Buzzy® Application in Pain
- Conditions
- Healthy
- Interventions
- Device: Buzzy
- Registration Number
- NCT04990648
- Lead Sponsor
- Okan University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- It can be listed as having a body temperature above 37.5.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Buzzy group Buzzy 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.
- Primary Outcome Measures
Name Time Method The effect of Buzzy® administered during vaccine injection on the infant's pain level during vaccine injection. 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. 30 seconds blood pressure
The effect of Buzzy® administered during vaccine injection on infant blood pressure after vaccine injection. 30 seconds blood pressure
The effect of Buzzy® administered during vaccine injection on the infant's SpO2 after vaccine injection. 30 seconds SpO2
The effect of Buzzy® administered during vaccine injection on the infant's pain level before vaccine injection. 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. 30 seconds pulse rate
The effect of Buzzy® administered during vaccine injection on the infant's pain level after vaccine injection. 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. 30 seconds pulse rate
The effect of Buzzy® administered during vaccine injection on the infant's SpO2 before vaccine injection. 30 seconds SpO2
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Istanbul Okan University
🇹🇷Tuzla, Istanbul, Turkey