Actively Recruiting
Effects of Swaddling and Nesting on Pain and Stress in Newborns
Led by Kutahya Health Sciences University · Updated on 2026-01-26
100
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effects of Swaddling and Nesting on Pain and Stress in Newborns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born at 35 weeks of gestation or later and weighing more than 2000 grams
- Requires nasal CPAP or noninvasive mechanical ventilation
- Legal guardian has given consent for participation
- Diagnosed with transient tachypnea of the newborn after birth
You will not qualify if you...
- Mother took cortisol medication during pregnancy
- Mother used narcotics during pregnancy
- Mother has chorioamnionitis
- Mother has a metabolic disorder such as adrenal insufficiency
- Amniotic fluid stained with meconium
- Baby is intubated
- Apgar score below 6
- Baby receiving analgesic or narcotic sedation drugs
- Baby receiving cortisol-containing medication
- Unable to obtain saliva sample or sample contaminated with blood
- Signs of nasal injury during noninvasive ventilation
- Congenital defects preventing swaddling or cradling (e.g., spina bifida, gastroschisis)
- Baby required resuscitation
- Cerebral hypoxia-ischemia
- Non-respiratory conditions such as congenital pneumonia, respiratory distress syndrome, congenital heart disease, hypocalcemia, persistent hypoglycemia, or sepsis
- Low calcium levels detected before starting nasal CPAP
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kütahya Health Sciences University
Merkez, Kütahya, Turkey (Türkiye)
Actively Recruiting
Research Team
C
Canan Sümeyra Özyurt, Asist. Prof. Dr., PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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