Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05657977 |
| Other study ID # |
1234 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 30, 2022 |
| Est. completion date |
June 1, 2023 |
Study information
| Verified date |
September 2022 |
| Source |
Kutahya Health Sciences University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
