Clinical Trial

Effects of Swaddling and Nesting on Pain and Stress in Newborns

Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-01-06 -> 2026-09-06 2026-07-29
minor Completion pushed: 2026-03-13 -> 2026-12-13 2026-07-29
Trial Details
NCT Number NCT07335263
Lead Sponsor Kutahya Health Sciences University
Conditions Stress, Non Pharmacological Intervention, Newborn Diseases
Enrollment 100 participants
Start Date 2025-02-17
Primary Completion 2026-09-06 (estimated)
Study Completion 2026-12-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-28