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

NCT05657977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-07-12

No results posted yet for this study

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.

Conditions

  • Nursing Caries
  • Newborn Illness
  • Nurse's Role

Interventions

OTHER

nonpharmacologic intervention (swaddling)

Swaddling method;The newborn will be placed on a square fabric blanket in the flexion and abduction position and will be loosely swaddled with a blanket.

Sponsors & Collaborators

  • Kutahya Health Sciences University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Minutes
Max Age
5 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-30
Primary Completion
2023-02-28
Completion
2023-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05657977 on ClinicalTrials.gov