Distraction and Vibration for Minimizing Pain During Childhood Vaccination
1 other identifier
interventional
204
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2018
CompletedStudy Start
First participant enrolled
May 21, 2018
CompletedFirst Posted
Study publicly available on registry
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedFebruary 22, 2019
February 1, 2019
5 months
April 23, 2018
February 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
The satisfaction of parents
Through study completion, an average 6 months
Study Arms (4)
Video distraction
EXPERIMENTALA 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.
Vibration device
EXPERIMENTALBuzzy® specific vibration device will be placed by the professional or caregiver at the application site, 15 to 45 seconds before the procedure.
Distraction plus vibration
EXPERIMENTALCombination of the two interventions described above
Usual care
NO INTERVENTIONThe vaccine will be carried out according to the routine of the Vaccine Center. Lidocaine plus prilocaine, non-nutritive sucking or breastfeeding may be used.
Interventions
It is a device that produces vibration
The distraction will be obtained through tablet with videos
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Refuses to sign the consent form.
- Have already been included in the study previously.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 23, 2018
First Posted
May 30, 2018
Study Start
May 21, 2018
Primary Completion
October 30, 2018
Study Completion
October 30, 2018
Last Updated
February 22, 2019
Record last verified: 2019-02