Distraction and Vibration for Minimizing Pain During Childhood Vaccination

Study Overview
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Brief Summary
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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.

Official Title
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Distraction and Vibration for Minimizing Pain During Childhood Vaccination

Conditions
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Pain Due to Childhood Vaccination

Intervention / Treatment
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* Device: Buzzy specific vibration device
* Behavioral: Distraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 1 year and 3 years, 11 months and 29 days of life. Be accompanied by legal guardian. Apply only one injectable vaccine at the time of the research. Exclusion Criteria: Refuses to sign the consent form. Have already been included in the study previously.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video distraction<br>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<br>* The distraction will be obtained through tablet with videos<br>|
| Experimental: Vibration device<br>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<br>* It is a device that produces vibration<br>|
| Experimental: Distraction plus vibration<br>Combination of the two interventions described above | Device: Buzzy specific vibration device<br>* It is a device that produces vibration<br>Behavioral: Distraction<br>* The distraction will be obtained through tablet with videos<br>|
| No Intervention: Usual care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of crying in seconds | The duration of crying will be used as surrogate endpoint to assess pain | Through study completion, an average 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The satisfaction of parents | The satisfaction of parents will be evaluated through a questionnaire | Through study completion, an average 6 months |