Buzzy® Application in Pain

Okan University

Status: Completed

Conditions: Healthy

Treatments: Device: Buzzy

Study type: Interventional

Funder types: Other

Identifiers

NCT04990648

2018-17-02

Details and patient eligibility

About

The research was conducted as a randomized controlled experiment to investigate the effect of Buzzy® on pain level during the measles-rubella-mumps (MMR) vaccine injection in 12-month-old infants. This study was done with infants meeting the sampling criteria (buzzy group: 30, control group: 30) on November 2018-May 2019 in Istanbul Bakirkoy 9 Family Health Center.

Full description

To determine the effect of Buzzy® application on pain, which is a combination of cold and vibration, during measles-rubella-mumps (MMR) vaccine injection administration on 12-month-old infants. The study is a randomized contrlled experimental research. The research sample is composed of 60 infants (buzzy:30, control:30) who are 12-month-old injected MMR vaccine at Bakırköy No. 9 Family Health Center between November 2018-May 2019. As a data collection tool Data Collection Form, FLACC Pain Scale and Buzzy® device have been used. While Buzzy® was applied on infants in the trial group before, during and after the vaccine injection, the infants in the control group were applied routine vaccine injection. The pain response of the infants was evaluated by the nurse and the parent before, during and after the vaccine injection and the physiological parameters were evaluated by the nurse before and after the vaccine injection.

Enrollment: 60 patients

Sex: All

Ages: 12 to 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The baby has completed 12 months,
• MMR vaccine will be applied,
• Being at a suitable weight for the month,
• The baby has not been given analgesic medication during the day,
• It can be listed as the parent's willingness to participate in the research.

Exclusion criteria

• It can be listed as having a body temperature above 37.5.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Buzzy group

Experimental group

Description:

Buzzy ® was placed on the left arm deltoid muscle site and kept there for 30 seconds. After 30 seconds, Buzzy ® was taken 1 cm up and MMR vaccine injection was administered to the left deltoid muscle site. After the vaccine injection, Buzzy ® was taken to the injection site and kept for another 30 seconds.

Treatment:

Device: Buzzy

Control group

No Intervention group

Description:

MMR vaccine injection was administered to the left deltoid muscle without any intervention or application to the injection site.