Swaddling and Facilitated Tucking During Nasal CPAP Application
NCT ID: NCT07077148
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
114 participants
INTERVENTIONAL
2025-05-01
2025-12-30
Brief Summary
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Detailed Description
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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 2025 and October 2025.
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 2025 and October 2025. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Facilitated tucking group
Newborns in this group will be placed in the facilitated tucking position during nasal CPAP application.
Facilitated tucking
The upper and lower extremities of the newborns are taken to the midline and positioned in the womb.
Swaddling group
Newborns in this group will be swaddled during nasal CPAP application.
Swaddling
The baby is swaddled using the cloths used in the neonatal intensive care unit.
Control group
newborns in this group will receive standard care.
No interventions assigned to this group
Interventions
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Facilitated tucking
The upper and lower extremities of the newborns are taken to the midline and positioned in the womb.
Swaddling
The baby is swaddled using the cloths used in the neonatal intensive care unit.
Eligibility Criteria
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Inclusion Criteria
* Newborns between 34 0/7 weeks and 36 6/7 weeks of gestation,
* Those without congenital anomalies,
* Those without a health problem that prevents positioning,
* Those without mental or neurological problems.
Exclusion Criteria
* Newborns who received opioids or sedatives 4 hours before the procedure,
* Intubated newborns
* Newborns with a gestational age greater than 37 weeks
ALL
No
Sponsors
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Recep Tayyip Erdogan University
OTHER
Responsible Party
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Gamzegül ALTAY
Assistant Professor of Child Health and Disease Nursing
Locations
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Recep Tayyip Erdogan University
Rize, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Gamze ALTAY
Identifier Type: -
Identifier Source: org_study_id
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