Effects of Swaddling and Nesting on Pain and Stress in Newborns

NCT07335263 | Recruiting

• 1 other identifier: 2025/01-29
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress; Non Pharmacological Intervention; Newborn Diseases

Outcome Measures

Primary Outcomes (1)

• Determining pain and stress scores in newborns based on measurement times

  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.

  before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3)

Study Arms (2)

Swaddling Group

EXPERIMENTAL

Swaddling method, a soft-textured, 100% cotton, square-shaped (100×100 cm, 110 g) fabric blanket that does not irritate the newborn's skin will be used. The newborn will be placed on the blanket in a supine position, naked except for a diaper, with the top edge of the blanket aligned with the shoulders. The arms will be placed in an extension-adduction position and the upper body will be swaddled with the blanket. The lower section will be wrapped with the legs in flexion and abduction, leaving space at the bottom for the feet to move freely and ensuring that the wrapping is not too tight. The baby's head will be allowed to move freely.

Behavioral: Nesting

Nesting Group

EXPERIMENTAL

Nesting method, swaddling devices covered with 100% cotton fabric, which support the intrauterine position and are routinely used in the neonatal intensive care unit, will be used. The swaddling device is confined with soft padding materials to support the baby's neck and body. The arms of the newborn placed in the supine position will be brought into the extension-adduction position and secured with soft elastic straps, and the baby's surroundings will be safely restricted. This method will ensure that the baby remains in a physiological and comfortable position.

Behavioral: swaddling

Interventions

swaddling BEHAVIORAL

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 Group

Nesting BEHAVIORAL

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.

Swaddling Group

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University

Merkez, Kütahya, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Canan Sümeyra Özyurt, Asist. Prof. Dr., PHD

CONTACT

05458125720; canansumeyra.gun@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The focus of conducting a blinded clinical trial is to eliminate bias in participants, researchers, or those evaluating the results (Bhide et al., 2018). In this study, blinding of researchers is not possible because they personally performed the procedures in the study groups in the neonatal intensive care unit. The saliva samples collected in the study and other collected data will be blinded to both the ELISA technician and the statistician by assigning different group names.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: February 17, 2025
• Primary Completion: January 6, 2026
• Study Completion: March 13, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)