An interventional study of Buzzy specific vibration device and Distraction in Pain Due to Childhood Vaccination, sponsored by Hospital Nossa Senhora da Conceicao. Completed at 1 site in Brazil. Open to participants aged 1 Year to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-22.
Sponsored by Hospital Nossa Senhora da Conceicao · Not applicable, Interventional, and Prevention
Vaccine pain control is one of the actions suggested to support the delivery of vaccines that are on a vaccine schedule, since pain and anxiety associated with vaccines are among the main reasons why children and their parents fail to do them properly. Thus, it is very important to investigate which interventions can bring greater benefit in the control of pain.This is a randomized clinical trial aiming to assess the impact of video distraction and vibration device on pain during the vaccination of children between one and three years.
Hospital Nossa Senhora da Conceicao is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Distraction
Buzzy® specific vibration device will be placed by the professional or caregiver at the application site, 15 to 45 seconds before the procedure.
Device: Buzzy specific vibration device
Combination of the two interventions described above
Device: Buzzy specific vibration device · Behavioral: Distraction
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.
It is a device that produces vibration
The distraction will be obtained through tablet with videos
Duration of crying in seconds
The duration of crying will be used as surrogate endpoint to assess pain
Time frame: Through study completion, an average 6 months
The satisfaction of parents
The satisfaction of parents will be evaluated through a questionnaire
Time frame: Through study completion, an average 6 months
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Hospital Nossa Senhora da Conceicao