Buzzy® Application in Pain

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990648
• Other study ID #: 2018-17-02
• Status: Completed
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: July 2021
• Source: Istanbul Okan Univesitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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 2??? x 1??? x ??? (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.

Locations

Country	Name	City	State
Turkey	Istanbul Okan University	Tuzla	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Okan Univesitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of Buzzy® administered during vaccine injection on the infant's pain level before vaccine injection.	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
Primary	The effect of Buzzy® administered during vaccine injection on the infant's pain level during vaccine injection.	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
Primary	The effect of Buzzy® administered during vaccine injection on the infant's pain level after vaccine injection.	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
Primary	The effect of Buzzy® administered during vaccine injection on the infant's pulse before vaccine injection.	pulse rate	30 seconds
Primary	The effect of Buzzy® administered during vaccine injection on the infant's pulse after vaccine injection.	pulse rate	30 seconds
Primary	The effect of Buzzy® administered during vaccine injection on infant blood pressure before vaccine injection.	blood pressure	30 seconds
Primary	The effect of Buzzy® administered during vaccine injection on infant blood pressure after vaccine injection.	blood pressure	30 seconds
Primary	The effect of Buzzy® administered during vaccine injection on the infant's SpO2 before vaccine injection.	SpO2	30 seconds
Primary	The effect of Buzzy® administered during vaccine injection on the infant's SpO2 after vaccine injection.	SpO2	30 seconds