (The Wong-Baker Faces Pain Scale©) ≤ 1 minute after vaccination. The Wong-Baker Faces Pain Scale is a Likert scale with 6 levels (0,2,4,6,8,10) where 0 is no pain and 10 is the most pain.	Day 1, ≤ 1 minute following vaccination
Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at (Approximately) 10 Minutes Following Vaccination.	Subjects were asked to complete a pain assessment (The Wong-Baker Faces Pain Scale©) 10 minutes after vaccination. The Wong-Baker Faces Pain Scale is a Likert scale with 6 levels (0,2,4,6,8,10) where 0 is no pain and 10 is the most pain.	Day 1, (approximately) 10 minutes following vaccination
Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.	Subjects were asked to complete a pain assessment (The Wong-Baker Faces Pain Scale©) 10 minutes after vaccination. The Wong-Baker Faces Pain Scale is a Likert scale with 6 levels (0,2,4,6,8,10) where 0 is no pain and 10 is the most pain.	Day 1, (approximately) 10 minutes following vaccination
Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.	Subjects were asked to complete a pain assessment (The Wong-Baker Faces Pain Scale©) 10 minutes after vaccination. The Wong-Baker Faces Pain Scale is a Likert scale with 6 levels (0,2,4,6,8,10) where 0 is no pain and 10 is the most pain.	Day 1, (approximately) 10 minutes following vaccination
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike	The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.	Day 1, approximately 20 minutes post vaccination
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy	The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.	Day 1, approximately 20 minutes post vaccination
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable	The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.	Day 1, approximately 20 minutes post vaccination
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no	The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.	Day 1, approximately 20 minutes post vaccination

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Karen R Broder, MD, Centers for Disease Control and Prevention; Principal Investigator: Emmanual B Walter, MD, MPH, Duke University; Principal Investigator: Theresa Harrington, MD, Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent; Child; Anxiety; Vaccination; Syncope; Presyncope; Buzzy®; Electronic Game; Pain Mitigation; Syncope Prevention
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: Pro00107635

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No