Distraction and Vibration for Minimizing Pain During Childhood Vaccination

Pain Due to Childhood Vaccination Clinical Trial

Official title:

Distraction and Vibration for Minimizing Pain During Childhood Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540589
• Other study ID #: PCV-001
• Status: Completed
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: February 2019
• Source: Hospital Nossa Senhora da Conceicao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Due to Childhood Vaccination

Intervention

Device:
• Buzzy specific vibration device
It is a device that produces vibration

Behavioral:
• Distraction
The distraction will be obtained through tablet with videos

Locations

Country	Name	City	State
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nossa Senhora da Conceicao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	The satisfaction of parents	The satisfaction of parents will be evaluated through a questionnaire	Through study completion, an average 6 months