Distraction and Vibration for Minimizing Pain During Childhood Vaccination
NCT ID: NCT03540589
Last Updated: 2019-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
204 participants
INTERVENTIONAL
2018-05-21
2018-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Video distraction
A video will be available as soon as the child is randomized to this group, thus enabling the child to become more involved with distraction. A tablet will be delivered to the parents in the reception room to be viewed by the child before entering the vaccine room. After entering the room, the parents will keep the child entertained with the videos. There will be several videos, and it may be optional for the parents to choose according to their preferences.
Distraction
The distraction will be obtained through tablet with videos
Vibration device
Buzzy® specific vibration device will be placed by the professional or caregiver at the application site, 15 to 45 seconds before the procedure.
Buzzy specific vibration device
It is a device that produces vibration
Distraction plus vibration
Combination of the two interventions described above
Buzzy specific vibration device
It is a device that produces vibration
Distraction
The distraction will be obtained through tablet with videos
Usual care
The vaccine will be carried out according to the routine of the Vaccine Center. Lidocaine plus prilocaine, non-nutritive sucking or breastfeeding may be used.
No interventions assigned to this group
Interventions
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Buzzy specific vibration device
It is a device that produces vibration
Distraction
The distraction will be obtained through tablet with videos
Eligibility Criteria
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Inclusion Criteria
* Be accompanied by legal guardian.
* Apply only one injectable vaccine at the time of the research.
Exclusion Criteria
* Have already been included in the study previously.
1 Year
3 Years
ALL
Yes
Sponsors
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Hospital Nossa Senhora da Conceicao
OTHER
Responsible Party
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Marcio Manozzo Boniatti
Professor
Locations
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Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Other Identifiers
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PCV-001
Identifier Type: -
Identifier Source: org_study_id
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