Buzzy Application During Heel Blood Collection in the Newborn
The Effect of Buzzy Application on Pain and Comfort Level During Heel Blood Collection in Newborns: A Randomized Controlled Study
Objective The aim of this study was to evaluate the effects of Buzzy device application during heel prick blood collection on pain level and comfort in newborns.
Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between September and November 2024 using a randomized controlled experimental design. The study sample consisted of 80 newborn infants born at 37-42 weeks gestational age and within the first 28 days of birth (Buzzy group: n = 40, control group: n = 40). The Buzzy group was treated by placing the Buzzy device approximately 30 seconds before heel prick blood collection. In the control group, routine heel prick was performed without any application. Neonatal introduction form, Neonatal Infant Pain Scale and Neonatal Comfort Behavior Scale were used for data collection.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tuşba
-
VAN, Tuşba, Turkey, 65000
- Van Yuzuncu Yıl University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those in the neonatal period between 0-28 days,
- voluntary participation of the parent,
- between 37-42 weeks of gestational age
- babies with vital signs within normal limits
Exclusion Criteria:
- The integrity of the skin in the area where the device was to be implanted was compromised,
- Nerve damage or deformity in the extremity to be heel bled,
- Genetic - with a congenital anomaly or congenital metabolic disorder,
- undergoing cardiopulmonary resuscitation,
- No heel prick on the first attempt,
- with osteogenesis imperfecta and infants given analgesics in the last 6 hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
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Experimental: Buzzy
|
Buzzy application during heel prick blood collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Neonatal Infant Pain Scale
Time Frame: pre-test post-test (approximately three months)
|
min-max (0-7) , fewer points is a good result
|
pre-test post-test (approximately three months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Buzzy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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