Trials / Completed
CompletedNCT04990648
Buzzy® Application in Pain
The Effect of Buzzy® Application on the Pain Level During Vaccine Injection in Infants
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Okan University · Academic / Other
- Sex
- All
- Age
- 12 Months – 12 Months
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-11-15
- Primary completion
- 2019-05-15
- Completion
- 2019-05-15
- First posted
- 2021-08-04
- Last updated
- 2021-08-04
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04990648. Inclusion in this directory is not an endorsement.