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Recruiting NCT05657977

The Effect of Swaddling Method on Stress Level in Newborns in Noninvasive Mechanical Ventilators

Conditions: Nursing Caries, Newborn Illness, Nurse's Role

Sex: All
Ages: 10 Minutes – 5 Hours
Phase: NA
Enrollment: 40
Sponsor: Kutahya Health Sciences University

Location: Turkey

Summary

Transient tachypnea of newborn (TTN) causes 42.5%-60% of non-infectious respiratory distress cases in newborns, it is seen in only 1% of all newborns. In the etiology of TTN, it results from the inability to effectively clear the fetal lung fluid immediately after birth. The most known risk factors of TTN are; prematurity, malpresentation, abnormal birth, premature rupture of the membrane, meconium aspiration, fetal distress, multiple pregnancy, male gender, and low Apgar score. TTN; It typically occurs in term and late preterm newborns within the first two hours of life. For the diagnosis of TTN, respiratory rate >60/min in the first 6-12 hours shows signs of groaning and retraction and improve spontaneously within a few days with 40% or less supportive oxygen therapy.However, in some rare cases, prolongation of symptoms, noninvasive mechanical ventilation support [nasal continuous positive airway pressure (nCPAP), nonsynchronized nasal intermittent mandatory ventilation (NIMV)] and in some cases invasive (intubated) mechanical ventilation may be required.Reducing pain and stress in mechanically ventilated infants is important for the prevention of complications that may occur in the future-early period and for recover process. While providing standard health care in the Neonatal Intensive Care Unit (NICU), sources of pain and stress should be identified and controlled. It is necessary to minimize the interventions that will cause pain and stress and to ensure that the newborn copes with the pain. In order to relieve pain and stress, various pharmacological (opioid, non-opioid analgesics) and non-pharmacological (breast milk, pacifier, kangaroo care, flexion posture, swaddling etc.) within the framework of family-centered care and individualized developmental care methods should be used. Pain control is a priority in neonatal nursing care, and it is the nurses; responsibility to select and implement a non-pharmacological intervention to reduce the level of pain. A limited number of studies have been found examining the effects of therapeutic touch and mothers voice on pain and comfort level in newborns, as a behavioral intervention, on relieving stress of body positioning in premature newborns who underwent nCPAP. There was no study found that the swaddling method applied during the procedure in patients followed up on nCPAP had an effect on reducing the stress level of newborns.

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 periodTaking drugs during the antenatal periodBeing chorioamnionitisMetabolic disease (adrenal insufficiency, etc.)Newborn:Amniotic fluid stained with meconiumIntubationApgar score below 6Taking analgesic and narcotic drugs for sedationNewborn taking cortisol-containing medicationInability to obtain a saliva sample or if it is contaminated with bloodSigns of nasal injury during noninvasive mechanical ventilationCongenital defects that will prevent the wrapping method (spina bifida, gastroschisis, etc.)Performing resuscitationNewborns with cerebral hypoxia-ischemiaNon-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)

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Source: ClinicalTrials.gov (NCT05657977). StuddyBuddy aggregates publicly available trial information.