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.

Study Overview

• Status: Completed
• Conditions: Pain Due to Childhood Vaccination
• Intervention / Treatment: Behavioral: Distraction; Device: Buzzy specific vibration device

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Video distraction; A video will be available as soon as the child is randomized to this group, thus enabling the child to become more involved with distraction. A tablet will be delivered to the parents in the reception room to be viewed by the child before entering the vaccine room. After entering the room, the parents will keep the child entertained with the videos. There will be several videos, and it may be optional for the parents to choose according to their preferences.	Behavioral: Distraction; The distraction will be obtained through tablet with videos
Experimental: Vibration device; Buzzy® specific vibration device will be placed by the professional or caregiver at the application site, 15 to 45 seconds before the procedure.	Device: Buzzy specific vibration device; It is a device that produces vibration
Experimental: Distraction plus vibration; Combination of the two interventions described above	Behavioral: Distraction; The distraction will be obtained through tablet with videos; Device: Buzzy specific vibration device; It is a device that produces vibration
No Intervention: Usual care; The vaccine will be carried out according to the routine of the Vaccine Center. Lidocaine plus prilocaine, non-nutritive sucking or breastfeeding may be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The satisfaction of parents	The satisfaction of parents will be evaluated through a questionnaire	Through study completion, an average 6 months

Collaborators and Investigators

• Sponsor: Hospital Nossa Senhora da Conceicao

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Actual): October 30, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 30, 2018

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PCV-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No