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Distraction and Vibration for Minimizing Pain During Childhood Vaccination

Not Applicable
Completed
Conditions
Pain Due to Childhood Vaccination
Registration Number
NCT03540589
Lead Sponsor
Hospital Nossa Senhora da Conceicao
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
204
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Duration of crying in secondsThrough study completion, an average 6 months

The duration of crying will be used as surrogate endpoint to assess pain

Secondary Outcome Measures
NameTimeMethod
The satisfaction of parentsThrough study completion, an average 6 months

The satisfaction of parents will be evaluated through a questionnaire

Trial Locations

Locations (1)

Hospital Moinhos de Vento

🇧🇷

Porto Alegre, Rio Grande Do Sul, Brazil

Hospital Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil

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