Swaddling and Facilitated Tucking During Nasal CPAP Application

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRecep Tayyip Erdogan University

About this trial

This study was planned to determine the effects of fetal position and swaddling during nasal CPAP application on pain, stress level, comfort and physiological parameters of the newborn. The research is a randomized controlled trial. The study will be conducted in the neonatal intensive care unit of a Training and Research Hospital between May 2026 and December 2026. Newborns who meet the study criteria from the specified universe will constitute the sample of the study. "Newborn Identification Information Form", "ALPS Neo Neonatal Pain and Stress Assessment Scale", "Premature Baby Comfort Scale" and "Physiological Parameter Follow-up Form" will be used to collect data. will be used.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those receiving nasal CPAP support,

Newborns between 34 0/7 weeks and 36 6/7 weeks of gestation,

Those without congenital anomalies,

Those without a health problem that prevents positioning,

Disqualifiers

Those with pneumothorax,

Newborns who received opioids or sedatives 4 hours before the procedure,

Intubated newborns

Newborns with a gestational age greater than 37 weeks

Trial design

Design model

Parallel

Treatments tested in this trial

  • Facilitated tucking

    Behavioral

    The upper and lower extremities of the newborns are taken to the midline and positioned in the womb.

  • Swaddling

    Behavioral

    The baby is swaddled using the cloths used in the neonatal intensive care unit.

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: Facilitated tucking groupExperimental treatment 1 intervention
Group B: Swaddling groupExperimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

ALPS Neo Neonatal Pain and Stress Assessment Scale:

ALPS Neo Neonatal Pain and Stress Assessment Scale: The "ALPS Neo Neonatal Pain and Stress Assessment Scale" was developed by Lundqvist et al. in 2014, based on the individualized developmental care of the newborn, in order to assess pain and stress in premature and term newborns (Lundqvist et al., 2014). This scale was adapted to Turkish in 2017 and its validity and reliability study was conducted by Ceylan and Bolışık. ALPS Neo is a 3-point Likert-type scale consisting of 5 items, namely "facial expression, breathing pattern, tone of extremities, hand/foot activities and activity level" of the newborn, and measurements are made through observation. As the scores obtained increase, pain and stress in the newborn increase. As a result of the evaluation, "3-5 points indicate the presence of mild pain and stress, and 5 points and above indicate the presence of severe pain and stress" (Ceylan \& Bolışık, 2017).

Time frame
6 month
2

Premature Infant Comfort Scale

The comfort scale, developed by Ambuel and colleagues to measure the pain and stress levels of children aged 0-18, was later adapted by Monique and colleagues in 2007 for premature infants aged ≥28 and ≤37 weeks. The PBCS evaluates 7 parameters such as Alertness, Calmness/Agitation, Respiratory Status (only with mechanical ventilation support) or Crying (not evaluated because it was scored only in children with spontaneous breathing), Physical Movement, Muscle Tone, Facial Movements and Average Heart Rate. Each item is a 5-point Likert type, scored from 1 to 5 from bad to good. According to the PBCS, the baby's comfort is evaluated based on the total score. Accordingly, 35 indicates the lowest and 7 the highest comfort score. A high score obtained from the scale indicates a low comfort level (Küçük Alemdar and Güdücü Tüfekçi, 2015). The validity and reliability study of the scale was conducted by Alemdar and Tüfekçi in 2015 and the Cronbach Alpha value was 0.88.

Time frame
6 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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