Buzzy® Application in Pain

July 27, 2021 updated by: Ozge Siktas, Istanbul Okan Univesitesi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Istanbul
      • Tuzla, Istanbul, Turkey, 34959
        • Istanbul Okan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Buzzy group
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.
Device: Buzzy
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.
No Intervention: Control group
MMR vaccine injection was administered to the left deltoid muscle without any intervention or application to the injection site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of Buzzy® administered during vaccine injection on the infant's pain level before vaccine injection.
Time Frame: 30 seconds
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
30 seconds
The effect of Buzzy® administered during vaccine injection on the infant's pain level during vaccine injection.
Time Frame: 30 seconds
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
30 seconds
The effect of Buzzy® administered during vaccine injection on the infant's pain level after vaccine injection.
Time Frame: 30 seconds
FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).
30 seconds
The effect of Buzzy® administered during vaccine injection on the infant's pulse before vaccine injection.
Time Frame: 30 seconds
pulse rate
30 seconds
The effect of Buzzy® administered during vaccine injection on the infant's pulse after vaccine injection.
Time Frame: 30 seconds
pulse rate
30 seconds
The effect of Buzzy® administered during vaccine injection on infant blood pressure before vaccine injection.
Time Frame: 30 seconds
blood pressure
30 seconds
The effect of Buzzy® administered during vaccine injection on infant blood pressure after vaccine injection.
Time Frame: 30 seconds
blood pressure
30 seconds
The effect of Buzzy® administered during vaccine injection on the infant's SpO2 before vaccine injection.
Time Frame: 30 seconds
SpO2
30 seconds
The effect of Buzzy® administered during vaccine injection on the infant's SpO2 after vaccine injection.
Time Frame: 30 seconds
SpO2
30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Okan Univesitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2018

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

June 30, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 27, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018-17-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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