Pain Due to Childhood Vaccination
Conditions
Brief summary
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.
Interventions
DEVICEBuzzy specific vibration device
It is a device that produces vibration
BEHAVIORALDistraction
The distraction will be obtained through tablet with videos
Sponsors
Hospital Nossa Senhora da Conceicao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of crying in seconds | Through study completion, an average 6 months | The duration of crying will be used as surrogate endpoint to assess pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The satisfaction of parents | Through study completion, an average 6 months | The satisfaction of parents will be evaluated through a questionnaire |
Countries
Brazil
Outcome results
None listed