Swaddling and Facilitated Tucking During Nasal CPAP Application

NCT07077148 | Not Yet Recruiting

• 1 other identifier: Gamze ALTAY
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Disease of A Newborn

Keywords

facilitated tucking; Nasal cpap; swaddling; pain; comfort; stress

Outcome Measures

Primary Outcomes (2)

• 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).

  6 month

• 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.

  6 month

Study Arms (3)

Facilitated tucking group

EXPERIMENTAL

Newborns in this group will be placed in the facilitated tucking position during nasal CPAP application.

Behavioral: Facilitated tucking

Swaddling group

EXPERIMENTAL

Newborns in this group will be swaddled during nasal CPAP application.

Behavioral: Swaddling

Control group

NO INTERVENTION

newborns in this group will receive standard care.

Interventions

Facilitated tucking BEHAVIORAL

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

Facilitated tucking group

Swaddling BEHAVIORAL

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

Swaddling group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Those without mental or neurological problems.

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdogan University

Rize, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Facilitated Tucking

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Gamzegül ALTAY, PhD

CONTACT

+905456119296; gamzegulaltay25@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Child Health and Disease Nursing

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 22, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)