Presyncope (Syncope) Prevention Study

NCT ID: NCT04772755

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2022-06-15

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.

Conditions

Syncope, Vasovagal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Buzzy® and Electronic Game

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanual B Walter, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Theresa Harrington, MD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Karen R Broder, MD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

Centers for Disease Control and Prevention

Atlanta, Georgia, United States

Duke University

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00107635

Identifier Type: -

Identifier Source: org_study_id