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Clinical Trials/NCT06773325
NCT06773325
Completed
N/A

The Effect of Buzzy Application on Pain and Comfort Level During Heel Blood Collection in Newborns: A Randomized Controlled Study

Yuzuncu Yıl University1 site in 1 country80 target enrollmentSeptember 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Yuzuncu Yıl University
Enrollment
80
Locations
1
Primary Endpoint
The Neonatal Infant Pain Scale
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
November 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Yuzuncu Yıl University
Responsible Party
Principal Investigator
Principal Investigator

Veysel Can

Asst. Prof.

Yuzuncu Yıl University

Eligibility Criteria

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

Outcomes

Primary Outcomes

The Neonatal Infant Pain Scale

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

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

Study Sites (1)

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