Syncope, Vasovagal
Conditions
Keywords
Adolescent, Child, Buzzy®, Electronic Game, Syncope, Pain Mitigation, Anxiety, Presyncope, Vaccination, Syncope Prevention
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.
Interventions
DEVICEBuzzy® 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.
Sponsors
Centers for Disease Control and Prevention
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups. | Day 1, 20 minutes post vaccination | 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
| Measure | Time frame | Description |
|---|---|---|
| Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety. | Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes) | 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. | Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes) | 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. | Day 1, ≤ 1 minute after 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. | Day 1, ≤ 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 ≥ 4, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination. | Day 1, ≤ 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 Perceptions About Their Vaccination Experience Via an Acceptability Survey - Comfortable or Uncomfortable | Day 1, approximately 20 minutes post vaccination | The Buzzy and electronic game acceptability survey consists of 11 items with varying responses. |
| Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination. | Day 1, (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 ≥ 4, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination. | Day 1, (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 Perceptions About Their Vaccination Experience Via an Acceptability Survey - Like or Dislike | Day 1, approximately 20 minutes post vaccination | 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 | Day 1, approximately 20 minutes post vaccination | 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 | Day 1, approximately 20 minutes post vaccination | The Buzzy and electronic game acceptability survey consists of 11 items with varying responses. |
| Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at (Approximately) 10 Minutes Following Vaccination. | Day 1, (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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period. | 167 |
| 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. | 165 |
| Total | 332 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Randomized and subsequently determined to be ineligible | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Care | Total | Buzzy ® and Electronic Game |
|---|---|---|---|
| Age, Continuous | 11.9 years | 11.85 years | 11.8 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 26 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 156 Participants | 306 Participants | 150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 14 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants | 112 Participants | 52 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 20 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 92 Participants | 179 Participants | 87 Participants |
| Region of Enrollment United States | 167 Participants | 332 Participants | 165 Participants |
| Sex: Female, Male Female | 86 Participants | 173 Participants | 87 Participants |
| Sex: Female, Male Male | 81 Participants | 159 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 0 / 165 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 167 | 0 / 165 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups. | 80 Participants |
| Buzzy ® and Electronic Game | Number of Adolescents With Presyncope or Syncope After Vaccination in the Intervention and Usual Care Groups. | 59 Participants |
p-value: 0.0249Chi-squared
Secondary
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)
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual Care | Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety. | Increase | 28 Participants |
| Usual Care | Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety. | Decrease | 121 Participants |
| Usual Care | Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety. | No Change | 14 Participants |
| Buzzy ® and Electronic Game | Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety. | No Change | 13 Participants |
| Buzzy ® and Electronic Game | Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety. | Increase | 28 Participants |
| Buzzy ® and Electronic Game | Categorical Change (Increase, Decrease, no Change) in Pre- and Post- Vaccination State Anxiety. | Decrease | 123 Participants |
p-value: 0.8918Mantel Haenszel
Secondary
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
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at ≤ 1 Minute Following Vaccination. | 3.26 scores on a scale |
| Buzzy ® and Electronic Game | Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at ≤ 1 Minute Following Vaccination. | 2.51 scores on a scale |
p-value: 0.0059Wilcoxon (Mann-Whitney)
Secondary
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
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at (Approximately) 10 Minutes Following Vaccination. | 1.54 scores on a scale |
| Buzzy ® and Electronic Game | Mean Injection-site Pain Scores on the Wong-Baker Faces Pain Scale© at (Approximately) 10 Minutes Following Vaccination. | 1.09 scores on a scale |
p-value: 0.0273Wilcoxon (Mann-Whitney)
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination. | 136 Participants |
| Buzzy ® and Electronic Game | Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination. | 124 Participants |
p-value: 0.1647Chi-squared
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | 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 |
| Buzzy ® and Electronic Game | Number of Adolescents Reporting an Injection Site Pain Score ≥ 2, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination. | 65 Participants |
p-value: 0.0458Chi-squared
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination. | 77 Participants |
| Buzzy ® and Electronic Game | Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, ≤ 1 Minute Following Vaccination. | 53 Participants |
p-value: 0.009Chi-squared
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | 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 |
| Buzzy ® and Electronic Game | Number of Adolescents Reporting an Injection Site Pain Score ≥ 4, on the Wong-Baker Faces Pain Scale©, at (Approximately) 10 Minutes Following Vaccination. | 19 Participants |
p-value: 0.0976Chi-squared
Secondary
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
Population: Does not apply to the Usual Care arm.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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
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
Population: Does not apply to the Usual Care arm.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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
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
Population: Does not apply to the Usual Care arm.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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
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
Population: Does not apply to the Usual Care arm.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
| Usual Care | 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 |
Secondary
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)
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual Care | Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety. | 5.69 scores on a scale |
| Buzzy ® and Electronic Game | Numeric Change (Mean and Range) in Pre- Minus Post- Vaccination State Anxiety. | 5.23 scores on a scale |
p-value: 0.6587Wilcoxon (Mann-Whitney)