Effects of Swaddling and Nesting on Pain and Stress in Newborns
Recruiting now · Not applicable
Conditions studied: Stress, Non Pharmacological Intervention, Newborn Diseases
In brief
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.
Key facts
- Study ID
- NCT07335263
- Run by
- Kutahya Health Sciences University
- People needed
- 100
- Starts
- 2025-02-17
- Expected to finish
- 2026-12-13
- Last updated by the study team
- 2026-07-28
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Kütahya Health Sciences University — Merkez, Kütahya, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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