Syncope, VasovagalPS^2NCT04772755
Presyncope (Syncope) Prevention Study
A study testing Buzzy® and Electronic Game in people with Syncope, Vasovagal, run by Duke University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Syncope, Vasovagal
- What is being tested?
- Buzzy® and Electronic Game
- Type of treatment
- Vaccines, Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Mar 2021to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
Duke University
Durham, North Carolina, 27705
About this study
Official title: 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.
- Conditions
- Syncope, Vasovagal
- Being tested
- Buzzy® and Electronic Game
- Keywords
- Adolescent, Child, Buzzy®, Electronic Game, Syncope, Pain Mitigation, Anxiety, Presyncope, Vaccination, Syncope Prevention
- Medical subject headings
- Syncope, Vasovagal, Syncope, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy® and Electronic GameDevice
Buzzy® was applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Buzzy® and Electronic Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1, 20 minutes post vaccination
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1, approximately 20 minutes post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start10 Mar 2021
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Emmanual B Walter, MD, MPH, Principal investigator, Duke UniversityTheresa Harrington, MD, Principal investigator, Centers for Disease Control and PreventionKaren R Broder, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772755
- Sponsor's protocol ID
- Pro00107635
- Acronym
- PS^2
- Status last verified
- Jul 2023
- First submitted
- 24 Feb 2021
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Smith MJ, Harrington TA, Chung RJ, Rountree W, Poniewierski MS, Spreng RL, Broder KR, Kroger A, McNeil MM, Marquez P, Walter EB. Preventing Postvaccination Presyncope and Syncope in Adolescents: A Randomized Controlled Trial of a Clinic-Based Intervention. J Pediatr. 2026 Jun;293:115035. doi: 10.1016/j.jpeds.2026.115035. Epub 2026 Feb 13.
PubMed 41692229
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions
- ClinicalTrials.gov ID
- NCT04772755
- Acronym / sponsor ID
- PS^2 / Pro00107635
- Conditions
- Syncope, Vasovagal
- Keywords
- Adolescent, Child, Buzzy®, Electronic Game, Syncope, Pain Mitigation, Anxiety, Presyncope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Buzzy® and Electronic GameBuzzy® 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buzzy® and Electronic GameBuzzy® was applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination. | Device | Buzzy ® and Electronic Game |
Primary outcome
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.
12 secondary outcomes
Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.
Time frame: 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)
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
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
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41692229Smith MJ, Harrington TA, Chung RJ, Rountree W, Poniewierski MS, Spreng RL, Broder KR, Kroger A, McNeil MM, Marquez P, Walter EB. Preventing Postvaccination Presyncope and Syncope in Adolescents: A Randomized Controlled Trial of a Clinic-Based Intervention. J Pediatr. 2026 Jun;293:115035. doi: 10.1016/j.jpeds.2026.115035. Epub 2026 Feb 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanual B Walter, MD, MPH principal investigator
Duke University
Theresa Harrington, MD principal investigator
Centers for Disease Control and Prevention
Karen R Broder, MD principal investigator
Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy® and Electronic Game in people with Syncope, Vasovagal, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups. (time frame: Day 1, 20 minutes post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023; AzTrials last refreshed its copy on 27 Oct 2026.