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CompletedNCT06773325Updated Jan 14, 2025

Buzzy Application During Heel Blood Collection in the Newborn

An interventional study of Buzzy application in Buzzy, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged 0 Days to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Yuzuncu Yıl University · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
0 Days to 28 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Buzzy
03

In context

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 28 Days
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Buzzy

    Behavioral: Buzzy application

  • No intervention
    Control

Interventions

  • BehavioralBuzzy application

    Buzzy application during heel prick blood collection

06

What researchers measure

Primary outcomes

  1. The Neonatal Infant Pain Scale

    min-max (0-7) , fewer points is a good result

    Time frame: pre-test post-test (approximately three months)

07

Study locations

1 site
  • Van Yüzüncü Yıl University
    VAN, Tuşba 65000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06773325
Lead sponsor
Yuzuncu Yıl University
Responsible party
Veysel Can (Asst. Prof., Yuzuncu Yıl University) — Principal investigator
First posted
Jan 14, 2025
Start date
Sep 1, 2024
Primary completion
Nov 20, 2024
Completion
Nov 30, 2024
Last update
Jan 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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