Syncope, VasovagalNCT03533829
Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
A study testing Buzzy® and Music in people with Syncope, Vasovagal, run by Duke University at 2 sites in United States.
Trial summary
This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Syncope, Vasovagal
- What is being tested?
- Buzzy® and Music
- Type of treatment
- Vaccines, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Jun 2018to 19 Jul 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 10 years through 17 years of age
- If 10 through 13 years of age, the subject must be receiving at least one vaccine delivered intramuscularly
- If 14 through 17 years of age, the subject must be receiving at least two injectable vaccines one of which must be delivered intramuscularly
- 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.
- The subject must be willing to stay for the completion of all study-related activities.
- Parent/guardian and adolescent must speak and read English by self-report
Who cannot join
- Receipt of investigational or experimental vaccine or medication within the previous two weeks
- Receipt of routine injectable medication
- Permanent indwelling venous catheter
- Blood drawn within the past hour or scheduled for a blood draw during the post-vaccination observation period
- Injection of medication during the past hour or scheduled for injection of medication during the observation period.
- Cold intolerance or cold urticaria
Show all 14Show fewer
- Raynaud's phenomenon
- Sickle cell disease
- Inability to hear
- Significant visual impairment or blindness
- Febrile or acutely ill individuals
- Upper arm or shoulder pain or injury
- Adolescent or parent/Guardian is an immediate relative of study staff or an employee who is supervised by study staff.
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Centers for Disease Control and Prevention
Atlanta, Georgia, 30333
Duke University
Durham, North Carolina, 27705
About this study
This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to being used in a larger study to assess the effectiveness of the interventions in preventing post-vaccination presyncope and syncope. Feasibility will be assessed according to study staff ability to successfully administer the protocol specified clinic-based interventions and per both study staff and healthcare provider responses to written feasibility assessments. Acceptability will be assessed according to the participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed per participant written self-report to standardized survey questions.
- Conditions
- Syncope, Vasovagal
- Being tested
- Buzzy®, Music
- Keywords
- vaccination, pre-syncope, syncope prevention
- Medical subject headings
- Syncope, Vasovagal, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buzzy®Device
Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.
MusicBehavioural
Music will be selected and listened to as a distraction before and during vaccination.
| Study group | Role | What they receive |
|---|---|---|
| Buzzy® | Active comparator | Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination. Receives: Device: Buzzy® |
| Music | Active comparator | Music will be selected and listened to as a distraction before and during vaccination. Receives: Behavioral: Music |
| Buzzy® and Music | Active comparator | Buzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination. Receives: Device: Buzzy®; Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Measured: Day1
Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure
Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.
Measured: Day1
Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination
Music will be played over speakers for a minimum of 3 minutes prior to vaccination
Measured: Day1
Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination
Music will be played over speakers through the 10 minute post vaccination pain assessment
Measured: Day1
Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
Subjects will be asked to complete an anxiety assessment prior to vaccination
Measured: Day1
Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
Subjects will be asked to complete a needle phobia assessment pre-vaccination
Measured: Day1
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.
Subjects will complete a post vaccination pain assessment within one minute of their final vaccination
Measured: Day1
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes
Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination
Measured: Day1
Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment
Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s
Measured: Day1
Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
Subjects will complete a post vaccination anxiety assessment
Measured: Day1
Number of Subjects Who Complete the Acceptability Assessment
Subjects will be given a questionnaire about the acceptability of their intervention.
Measured: Day1
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Measured: Day1
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Measured: Day1
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Measured: Day1
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Measured: Day1
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Measured: Day1
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Measured: Day1
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Measured: Day1
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Measured: Day1
Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Measured: Day1
Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Measured: Day1
Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Measured: Day1
Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Measured: Day1
Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Measured: Day1
Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Measured: Day1
Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Measured: Day1
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Measured: Day1
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Measured: Day1
Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Measured: Day1
Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Measured: Day1
Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start4 Jun 2018
- Primary completion19 Jul 2018
- Study completion19 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Syncope, VasovagalStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Emmanuel "Chip" B Walter, MD, MPH, Principal investigator, Duke UniveristyTheresa Harrington, MD, MPH&TM, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533829
- Sponsor's protocol ID
- PRO00094074
- Other IDs
- 200 2012 53663 0013
- Status last verified
- Jul 2019
- First submitted
- 11 May 2018
- Last updated
- 16 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study
- ClinicalTrials.gov ID
- NCT03533829
- Acronym / sponsor ID
- PRO00094074
- Conditions
- Syncope, Vasovagal
- Keywords
- vaccination, pre-syncope, syncope prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 16 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to being used in a larger study to assess the effectiveness of the interventions in preventing post-vaccination presyncope and syncope. Feasibility will be assessed according to study staff ability to successfully administer the protocol specified clinic-based interventions and per both study staff and healthcare provider responses to written feasibility assessments. Acceptability will be assessed according to the participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed per participant written self-report to standardized survey questions.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buzzy® | Active comparator | Device: Buzzy®Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination. |
| Music | Active comparator | Behavioral: MusicMusic will be selected and listened to as a distraction before and during vaccination. |
| Buzzy® and Music | Active comparator | Device: Buzzy®, Behavioral: MusicBuzzy® will be applied to the arm prior to and during vaccination and music will be selected and listened to before and during vaccination. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 10 years through 17 years of age
- If 10 through 13 years of age, the subject must be receiving at least one vaccine delivered intramuscularly
- If 14 through 17 years of age, the subject must be receiving at least two injectable vaccines one of which must be delivered intramuscularly
- 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.
- The subject must be willing to stay for the completion of all study-related activities.
Key exclusion criteria (14 listed)
- Receipt of investigational or experimental vaccine or medication within the previous two weeks
- Receipt of routine injectable medication
- Permanent indwelling venous catheter
- Blood drawn within the past hour or scheduled for a blood draw during the post-vaccination observation period
- Injection of medication during the past hour or scheduled for injection of medication during the observation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buzzy®Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination. | Device | Buzzy®, Buzzy® and Music |
| MusicMusic will be selected and listened to as a distraction before and during vaccination. | Behavioural | Buzzy® and Music, Music |
Primary outcome
Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination
Time frame: Day1
Buzzy® will be applied to and kept on the subjects arm for a minimum of 30 seconds prior to vaccination.
Number of Subjects Who Have Buzzy® Kept on Vaccination Arm/s During the Entire Vaccination Procedure
Time frame: Day1
Buzzy® will be applied to and kept on the subjects arm for the duration of the vaccination procedure.
Number of Subjects Who Have Music Playing for ≥ 3 Minutes Prior to Vaccination
Time frame: Day1
Music will be played over speakers for a minimum of 3 minutes prior to vaccination
Number of Subjects Who Have Music Playing for 10 Minutes Post Vaccination
Time frame: Day1
Music will be played over speakers through the 10 minute post vaccination pain assessment
Number of Subjects Who Complete the Pre-vaccination Anxiety Assessment
Time frame: Day1
Subjects will be asked to complete an anxiety assessment prior to vaccination
Number of Subjects Who Complete the Pre-vaccination Needle Phobia Assessment
Time frame: Day1
Subjects will be asked to complete a needle phobia assessment pre-vaccination
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 1 Minute.
Time frame: Day1
Subjects will complete a post vaccination pain assessment within one minute of their final vaccination
Number of Subjects Who Complete the Post-vaccination Pain Assessment at 10 Minutes
Time frame: Day1
Subjects will complete a post vaccination pain assessment at 10 minutes after their final vaccination
Number of Subjects Who Complete the Post-vaccination Presyncope Symptom Assessment
Time frame: Day1
Subjects will complete a questionnaire about presyncope symptoms after their vaccination/s
Number of Subjects Who Complete the Post Vaccination Anxiety Assessment
Time frame: Day1
Subjects will complete a post vaccination anxiety assessment
Number of Subjects Who Complete the Acceptability Assessment
Time frame: Day1
Subjects will be given a questionnaire about the acceptability of their intervention.
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Time frame: Day1
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Number of Reports From Coordinators That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Time frame: Day1
Coordinators will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Time frame: Day1
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Number of Reports From Coordinators That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Time frame: Day1
Coordinators will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Easy or Very Easy
Time frame: Day1
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Number of Reports From Providers That Indicated Having Music Playing During the Vaccine Administration Was Somewhat Assistive or Very Assistive
Time frame: Day1
Providers will answer a questionnaire about the feasibility of the music intervention after each encounter with a subject
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Easy or Very Easy
Time frame: Day1
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Number of Reports From Providers That Indicated Having Buzzy® Applied in Conjunction With the Vaccination Was Somewhat Assistive or Very Assistive
Time frame: Day1
Providers will answer a questionnaire about the feasibility of the Buzzy® intervention after each encounter with a subject
Number of Subjects Who Like Having Music Play During Their Shot/s a Little or Very Much
Time frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Felt Having Music Play During Their Shot/s Was Somewhat Easy or Easy
Time frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Found Music Playing While Receiving Their Shots to be Somewhat Comfortable or Very Comfortable
Time frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Found the Music Playing While They Got Their Shot/s to be Just Right
Time frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Would be Somewhat Likely or Very Likely to Want to Listen to Music Again While Receiving Shot/s
Time frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Found the Music App Sufficient or Somewhat Sufficient to Selecting the Music They Like
Time frame: Day1
Subjects will complete a survey about the acceptability of the music intervention during their vaccinations
Number of Subjects Who Either Like a Little or Very Much Liked Having Buzzy® on Their Arm/s During Shot/s
Time frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Easy or Very Easy
Time frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Found Having Buzzy® on Their Arm/s During Shot/s Somewhat Comfortable or Very Comfortable
Time frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Were Not Bothered by the Cold Temperature of Buzzy® on Their Arm/s During Shot/s
Time frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Were Not Bothered by the Vibration of Buzzy® on Their Arm/s During Shot/s
Time frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Number of Subjects Who Would Choose to Have Buzzy® on Their Arm/s During Shot/s Again
Time frame: Day1
Subjects will complete a survey about the acceptability of the Buzzy® intervention during their vaccinations
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel "Chip" B Walter, MD, MPH principal investigator
Duke Univeristy
Theresa Harrington, MD, MPH&TM principal investigator
Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy® and Music in people with Syncope, Vasovagal, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Who Have Buzzy® Applied to and Kept at Vaccination Site/s for ≥ 30 Seconds Prior to Vaccination (time frame: Day1). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.