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Clinical Trials/NCT04990648
NCT04990648
Completed
N/A

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

Okan University1 site in 1 country60 target enrollmentNovember 15, 2018
ConditionsHealthy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy
Sponsor
Okan University
Enrollment
60
Locations
1
Primary Endpoint
The effect of Buzzy® administered during vaccine injection on the infant's pain level during vaccine injection.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2018
End Date
May 15, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Okan University
Responsible Party
Principal Investigator
Principal Investigator

Ozge Siktas

Principal Investigator, RN, MSc

Okan University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)).

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

Time Frame: 30 seconds

blood pressure

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

Time Frame: 30 seconds

blood pressure

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

Time Frame: 30 seconds

SpO2

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)).

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

Time Frame: 30 seconds

pulse rate

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)).

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

Time Frame: 30 seconds

pulse rate

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

Time Frame: 30 seconds

SpO2

Study Sites (1)

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