Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video distraction | Experimental | 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. |
|
| Vibration device | Experimental | Buzzy® specific vibration device will be placed by the professional or caregiver at the application site, 15 to 45 seconds before the procedure. |
|
| Distraction plus vibration | Experimental | Combination of the two interventions described above |
|
| Usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buzzy specific vibration device | Device | It is a device that produces vibration |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | Brazil |
Not provided
| ID | Term |
|---|---|
| D019857 | Osteogenesis, Distraction |
| ID | Term |
|---|---|
| D001852 | Bone Lengthening |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Distraction | Behavioral | The distraction will be obtained through tablet with videos |
|