Effects of Swaddling and Facilitated Tucking on Newborn Pain, Stress and Comfort Levels During Nasal CPAP Application
Effects of Swaddling and Facilitated Tucking on Newborn Pain, Stress and Comfort Levels During Nasal CPAP Application
This study was planned to determine the effects of fetal position and swaddling during nasal CPAP application on pain, stress level, comfort and physiological parameters of the newborn. The research is a randomized controlled trial. The study will be conducted in the neonatal intensive care unit of a Training and Research Hospital between May 2026 and December 2026. Newborns who meet the study criteria from the specified universe will constitute the sample of the study. "Newborn Identification Information Form", "ALPS Neo Neonatal Pain and Stress Assessment Scale", "Premature Baby Comfort Scale" and "Physiological Parameter Follow-up Form" will be used to collect data. will be used.
Type of Research: The research will be conducted in a randomized controlled experimental design.
Place and Time of the Research: The research will be conducted in the Neonatal Intensive Care Unit of a Training and Research Hospital between May 2026 and December 2026.
Research Universe and Sample: The universe of this research will consist of newborns receiving nasal CPAP support in the neonatal intensive care units of Recep Tayyip Erdoğan University Training and Research Hospital between May 2026 and December 2026. The newborns from the specified universe who meet the study criteria will constitute the sample of the study. The sample size in the research was calculated using the Gpower program. When the calculation was made with 3 groups (Experiment 1, Experiment 2, Control) and the effect size (d = 0.46), 5% margin of error (α = 0.05) and 99% power (1-β = 0.99), the sample size for each group was found to be 35 people. (Derince, 2016). In case of data loss, it was decided to collect data from a total of 114 newborns (38 fetal position, 38 swaddling, 38 control) by including a 10% spare sample in this number.
Randomization The randomization of the fetal position group, swaddling group and control groups will be determined with the research (https://www.randomizer.org/) program. In addition, after obtaining the ethics committee approval, the research registration number required for randomized controlled studies will be obtained from ClinicalTrials.gov.
Data Collection Tools to be Used in the Study: The Newborn Identification Information Form, ALPS Neo Newborn Pain and Stress Assessment Scale, Premature Baby Comfort Scale and Physiological Parameter Follow-up Form will be used to collect research data. The swaddle blanket used in the neonatal intensive care unit to swaddle babies and the towel support for fetal positioning and the baby care blankets used in the neonatal intensive care unit will be used as intervention tools in the study.
Nursing Interventions Nasal CPAP application applied to newborns will be performed in all groups (fetal position, swaddling and control group) in accordance with the clinical routine.
Data Collection The study will collect data from babies of parents who are admitted to the neonatal intensive care unit of a university hospital and who meet the inclusion criteria and agree to participate in the study. Since the "ALPS Neo Neonatal Pain and Stress Assessment Scale" and "Premature Infant Comfort Scale" to be used in data collection are observation-based scales, they will be filled out by both the researcher and the observer nurse. Data collection will be carried out before, during and after the procedure from each group (fetal position, swaddling and control group).
Ethical Principles of the Research In order to conduct the research, after receiving official institutional permission from the relevant institution, ethical approval will be obtained from the Ethics Committee of Recep Tayyip Erdoğan University Faculty of Medicine. The purpose of the study will be explained to the parents of newborns who meet the research group criteria, the questions asked will be answered and their verbal and written consent will be obtained. Parents will be informed that the data collected during the research will be processed confidentially and anonymously, will not be used outside the study in question and that they can withdraw from the study at any time. Since the research is based on the use of data obtained from humans and therefore, due to the necessity of protecting personal rights, the relevant ethical principles of "Informed Consent", "Voluntariness" and "Protection of Confidentiality" will be followed.
Inclusion Criteria:
Exclusion Criteria:
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