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Clinical Trial Summary

Pharmacological and non-pharmacological methods are used to control interventional pain in preterm newborns. Non-pharmacological methods should be preferred in the management of pain, especially during painful minor invasive procedures (blood collection, orogastric tube insertion, aspiration, etc.) applied during the day. Some of these methods are; kangaroo care, breast milk, fetal positioning, breastfeeding, listening to music and massage. Taking heel blood from babies who are being treated in the neonatal intensive care unit is among the duties, authorities and responsibilities of neonatal intensive care nurses. In addition, the effective management of pain by using non-pharmacological methods is among the professional ethical responsibilities of nurses working in neonatal intensive care units. While fulfilling these responsibilities, nurses should conduct researches with high levels of evidence and benefit from the researches effectively. In this context, determining the most effective non-pharmacological method and activating it in a clinical setting form the basis of nursing practices. In this context, the aim of our research is; The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast milk and breast milk, and kangaroo care in reducing pain during heel blood collection in preterm newborns.


Clinical Trial Description

The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast milk and breast milk, and kangaroo care in reducing pain during heel blood collection in preterm newborns. The sample of the study will consist of late preterm newborns who meet the inclusion criteria of the study. It is envisaged that 40 babies will be included in the sample for each group. Randomization will be done in order to provide an equal number of samples for the intervention and control groups in the study. In the randomization to be made, the "simple randomization method" will be used in order to provide equal samples for all three groups. The data of the study will be collected by the clinical nurse working as a nurse in the clinic where the research is conducted, in accordance with the randomization scheme. Physiological parameters of all babies will be monitored on the monitor during the interventions. During the research, all groups will be video-recorded for 10 minutes before the procedure, during the procedure and for 5 minutes after the procedure. After the data of the study are collected, all video recordings will be examined by two researchers (a neonatal intensive care nurse and a neonatal intensive care specialist) and PIPP-R The scale will be filled in by these two independent observers. Descriptive statistics (mean, standard deviation) will be used for the quantitative variables of the research determined by measurement, and descriptive statistics (number, percentage) will be used for the qualitative variables determined by counting. The conformity of the data to be used with the normal distribution will be determined by the Shapiro-Wilk test. In paired comparisons between variables with two categories such as gender, t-test, Analysis of Variance will be applied to find the differences between variables with three or more categories such as group. Paired-sample t-test will be applied between dependent groups for the features that are significant as a result of the analysis of variance. Mann Whitney U test, Wilcoxon test and correlation analyzes will be used to evaluate the relationships between dependent and independent variables. Results will be evaluated at 95% confidence interval and p<0.05 significance level. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05431452
Study type Interventional
Source Suleyman Demirel University
Contact Serife Tutar
Phone +905053126429
Email serifeguven@sdu.edu.tr
Status Recruiting
Phase N/A
Start date March 1, 2022
Completion date June 1, 2024

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