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Completed

NCT Number: NCT04772755

Presyncope (Syncope) Prevention Study

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.

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Key information

Conditions

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

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centers for Disease Control and Prevention, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Acronym: PS^2

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2021
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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