Actively Recruiting

Phase Not Applicable
Age: 1Day - 1Month
All Genders
Healthy Volunteers
NCT07081048

Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns

Led by Tarsus University · Updated on 2025-07-23

159

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Aim: The study was designed to determine the effect of Buzzy® and Shotbloker® application on pain and comfort levels in newborns during heel pricking. Method:The study was a randomised controlled trial. The study sample consisted of 159 newborns (Buzzy: 53, Shotbloker: 53, control: 53) who had heel pricks between March 2025 and December 2025 at the Samandağ State Hospital Neonatal Care Unit. The data collection tools used will be the Newborn Information Form, the Newborn Pain Scale, the Newborn Comfort Behaviour Scale, and the Buzzy® and Shotbloker® devices. In the intervention group, the Buzzy® and Shotbloker® devices will be applied before and after heel pricking, while the control group will receive routine care. The infants' pain and comfort levels will be assessed by the nurse before and after the procedure.

CONDITIONS

Official Title

Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns

Who Can Participate

Age: 1Day - 1Month
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • The baby must be full-term (38-42 weeks)
  • No analgesic medication given within 8 hours before the procedure
  • No pain before the procedure
  • No chronic or metabolic disease
  • Born at least 24 hours before participation
  • Baby must be in the hospital during the study period
Not Eligible

You will not qualify if you...

  • Baby is not full-term
  • Analgesic medication was given within 8 hours before the procedure
  • Baby has a chronic or metabolic disease
  • Baby requires oxygen support
  • Baby cannot be fed orally
  • Baby is not in the hospital during the study dates or parents do not agree to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tarsus University

Mersin, Turkey (Türkiye), 33400

Actively Recruiting

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Research Team

D

Duygu Sönmez Düzkaya, PhD

CONTACT

G

Gözde Özkan, BSC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

3

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