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Effects of Swaddling and Nesting on Pain and Stress in Newborns

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 28, 2026 (before its estimated September 6, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 8 months later Jan 6, 2026 → Sep 6, 2026
See other at-risk trials from Kutahya Health Sciences University

Record History

  1. Notable Primary completion pushed from Jan 6, 2026 to Sep 6, 2026
    • Study completion pushed from Mar 13, 2026 to Dec 13, 2026
    v3
  2. Minor Primary completion date changed from estimate of Jan 15, 2026 to Jan 6, 2026
    • Study completion date: Mar 15, 2026 to Mar 13, 2026
    • Start date: Nov 16, 2025 to Feb 17, 2025
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07335263
Lead Sponsor Kutahya Health Sciences University
Conditions
(from sponsor)
Stress, Non Pharmacological Intervention, Newborn Diseases
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov