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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Participants received usual care that followed administration of a vaccine and a 20 minute post vaccination observation period. | |
| Buzzy ® and Electronic Game | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buzzy® and Electronic Game | Device | Buzzy® was applied according to manufacturers directions and an electronic game was played. The participant was observed for 20 minutes post vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1, 20 minutes post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanual B Walter, MD, MPH | Duke University | Principal Investigator |
| Theresa Harrington, MD | Centers for Disease Control and Prevention | Principal Investigator |
| Karen R Broder, MD | Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centers for Disease Control and Prevention | Atlanta | Georgia | 30333 | United States | ||
| Duke University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41692229 | Derived | Smith MJ, Harrington TA, Chung RJ, Rountree W, Poniewierski MS, Spreng RL, Broder KR, Kroger A, McNeil MM, Marquez P, Walter EB. Preventing Postvaccination Presyncope and Syncope in Adolescents: A Randomized Controlled Trial of a Clinic-Based Intervention. J Pediatr. 2026 Jun;293:115035. doi: 10.1016/j.jpeds.2026.115035. Epub 2026 Feb 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Participants received usual care that follows administration of a vaccine and a 20 minute post vaccination observation period. |
| BG001 | Buzzy ® and Electronic Game |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine. | Posted | Count of Participants | Participants | Day 1, 20 minutes post vaccination |
|
During the 20-minute post-vaccination monitoring period
Only Serious Adverse Events were collected during the 20-minute post-vaccination monitoring period; Other (Not Including Serious) Adverse Events were not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants received usual care that followed administration of a vaccine and a 20 minute post vaccination observation period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emmanuel B Walter, MD, MPH | Duke University | 919-620-5346 | chip.walter@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2021 | Apr 26, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2021 | Apr 26, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2022 | Jun 30, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| D013575 | Syncope |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 1, approximately 20 minutes post vaccination |
| Durham |
| North Carolina |
| 27705 |
| United States |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| 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. |
|
|
|
| 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. | Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine. | Posted | Count of Participants | Participants | Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes) |
|
|
|
|
| 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. | Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine. | Posted | Mean | Full Range | scores on a scale | Day1: Pre-vaccination (baseline), Post-vaccination (20 minutes) |
|
|
|
|
| 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. | Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine. | Posted | Mean | Full Range | scores on a scale | Day 1, ≤ 1 minute after vaccination |
|
|
|
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| 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. | Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine. | Posted | Count of Participants | Participants | Day 1, ≤ 1 minute following vaccination |
|
|
|
|
| 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. | Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine. | Posted | Count of Participants | Participants | Day 1, ≤ 1 minute following vaccination |
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|
|
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| 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. | Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine. | Posted | Mean | Full Range | scores on a scale | Day 1, (approximately) 10 minutes following vaccination |
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|
|
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| 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. | Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine. | Posted | Count of Participants | Participants | Day 1, (approximately) 10 minutes following vaccination |
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|
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| 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. | Modified Intent-to-treat (mITT) analysis population is defined as those subjects who are enrolled, randomized into the study, and received an intramuscular vaccine. | Posted | Count of Participants | Participants | Day 1, (approximately) 10 minutes following vaccination |
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| 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. | Does not apply to the Usual Care arm. | Posted | Count of Participants | Participants | Day 1, approximately 20 minutes post vaccination |
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|
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| 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. | Does not apply to the Usual Care arm. | Posted | Count of Participants | Participants | Day 1, approximately 20 minutes post vaccination |
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| 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. | Does not apply to the Usual Care arm. | Posted | Count of Participants | Participants | Day 1, approximately 20 minutes post vaccination |
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| 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. | Does not apply to the Usual Care arm. | Posted | Count of Participants | Participants | Day 1, approximately 20 minutes post vaccination |
|
|
|
| 0 |
| 167 |
| 0 |
| 167 |
| 0 |
| 0 |
| EG001 | 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. 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. | 0 | 165 | 0 | 165 | 0 | 0 |
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| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| No Change |
|
| Liked a little |
|
| Liked very much |
|
| Not sure |
|
| How much do you like playing a game during the shot(s)? |
|
| Somewhat easy |
|
| Very easy |
|
| Not sure |
|
| How difficult or easy was it to select and play the game? |
|
| Somewhat comfortable |
|
| Very comfortable |
|
| Not sure |
|
| How comfortable or uncomfortable were you playing a game when receiving shots? |
|
| Did the vibration of Buzzy bother you? |
|
| If you had the choice, would you like to use Buzzy again when receiving shot(s)? |
|
| If you had the choice, would you like to play a game again when receiving shot(s)? |
|