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Recruiting Not applicable

Effects of Swaddling and Nesting on Pain and Stress in Newborns

NCT07335263 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-02-17
Last updated
2026-07-28

Condition(s) studied

StressNon Pharmacological InterventionNewborn Diseases

Investigational drug(s) / intervention(s)

swaddlingNesting

swaddling: Saliva samples will be collected before the swaddling method is applied (t1), during application (5th minute) (t2), and 30 minutes after the swaddling method is applied (t3). Heart rate, respiratory rate, and partial oxygen pressure values, as well as pain and stress levels (ALPS-Neo), will be recorded by two researchers.

Nesting: Saliva samples will be collected before the nesting method is applied (t1), during application (5th minute) (t2), and 30 minutes after the nesting method is applied (t3). Heart rate, respiratory rate, and partial oxygen pressure values, as well as pain and stress levels (ALPS-Neo), will be recorded by two researchers.

Study summary

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.

Eligibility

Sex
ALL
Min age
0 Days
Max age
28 Days
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Determining pain and stress scores in newborns based on measurement times — before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3)
    The ALPS-Neo Neonatal Pain and Stress Assessment Scale (ALPS-Neo) score was recorded by the researcher before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3). The ALPS-Neo is a 3-point Likert-type scale consisting of 5 items: the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made through observation. As the score increases, stress and pain increase. The assessment results indicate that a score of 3-5 points indicates mild pain and stress, while a score above 5 points indicates severe pain and stress.

Trial sites (1)

FacilityCityRegionStatus
Kütahya Health Sciences University Merkez Kütahya Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07335263 on ClinicalTrials.gov ↗ ← All trials in Turkey