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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
338
Buzzy® was applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
Centers for Disease Control and Prevention
Atlanta, Georgia, United States
Duke University
Durham, North Carolina, United States
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.
Time frame: Day 1, 20 minutes post vaccination
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.
Time frame: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
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
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
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
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
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
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
Time frame: Day 1, approximately 20 minutes post vaccination
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