This study aims to investigate the effects of swaddling and cradling methods on pain and stress levels in newborn infants receiving respiratory support.
Infants receiving respiratory support in the neonatal intensive care unit may experience stress and discomfort during treatment. In this study, two different care methods that help infants feel more comfortable and secure will be scientifically compared. Only one of the Swaddling or Nesting methods will be applied to the newborns participating in the study. These methods are comfort-enhancing care practices routinely used in neonatal intensive care that do not harm the baby. The newborn's heart rate, respiratory rate, oxygen level, pain and stress symptoms will be closely and safely monitored by the healthcare team. A pain-free saliva sample will be collected to assess the newborn's stress level. It does not involve needles, does not hurt, and takes approximately 2 minutes. Pain and stress levels will be assessed in a multifaceted manner using clinical observation, physiological parameters, and saliva cortisol levels. The study aims to contribute to the strengthening of evidence-based non-pharmacological care practices in neonatal intensive care.
Who can participate
Age range
0 Days – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Birth week greater than 35 weeks and birth weight greater than 2000 grams
* Requirement for nasal CPAP/noninvasive mechanical ventilation
* Legal guardians' consent to participate in the study
* Postnatal diagnosis of transient tachypnea of the newborn
Exclusion Criteria:
Mother:
* Taking cortisol-containing medication during the antenatal period
* Taking narcotics during the antenatal period
* Having chorioamnionitis
* Having a metabolic disorder (adrenal insufficiency, etc.)
Newborn:
* Amniotic fluid stained with meconium
* Being intubated
* Having an Apgar score below 6
* Receiving analgesic or narcotic drugs for sedation
* The newborn receiving cortisol-containing medication
* Being unable to obtain a saliva sample or the sample being contaminated with blood
* Signs of nasal injury during noninvasive mechanical ventilation
* Congenital defects (spina bifida, gastroschisis, etc.) that prevent positioning using the swaddling or cradling methods
* Resuscitation
* Cerebral hypoxia-ischemia
* Non-respiratory causes (congenital pneumonia, respiratory distress syndrome, congenital heart disease, hypocalcemia, persistent hypoglycemia, development of sepsis)
* Hypocalcemia (low calcium level detected in blood gas sample taken while establishing an intravenous line prior to nCPAP)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determining pain and stress scores in newborns based on measurement times
Timeframe: before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3)