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

NCT05657977 | Completed

• 1 other identifier: 1234
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• First inclusion criteria eligible 20 newborn will be add this study.

  The saliva-specific Enzyme-Linked ImmunoSorbent Assay (ELISA) will be used for the study, for determine research results (pretest, posttest)

  up to 2 months

Study Arms (2)

Pretest

NO INTERVENTION

Pretest: The newborn connected to nCPAP will be placed in the supine position and slight extension position on the neck of the newborn to ensure airway patency. The first saliva sample will be taken to measure cortisol level in the 30th minute after the first cry from the newborn who is connected to nasal CPAP. Immediately after the saliva sample is taken in pretest group, the stress level determined by using the "neonatal stress scale", vital signs (respiration, heart rate, oxygen saturation), saliva sample collection time will be recorded on the chart.

Posttest, swaddling

EXPERIMENTAL

Posttest: The swaddling method will be applied to the newborn after the first saliva sample is taken. A second saliva sample will be taken 30 minutes after swaddling to measure cortisol level. Immediately after the saliva sample is taken in posttest group, the stress level determined by using the "neonatal stress scale", vital signs, saliva sample collection time will be recorded on the chart.

Other: nonpharmacologic intervention (swaddling)

Interventions

nonpharmacologic intervention (swaddling) OTHER

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.

Posttest, swaddling

Eligibility Criteria

• Age: 10 Minutes - 5 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Just one researcher has to blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The one-group, pretest, posttest research design.

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: December 20, 2022
• Study Start: December 30, 2022
• Primary Completion: February 28, 2023
• Study Completion: June 1, 2023
• Last Updated: July 12, 2023

Record last verified: 2022-09

Locations

TU (1)