Trial Outcomes & Findings for Presyncope (Syncope) Prevention Study (NCT NCT04772755)
NCT ID: NCT04772755
Last Updated: 2023-08-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
338 participants
Primary outcome timeframe
Day 1, 20 minutes post vaccination
Results posted on
2023-08-16
Participant Flow
Participant milestones
| Measure |
Usual Care
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
168
|
|
Overall Study
COMPLETED
|
167
|
165
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Usual Care
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Randomized and subsequently determined to be ineligible
|
2
|
3
|
Baseline Characteristics
Presyncope (Syncope) Prevention Study
Baseline characteristics by cohort
| Measure |
Usual Care
n=167 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=165 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.9 years
n=5 Participants
|
11.8 years
n=7 Participants
|
11.85 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
60 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
92 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
167 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, 20 minutes post vaccinationPopulation: Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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.
Outcome measures
| Measure |
Usual Care
n=167 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=165 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups.
|
80 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)Population: Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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.
Outcome measures
| Measure |
Usual Care
n=163 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=164 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.
Increase
|
28 Participants
|
28 Participants
|
|
Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.
Decrease
|
121 Participants
|
123 Participants
|
|
Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety.
No Change
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes)Population: Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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.
Outcome measures
| Measure |
Usual Care
n=167 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=165 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety.
|
5.69 scores on a scale
Interval -13.0 to 37.0
|
5.23 scores on a scale
Interval -11.0 to 37.0
|
SECONDARY outcome
Timeframe: Day 1, ≤ 1 minute after vaccinationPopulation: Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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.
Outcome measures
| Measure |
Usual Care
n=167 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=165 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at ≤ 1 Minute Following Vaccination.
|
3.26 scores on a scale
Interval 0.0 to 10.0
|
2.51 scores on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 1, ≤ 1 minute following vaccinationPopulation: Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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.
Outcome measures
| Measure |
Usual Care
n=167 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=165 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.
|
136 Participants
|
124 Participants
|
SECONDARY outcome
Timeframe: Day 1, ≤ 1 minute following vaccinationPopulation: Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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.
Outcome measures
| Measure |
Usual Care
n=167 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=165 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination.
|
77 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Day 1, (approximately) 10 minutes following vaccinationPopulation: Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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.
Outcome measures
| Measure |
Usual Care
n=167 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=165 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at (Approximately) 10 Minutes Following Vaccination.
|
1.54 scores on a scale
Interval 0.0 to 10.0
|
1.09 scores on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 1, (approximately) 10 minutes following vaccinationPopulation: Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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.
Outcome measures
| Measure |
Usual Care
n=167 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=165 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.
|
84 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Day 1, (approximately) 10 minutes following vaccinationPopulation: Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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.
Outcome measures
| Measure |
Usual Care
n=167 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
Buzzy ® and Electronic Game
n=165 Participants
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination.
|
30 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 1, approximately 20 minutes post vaccinationPopulation: Does not apply to the Usual Care arm.
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
Outcome measures
| Measure |
Usual Care
n=165 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like having Buzzy on your arm(s) during the shot(s)? · Disliked very much
|
4 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like having Buzzy on your arm(s) during the shot(s)? · Disliked a little
|
16 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like having Buzzy on your arm(s) during the shot(s)? · Neither liked nor disliked
|
28 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like having Buzzy on your arm(s) during the shot(s)? · Liked a little
|
35 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like having Buzzy on your arm(s) during the shot(s)? · Liked very much
|
76 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like having Buzzy on your arm(s) during the shot(s)? · Not sure
|
6 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like playing a game during the shot(s)? · Disliked very much
|
1 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like playing a game during the shot(s)? · Disliked a little
|
0 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like playing a game during the shot(s)? · Neither liked nor disliked
|
19 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like playing a game during the shot(s)? · Liked a little
|
22 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like playing a game during the shot(s)? · Liked very much
|
122 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike
How much do you like playing a game during the shot(s)? · Not sure
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1, approximately 20 minutes post vaccinationPopulation: Does not apply to the Usual Care arm.
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
Outcome measures
| Measure |
Usual Care
n=165 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was holding or having Buzzy held on your arm(s) during the shot(s)? · Very difficult
|
1 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was holding or having Buzzy held on your arm(s) during the shot(s)? · Somewhat difficult
|
8 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was holding or having Buzzy held on your arm(s) during the shot(s)? · Neither difficult nor easy
|
15 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was holding or having Buzzy held on your arm(s) during the shot(s)? · Somewhat easy
|
23 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was holding or having Buzzy held on your arm(s) during the shot(s)? · Very easy
|
111 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was holding or having Buzzy held on your arm(s) during the shot(s)? · Not sure
|
7 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was it to select and play the game? · Very difficult
|
2 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was it to select and play the game? · Somewhat difficult
|
3 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was it to select and play the game? · Neither difficult nor easy
|
7 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was it to select and play the game? · Somewhat easy
|
21 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was it to select and play the game? · Very easy
|
129 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Difficult or Easy
How difficult or easy was it to select and play the game? · Not sure
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1, approximately 20 minutes post vaccinationPopulation: Does not apply to the Usual Care arm.
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
Outcome measures
| Measure |
Usual Care
n=165 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable was Buzzy on your arm(s) during the shot(s)? · Very uncomfortable
|
11 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable was Buzzy on your arm(s) during the shot(s)? · Somewhat uncomfortable
|
34 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable was Buzzy on your arm(s) during the shot(s)? · Neither comfortable nor uncomfortable
|
16 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable was Buzzy on your arm(s) during the shot(s)? · Somewhat comfortable
|
47 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable was Buzzy on your arm(s) during the shot(s)? · Very comfortable
|
53 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable was Buzzy on your arm(s) during the shot(s)? · Not sure
|
4 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable were you playing a game when receiving shots? · Very uncomfortable
|
4 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable were you playing a game when receiving shots? · Somewhat uncomfortable
|
5 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable were you playing a game when receiving shots? · Neither comfortable nor uncomfortable
|
12 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable were you playing a game when receiving shots? · Somewhat comfortable
|
37 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable were you playing a game when receiving shots? · Very comfortable
|
100 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable
How comfortable or uncomfortable were you playing a game when receiving shots? · Not sure
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1, approximately 20 minutes post vaccinationPopulation: Does not apply to the Usual Care arm.
The Buzzy and electronic game acceptability survey consists of 11 items with varying responses.
Outcome measures
| Measure |
Usual Care
n=165 Participants
Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period.
|
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 play that game for a specified amount of time before, during and after the vaccination administration.
Buzzy® and Electronic Game: Buzzy® were applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination.
|
|---|---|---|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
If you had the choice, would you like to use Buzzy again when receiving shot(s)? · Yes
|
131 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
Did the cold temperature of Buzzy bother you? · No
|
113 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
Did the cold temperature of Buzzy bother you? · Yes
|
35 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
Did the cold temperature of Buzzy bother you? · Not sure
|
17 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
Did the vibration of Buzzy bother you? · No
|
147 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
Did the vibration of Buzzy bother you? · Yes
|
10 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
Did the vibration of Buzzy bother you? · Not sure
|
8 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
If you had the choice, would you like to use Buzzy again when receiving shot(s)? · No
|
19 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
If you had the choice, would you like to use Buzzy again when receiving shot(s)? · Not sure
|
15 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
If you had the choice, would you like to play a game again when receiving shot(s)? · No
|
18 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
If you had the choice, would you like to play a game again when receiving shot(s)? · Yes
|
134 Participants
|
—
|
|
Number of Adolescents Reporting Perceptions About Their Vaccination Experience Via an Acceptability Survey - Yes or no
If you had the choice, would you like to play a game again when receiving shot(s)? · Not sure
|
13 Participants
|
—
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Buzzy ® and Electronic Game
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place