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OpenTrials
Completed

NCT Number: NCT03540589

Distraction and Vibration for Minimizing Pain During Childhood Vaccination

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.

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Key information

Conditions

Pain Due to Childhood Vaccination

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Buzzy specific vibration device

Device

It is a device that produces vibration

Distraction

Behavioral

The distraction will be obtained through tablet with videos

Primary outcomes

  1. 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

  1. The satisfaction of parents

    Time frame: Through study completion, an average 6 months

    The satisfaction of parents will be evaluated through a questionnaire

Sponsors and collaborators

Lead sponsor

Hospital Nossa Senhora da Conceicao

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 30, 2018
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.