Presyncope (Syncope) Prevention Study (PS^2)

July 25, 2023 updated by: Duke University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
338

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups.
Time Frame: 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.
Day 1, 20 minutes post vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.
Time Frame: 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.
Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)
Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety.
Time Frame: 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.
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.
Time Frame: Day 1, ≤ 1 minute after 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.
Time Frame: Day 1, ≤ 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.
Time Frame: Day 1, ≤ 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.
Time Frame: Day 1, (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.
Time Frame: Day 1, (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.
Time Frame: Day 1, (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
Time Frame: Day 1, approximately 20 minutes post vaccination
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
Time Frame: Day 1, approximately 20 minutes post vaccination
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
Time Frame: Day 1, approximately 20 minutes post vaccination
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
Time Frame: Day 1, approximately 20 minutes post vaccination
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
Day 1, approximately 20 minutes post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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