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Pain and Comfort Levels During Heel Stick Blood Sampling in Newborns

NCT07081048 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-07-23

No results posted yet for this study

Summary

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

  • Newborn

Interventions

OTHER

Buzzy®.Group

The ice pack, which has been removed from the deep freezer in advance, should be left at room temperature for 10 minutes, and the hole in the ice pack should be placed on the hook behind the Buzzy® will be placed on the lateral side of the left heel and activated for 30 seconds. After 30 seconds, Buzzy® will be pulled up 1 centimetre (cm), and the heel will be punctured with a sterile lancet to collect blood on the Guthrie card. After the heel blood collection procedure, Buzzy® will be pulled back to the punctured heel area and left for another 30 seconds.

OTHER

ShotBlocker Group

ShotBlocker will be placed on the designated area for collecting the baby's heel blood. After ensuring that the protrusions of the ShotBlocker are in contact, pressure will be applied for 20 seconds. The heel will be punctured with a sterile lancet in the area designed for applying the ShotBlocker, and the ShotBlocker will be removed from the area. The blood collected will be collected on Guthrie paper.

Sponsors & Collaborators

  • Tarsus University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07081048 on ClinicalTrials.gov