Effects of Swaddling and Nesting on Pain and Stress in Newborns
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorKutahya Health Sciences University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Taking cortisol-containing medication during the antenatal period
Taking narcotics during the antenatal period
Having chorioamnionitis
Having a metabolic disorder (adrenal insufficiency, etc.)
Trial design
Design model
Parallel
Treatments tested in this trial
swaddling
BehavioralSaliva 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
BehavioralSaliva 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Swaddling GroupExperimental treatment 1 intervention
Group B: Nesting GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
before swaddling and nesting (t1), during application (5th minute) (t2), and 30 minutes after the swaddling and nesting method was applied (t3)Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Kütahya Health Sciences UniversityRecruiting Merkez, KütahyaTurkey (Türkiye)
Sponsors and contacts
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Source ClinicalTrials.gov