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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06773325
Enrollment
80
Registered
2025-01-14
Start date
2024-09-01
Completion date
2024-11-30
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Buzzy

Brief summary

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.

Interventions

BEHAVIORALBuzzy application

Buzzy application during heel prick blood collection

Sponsors

Yuzuncu Yil University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The Neonatal Infant Pain Scalepre-test post-test (approximately three months)min-max (0-7) , fewer points is a good result

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026