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Presyncope (Syncope) Prevention Study (PS^2)

Primary Purpose

Syncope, Vasovagal

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Buzzy® and Electronic Game

About this trial

This is an interventional prevention trial for Syncope, Vasovagal focused on measuring Adolescent, Child, Buzzy®, Electronic Game, Syncope, Pain Mitigation, Anxiety, Presyncope, Vaccination, Syncope Prevention

Eligibility Criteria

10 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Centers for Disease Control and Prevention
Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Buzzy ® and Electronic Game

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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

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.

Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, at (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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04772755

First Posted

February 24, 2021

Last Updated

July 25, 2023

Sponsor

Duke University

Collaborators

Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT04772755

Brief Title

Presyncope (Syncope) Prevention Study

Acronym

PS^2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

March 10, 2021 (Actual)

Primary Completion Date

June 15, 2022 (Actual)

Study Completion Date

June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Syncope, Vasovagal

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

338 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

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

Arm Title

Buzzy ® and Electronic Game

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Buzzy® and Electronic Game

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Day 1, 20 minutes post vaccination

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Day 1, ≤ 1 minute after vaccination

Title

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

Description

Time Frame

Day 1, ≤ 1 minute following vaccination

Title

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

Description

Time Frame

Day 1, ≤ 1 minute following vaccination

Title

Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at (Approximately) 10 Minutes Following Vaccination.

Description

Time Frame

Day 1, (approximately) 10 minutes following vaccination

Title

Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.

Description

Time Frame

Day 1, (approximately) 10 minutes following vaccination

Title

Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.

Description

Time Frame

Day 1, (approximately) 10 minutes following vaccination

Title

Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike

Description

The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.

Time Frame

Day 1, approximately 20 minutes post vaccination

Title

Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy

Description

The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.

Time Frame

Day 1, approximately 20 minutes post vaccination

Title

Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable

Description

The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.

Time Frame

Day 1, approximately 20 minutes post vaccination

Title

Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no

Description

The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.

Time Frame

Day 1, approximately 20 minutes post vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emmanual B Walter, MD, MPH

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Theresa Harrington, MD

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Karen R Broder, MD

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centers for Disease Control and Prevention

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30333

Country

United States

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Presyncope (Syncope) Prevention Study

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