The Effects Of Safe Swadding On Newborns' Oxygen Saturation And Comfort Level

NCT06900127 | Completed DMC

• 1 other identifier: Safe Swaddling
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: This study was conducted as a randomized controlled experimental study to determine the effects of safe swaddling on oxygen saturation and comfort in preterm newborns born between 30-36 weeks of gestation. Methods: The sample of the study consisted of 70 newborns (Safe swaddling group =35, control group=35) hospitalized in the neonatal intensive care unit of a university hospital in Türkiye. The preterm newborns in the safe swaddling group were monitored by applying the safe swaddling method outside of care hours (12:00, 18:00, 24:00, 06:00), while those in the control group were followed in accordance with the hospital routines. An information form and a newborn comfort behavior scale were used as data collection tools. Descriptive statistics, chi-square, t test, Anova, analysis of variance in repeated measures, and Tukey forward analysis were used to evaluate the data.

Conditions

Newborn; Fit; Safety Issues

Keywords

Safe Swaddling; Comfort; Saturation; Newborn

Outcome Measures

Primary Outcomes (2)

• comfort

  comfort score averages

  once a day until discharged (up to 60 days) Min.=6 points, Max.=30 points

• oxygen saturation

  daily oxygen saturation averages

  every day until discharge (up to 60 days)

Secondary Outcomes (2)

• NCPAP

  every day until discharge (up to 60 days)

• hospitalization

  every day until discharge (up to 60 days)

Study Arms (2)

Safe Swaddling

EXPERIMENTAL

Behavioral: Safe Swaddling

control group

NO INTERVENTION

Interventions

Safe Swaddling BEHAVIORAL

newborns will be wrapped with the safe wrapping method.

Safe Swaddling

Eligibility Criteria

• Age: 1 Day - 60 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The baby's gestational age to be between 30 weeks and 36 weeks,
• The baby's birth weight to be 1250 grams or more,
• The baby's oxygen requirement to be 40% or less,
• The baby's to be between 4-28 days old,
• The swaddling to be done by the same nurse,
• Parents must agree to participate in the study.

You may not qualify if:

• In our study, the babies were not followed up during the first 72 hours because of possible interventions such as giving them surfactant, exposing them to more invasive procedures, and taking heel blood resulting fluctuations in their vital signs.
• The baby's having any kind of congenital anomalies.
• There being a situation that prevents swaddling.
• Criteria for dropping from the study while the study is ongoing
• When the baby loses his/her life,
• When the family gives up participating in the study,
• When the baby is intubated.

Sponsors & Collaborators

• Ayse Sonay Turkmen, Prof.Dr: lead

Study Sites (2)

Ayşe Sonay Türkmen

Karaman, 70100, Turkey (Türkiye)

Location

Karamanoglu Mehmetbey University

Karaman, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 28, 2025
• Study Start: March 14, 2024
• Primary Completion: August 15, 2024
• Study Completion: March 1, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

TU (2)