The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants

NCT07716813 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-07-24

No results posted yet for this study

Summary

Pain, defined by the International Association for the Study of Pain as a subjective, sensory, and emotional experience, differs from nociception, which is merely a neural activity. Premature newborns, whose inhibitory fibers are not yet mature due to anatomical and physiological development and who have insufficient endogenous opioid release, experience painful stimuli much more intensely. The inability of this age group to verbally express pain makes the diagnosis, assessment, and management of pain entirely dependent on healthcare professionals. Pain that is not effectively managed leads to stress and loss of comfort in the short term, while in the long term it can cause permanent neurodevelopmental problems and alter the individual's pain threshold later in life.

Premature infants, especially those in Neonatal Intensive Care Units (NICUs), are exposed to invasive procedures that cause moderate to severe pain, such as heel prick tests, much more frequently than healthy term infants. In this context, pain management is a fundamental and essential nursing responsibility for the infant's neuroprotective developmental care. The literature shows that various non-pharmacological methods, such as oral sucrose, non-nutritive sucking (NNS), facilitated flexion, and wrapping, are used to alleviate pain during interventional procedures. Although more readily available in NICUs, studies on the effectiveness of oral glucose solutions are more limited compared to sucrose.

This research, designed to address this gap in the existing literature, aims to investigate the effect of "oral breast milk, 20%, and 10% dextrose solution administered with supportive positioning methods" on pain reduction during heel prick blood sampling in premature newborns. The results of this research are expected to contribute to the development of a new, easily applicable, effective, and evidence-based nursing intervention strategy for NICUs.

Conditions

  • Newborn Care
  • Pain Management
  • Physiological Parameters During Newborn Care İn Newborn's
  • Breast Milk
  • Premature

Interventions

BEHAVIORAL

Administering oral breast milk in a supportive position

Administering oral breast milk in a supportive position

BEHAVIORAL

Administering oral 10% dextrose in a supportive position

Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling.

BEHAVIORAL

Administering oral 20% dextrose in a supportive position

Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling.

Sponsors & Collaborators

  • Mersin University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
37 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-18
Primary Completion
2026-08-15
Completion
2026-09-30

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 NCT07716813 on ClinicalTrials.gov