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Search / Trial NCT05657977

The Effect of Swaddling Method on Stress Level in Newborns Administration to Nasal CPAP

Launched by KUTAHYA HEALTH SCIENCES UNIVERSITY · Dec 19, 2022

Trial Information

Current as of January 16, 2025

Completed

Keywords

ClinConnect Summary

The aim of the proposed study is to determine the effect of the swaddling method applied to newborns in noninvasive mechanical ventilators on the stress level, by using the neonatal stress scale and salivary cortisol levels.

Type of the research: The research was planned to be conducted in a single group with a pre-test, post-test pattern experimental type.

Research variables Independent variable: Swaddling method. Dependent Variables: The stress felt by the newborn and the salivary cortisol level

The Hypothesis of the Study: H1: Post-intervention (swaddling method) stress and cortisol l...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Birth week greater than 35 and birth weight greater than 2000 g,
  • Need for nasal CPAP/noninvasive mechanical ventilator,
  • Legal guardians' consent to participate in the research,
  • Diagnosis of neonatal transient tachypnea after delivery.
  • Exclusion Criteria:
  • Mother:
  • Taking cortisol-containing medication during the antenatal period
  • Taking drugs during the antenatal period
  • Being chorioamnionitis
  • Metabolic disease (adrenal insufficiency, etc.)
  • Newborn:
  • Amniotic fluid stained with meconium
  • Intubation
  • Apgar score below 6
  • Taking analgesic and narcotic drugs for sedation
  • Newborn taking cortisol-containing medication
  • Inability to obtain a saliva sample or if it is contaminated with blood
  • Signs of nasal injury during noninvasive mechanical ventilation
  • Congenital defects that will prevent the wrapping method (spina bifida, gastroschisis, etc.)
  • Performing resuscitation
  • Newborns with cerebral hypoxia-ischemia
  • Non-respiratory (congenital pneumonia, respiratory distress syndrome, congenital heart diseases, hypocalcemia, persistent hypoglycemia) causes,
  • Development of neonatal sepsis (If sepsis develops in the newborn within the postnatal 48 hours, the baby will be removed from the sample group. Whole blood, biochemistry, hemoculture, and serology tests are performed at the postnatal 24th hour in the routine practice of the unit. The patient will be excluded from the sample after laboratory tests are performed.)
  • Hypocalcemia (low calcium level as a result of the blood gas sample taken while opening the vascular access before nCPAP is connected)

About Kutahya Health Sciences University

Kutahya Health Sciences University is a premier academic institution dedicated to advancing healthcare through innovative research and clinical trials. Committed to fostering excellence in medical education and patient care, the university collaborates with leading researchers and healthcare professionals to conduct cutting-edge studies aimed at improving health outcomes. With a focus on translating scientific discoveries into practical applications, Kutahya Health Sciences University plays a vital role in shaping the future of healthcare through rigorous clinical research and interdisciplinary collaboration.

Locations

Kutahya, , Turkey

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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