Skip to content

Buzzy® Application in Pain

The Effect of Buzzy® Application on the Pain Level During Vaccine Injection in Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04990648
Enrollment
60
Registered
2021-08-04
Start date
2018-11-15
Completion date
2019-05-15
Last updated
2021-08-04

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

Conditions

Healthy

Keywords

Pain, Vaccination, Baby, Buzzy, Pediatric nurse

Brief summary

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.

Detailed 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.

Interventions

DEVICEBuzzy

Buzzy ® device (Buzzy ® Mini Healthcare) has been used to reduce pain by using local cold application and vibration effect. Buzzy ® was developed by Dr. Amy Baxter in 2009. The size of the Buzzy ® device measures 2⅞ꞌꞌ x 1⅞ꞌꞌ x ⅞ꞌꞌ (7,2 cm x 4,8 cm x 2,2 cm). It is a bee-shaped device made of hard plastic with a vibrating motor (2 settings - fixed and pulsed), powered by a 2AAA battery. There are 4 ice packages and elastic fastening strap. On the part where the device touches the skin, there is an ice package in the shape of a wing. When the button on the device is pressed, it vibrates.

Sponsors

Okan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 12 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The effect of Buzzy® administered during vaccine injection on the infant's SpO2 after vaccine injection.30 secondsSpO2
The effect of Buzzy® administered during vaccine injection on the infant's pain level before vaccine injection.30 secondsFLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
The effect of Buzzy® administered during vaccine injection on the infant's pain level during vaccine injection.30 secondsFLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
The effect of Buzzy® administered during vaccine injection on the infant's pain level after vaccine injection.30 secondsFLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
The effect of Buzzy® administered during vaccine injection on the infant's pulse before vaccine injection.30 secondspulse rate
The effect of Buzzy® administered during vaccine injection on the infant's pulse after vaccine injection.30 secondspulse rate
The effect of Buzzy® administered during vaccine injection on infant blood pressure before vaccine injection.30 secondsblood pressure
The effect of Buzzy® administered during vaccine injection on infant blood pressure after vaccine injection.30 secondsblood pressure
The effect of Buzzy® administered during vaccine injection on the infant's SpO2 before vaccine injection.30 secondsSpO2

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026