Distraction and Vibration for Minimizing Pain During Childhood Vaccination

Hospital Nossa Senhora da Conceicao

Status: Completed

Conditions: Pain Due to Childhood Vaccination

Treatments: Device: Buzzy specific vibration device; Behavioral: Distraction

Study type: Interventional

Funder types: Other

Identifiers

NCT03540589

PCV-001

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 1 to 3 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

204 participants in 4 patient groups

Video distraction

Experimental group

Description:

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.

Treatment:

Behavioral: Distraction

Vibration device

Experimental group

Description:

Buzzy® specific vibration device will be placed by the professional or caregiver at the application site, 15 to 45 seconds before the procedure.

Treatment:

Device: Buzzy specific vibration device

Distraction plus vibration

Experimental group

Description:

Combination of the two interventions described above

Treatment:

Behavioral: Distraction

Device: Buzzy specific vibration device

Usual care

No Intervention group

Description:

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.