Buzzy® Application in Pain

NCT04990648 | Completed DMC

• 1 other identifier: 2018-17-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pain; Vaccination; Baby; Buzzy; Pediatric nurse

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• The effect of Buzzy® administered during vaccine injection on the infant's pulse before vaccine injection.

  pulse rate

  30 seconds

• The effect of Buzzy® administered during vaccine injection on the infant's pulse after vaccine injection.

  pulse rate

  30 seconds

• The effect of Buzzy® administered during vaccine injection on infant blood pressure before vaccine injection.

  blood pressure

  30 seconds

• The effect of Buzzy® administered during vaccine injection on infant blood pressure after vaccine injection.

  blood pressure

  30 seconds

• The effect of Buzzy® administered during vaccine injection on the infant's SpO2 before vaccine injection.

  SpO2

  30 seconds

• The effect of Buzzy® administered during vaccine injection on the infant's SpO2 after vaccine injection.

  SpO2

  30 seconds

Study Arms (2)

Buzzy group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Buzzy DEVICE

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.

Buzzy group

Eligibility Criteria

• Age: 12 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Istanbul Okan University

Tuzla, Istanbul, 34959, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, RN, MSc

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: August 4, 2021
• Study Start: November 15, 2018
• Primary Completion: May 15, 2019
• Study Completion: May 15, 2019
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)