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Non-Pharmacological Methods in Heel Lance

NCT07348731 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-05

No results posted yet for this study

Summary

This randomized controlled study was designed to compare the effects of Warm Foot Bath, ShotBlocker®, and Buzzy®-applied prior to heel lance-on the vital signs of newborns. Heel lance is one of the most frequently performed invasive procedures during the neonatal period, and the pain and stress experienced during the procedure may lead to alterations in vital parameters such as heart rate, respiratory rate, and oxygen saturation. Therefore, identifying non-pharmacological, safe, and feasible pain management methods is essential for enhancing the quality of nursing care.

Data will be collected at three time points: before, during, and after the procedure, and changes in heart rate, respiratory rate, and SpO₂ will be recorded. With parental consent, the procedure will be video-recorded before, during, and after heel lance; the recordings will be anonymized and shared with experts for pain assessment. Additionally, the infant's crying duration and time to bleeding cessation will also be evaluated.

Conditions

  • Heel Lance Procedures

Interventions

BEHAVIORAL

Foot bath

The infant's foot designated for blood sampling will be immersed up to the mid-calf level in water adjusted to 37-38°C, using a thermometer for confirmation, and kept there for 5 minutes. The heel lance procedure will then be performed by the nurse working in the clinic, following the standard clinical routine. The video recording will be stopped once bleeding has ceased at the end of the procedure. The video recordings obtained before, during, and after the procedure will be reviewed, and the infant's pain scores will be assessed by two independent experts.

Sponsors & Collaborators

  • Atlas University

    lead OTHER

Principal Investigators

  • sermin dinç, Dr. · Atlas University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Days
Max Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-25
Primary Completion
2026-02-25
Completion
2026-05-15

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 NCT07348731 on ClinicalTrials.gov