NCT05657977

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Kutahya Health Sciences University · Academic / Other
• Sex: All
• Age: 10 Minutes – 5 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

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 levels of newborns on CPAP/noninvasive mechanical ventilator are lower than pre-intervention stress and cortisol levels. Neonatal Stress Scale: The scale consists of 8 sub-dimensions (facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, posture), and 3-point Likert type. The items in the scale were graded according to the level of stress and grouped into 8 subgroups. In scoring, each subgroup is evaluated between 0-2 points. A minimum of 0 points and a maximum of 16 points are taken from the scale. The baby whose condition is stable and balanced will get a score of 0 from the scale. A high total score from the scale indicates that the baby's stress level is high.

Conditions

• Nursing Caries
• Newborn Illness
• Nurse's Role

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-30
• Primary completion: 2023-02-28
• Completion: 2023-06-01
• First posted: 2022-12-20
• Last updated: 2023-07-12

Locations

1 site across 1 country: Turkey (Türkiye)