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Clinical Trials/NCT03540589
NCT03540589
Completed
N/A

Distraction and Vibration for Minimizing Pain During Childhood Vaccination

Hospital Nossa Senhora da Conceicao1 site in 1 country204 target enrollmentMay 21, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain Due to Childhood Vaccination
Sponsor
Hospital Nossa Senhora da Conceicao
Enrollment
204
Locations
1
Primary Endpoint
Duration of crying in seconds
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 21, 2018
End Date
October 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marcio Manozzo Boniatti

Professor

Hospital Nossa Senhora da Conceicao

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Duration of crying in seconds

Time Frame: Through study completion, an average 6 months

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

Secondary Outcomes

  • The satisfaction of parents(Through study completion, an average 6 months)

Study Sites (1)

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