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Buzzy® and Distraction®: relief of pain in childhood vaccination

Use of Buzzy® and Distraction® devices for patient reflief during child vaccination

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5npk9s
Enrollment
Unknown
Registered
2018-12-13
Start date
2018-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain relief during immunization of children.

Interventions

A group of 120 children was randomized to three groups: experimental group 1 (GE1), experimental group 2 (GE2) and control group (CG). Each group consisted of 40 children. For the GE1 group, the Buzzy
Device
E03.091

Sponsors

Universidade Federal de Sergipe
Lead Sponsor
Universidade Federal de Sergipe
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion among children aged two to four years who attended the UBS for vaccination, accompanied by at least one of their legal guardians, were considered eligible for inclusion for injectable immunization recommended by the PNI vaccination schedule for their respective age group.

Exclusion criteria

Exclusion criteria: Participants who took any analgesic in the last six hours were excluded from the sample; have some type of injury or abrasions in the region where the device will be placed; have a history of syncope during procedures involving needle; have a fever; vomiting; lowering of consciousness level; or have some type of deficiency or underlying neurological disease.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Buzzy and Distraction devices will reduce pain levels, as measured by the Wong-Baker Pain Scale.;Expected outcome 2: Buzzy and Distraction devices will reduce anxiety levels, as measured by the Infant Fear Scale.

Secondary

MeasureTime frame
Secondary outcomes aren't expected.

Countries

Brazil

Contacts

Public ContactViviane Fontes

Universidade Federal de Sergipe

vivianefontes00@hotmail.com+55-075-998215633

Outcome results

None listed

Source: REBEC (via WHO ICTRP)