Ignite Creation Date:
2024-05-06 @ 6:25 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05657977
Status:
COMPLETED
Last Update Posted:
2023-07-12
First Post:
2022-09-01
Brief Title:
The Effect of Swaddling Method on Stress Level in Newborns Administration to Nasal CPAP
Sponsor:
Kutahya Health Sciences University
Organization:
Kutahya Health Sciences University
Study Overview
Official Title:
The Effect of Swaddling Method on Stress Level in Newborns Administration to Nasal CPAP
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transient tachypnea of newborn TTN causes 425-60 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 60min 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
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 CPAPnoninvasive 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 babys stress level is high
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 CPAPnoninvasive 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 babys stress level is high
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None