Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study

Duke University30 enrolled

Overview

This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to being used in a larger study to assess the effectiveness of the interventions in preventing post-vaccination presyncope and syncope. Feasibility will be assessed according to study staff ability to successfully administer the protocol specified clinic-based interventions and per both study staff and healthcare provider responses to written feasibility assessments. Acceptability will be assessed according to the participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed per participant written self-report to standardized survey questions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Syncope, Vasovagal

Interventions

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 10 years through 17 years of age 2. If 10 through 13 years of age, the subject must be receiving at least one vaccine delivered intramuscularly 3. If 14 through 17 years of age, the subject must be receiving at least two injectable vaccines one of which must be delivered intramuscularly 4. 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. 5. The subject must be willing to stay for the completion of all study-related activities. 6. Parent/guardian and adolescent must speak and read English by self-report 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. Inability to hear 10. Significant visual impairment or blindness 11. Febrile or acutely ill individuals 12. Upper arm or shoulder pain or injury 13. Adolescent or parent/Guardian is an immediate relative of study staff or an employee who is supervised by study staff. 14. 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

Outcomes

Primary Outcomes

Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination

Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.

Time frame: Day1

Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure

Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.

Time frame: Day1

Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination

Music will be played over speakers for a minimum of 3 minutes prior to vaccination

Time frame: Day1

Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination

Music will be played over speakers through the 10 minute post vaccination pain assessment

Time frame: Day1

Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment

Subjects will be asked to complete an anxiety assessment prior to vaccination

Time frame: Day1

Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment

Subjects will be asked to complete a needle phobia assessment pre-vaccination

Time frame: Day1

Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.

Subjects will complete a post vaccination pain assessment within one minute of their final vaccination

Time frame: Day1

Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes

Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination

Time frame: Day1

Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment

Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s

Time frame: Day1

Number of Subjects Who Complete the Post Vaccination Anxiety Assessment

Subjects will complete a post vaccination anxiety assessment

Time frame: Day1

Number of Subjects Who Complete the Acceptability Assessment

Subjects will be given a questionnaire about the acceptability of their intervention.

Time frame: Day1

Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy

Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject

Time frame: Day1

Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive

Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject

Time frame: Day1

Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy

Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject

Time frame: Day1

Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive

Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject

Time frame: Day1

Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy

Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject

Time frame: Day1

Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive

Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject

Time frame: Day1

Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy

Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject

Time frame: Day1

Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive

Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject

Time frame: Day1

Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much