An interventional study of Administering oral breast milk in a supportive position and Administering oral 10% dextrose in a supportive position in Newborn Care, Pain Management and Physiological Parameters During Newborn Care İn Newborn's, sponsored by Mersin University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 32 Weeks to 37 Months. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Mersin University · Not applicable, Interventional, and Supportive care
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.
Aim: This study aims to determine the primary effect of oral breast milk, 20% dextrose, and 10% dextrose solutions-administered alongside supportive positioning methods during routine heel lancing blood sampling (within the Neonatal Screening Program)-on pain scores in premature newborns admitted to the NICUs. Secondarily, it aims to evaluate the effects of these interventions on heart rate and oxygen saturation variables.
Hypotheses: The research hypothesizes that there is a statistically significant difference between the oral breast milk, 20% dextrose, and 10% dextrose solution groups (applied with supportive positioning) regarding pain scores (H1a), heart rate (H1b), and oxygen saturation levels (H1c) during the heel lancing procedure.
Study Design: The study will be conducted using a single-center, parallel-group, randomized controlled trial design.
Study Location: The research will take place in the Neonatal Intensive Care Unit of Mersin University Hospital.
NICUs Characteristics: The unit features a traditional open-bay design comprising two wards. It provides level 4a care and has a total incubator capacity of 27.
Work Environment and Care Approach: As a tertiary referral center, the NICUs operates on two shifts (08:00-16:00 and 16:00-08:00), with a nurse-to-infant ratio ranging from 1:1 to 1:3. The unit adopts a family-centered individualized developmental care approach. The Turkish version of the Neonatal Pain, Agitation, and Sedation Scale (N-PASS) is routinely used to evaluate and record pain scores during shift changes and interventional procedures.
Study Population: The study population will consist of premature newborns admitted to the Mersin University Hospital NICU who are scheduled for routine heel prick blood sampling.
Sample Size: The sample size was determined via a priori power analysis using G*Power 3.1.9.4. Based on the effect size (d=0.92) from Brovedani et al. (2007), a minimum of 26 infants per group is required to detect a statistically significant difference with a 5% type I error margin (α = 0.05) and 90% power (1-β = 0.90).
Attrition Allocation: To account for potential dropouts and confounding variables, the sample size was increased by 20%. Consequently, the study will include a total of 96 premature newborns, with 32 infants assigned to each of the three intervention groups.
Data Collection Tools and Forms
Study Implementation Steps
Information regarding the duration of the procedure, the duration of the baby's crying, and heart rate and saturation before, during, and after the procedure will be obtained from camera recordings.
Analysis of Research Data: A statistical software package will be used to analyze the research data. The statistical significance level has been set at 0.05. Kolmogrow-Smirnov and Shapiro-Wilk tests will be used for normality analysis of dependent variables. Chi-square and mean comparison tests will be used to determine the similarity of groups. Appropriate parametric or non-parametric tests will be used to compare intra-group and between-group means, depending on whether the distribution is normal. In case of differences in between-group means, the appropriate effect size will be used according to the test family. Agreement and correlation analyses will be performed between N-PASS score evaluators. Additionally, post-hoc power analysis will be used to test whether the study was conducted with an adequate sample size. Effect Size: Cohen's d coefficient will be calculated to determine the strength of the difference between the groups.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 96 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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supportive positioning techniques during routine heel prick blood sampling and oral breastfeeding.
Behavioral: Administering oral breast milk in a supportive position
Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling.
Behavioral: Administering oral 10% dextrose in a supportive position
Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling.
Behavioral: Administering oral 20% dextrose in a supportive position
Administering oral breast milk in a supportive position
Application of 10% dextrose solution with supportive positioning during routine heel prick blood sampling.
Application of 20% dextrose solution with supportive positioning during routine heel prick blood sampling.
Change in the mean score of neonatal pain, agitation and sedation scale
The Neonatal Pain, Agitation, and Sedation Scale has a maximum score of 10, a minimum score of 0, and no lower limit. It is generally interpreted that "the higher the score on the scale, the more pain the baby is in."
Time frame: During the procedure
The effect of orally administered breast milk, 10% and 20% dextrose solutions, along with supportive positioning techniques during heel prick blood sampling in premature infants, on heart rate.
The effect of orally administered breast milk, 10% and 20% dextrose solutions, along with supportive positioning techniques during heel prick blood sampling in premature infants, on heart rate.
Time frame: During the procedure
The effect of supportive positioning techniques during heel prick blood sampling in premature infants, along with orally administered breast milk, 10% and 20% dextrose solutions, on respiratory rate.
The effect of supportive positioning techniques during heel prick blood sampling in premature infants, along with orally administered breast milk, 10% and 20% dextrose solutions, on respiratory rate.
Time frame: During the procedure
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