🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Turkey / NCT07681934
Active, not recruiting Not applicable

The Effect of Breast Milk Odor and Swaddling on Physiological Parameters and Stress Levels in Premature Infants Receiving Ventilator Support

NCT07681934 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-06-28
Last updated
2026-07-02

Condition(s) studied

Prematurity, Mechanical Ventilation

Investigational drug(s) / intervention(s)

Breast Milk SmellArsonControl

Breast Milk Smell: During the application, pre-test data and physiological measurement values, stress scale, and comfort scale levels are recorded three times, at the 5th and 20th minutes.

Arson: In order to prevent the possibility of the wrapping increasing the body temperature, the incubator temperature, which is kept at a standard level, will be reduced by 1oC during the intervention. Pre-test data and physiological measurement values, stress scale and comfort scale levels will be recorded three times during the application, at the 5th and 20th minutes.

Control: No intervention other than routine care will be applied to the control group of the study.

Study summary

It will be done to shorten the hospital stay of the newborn and increase the quality of care by proving the positive effect of the safe wrapping method and the smell of breast milk on the physiological parameters and stress level of the newborn in premature newborns receiving mechanical ventilator support.

1. Safe wrapping method positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
2. Safe wrapping method reduces stress in premature newborns receiving mechanical ventilation support.
3. Safe wrapping method increases comfort in premature newborns receiving mechanical ventilation support.
4. The smell of breast milk positively affects physiological parameters in premature newborns receiving mechanical ventilation support.
5. The smell of breast milk reduces stress in premature newborns receiving mechanical ventilation support.
6. The smell of breast milk increases comfort in premature newborns receiving mechanical ventilation support.

This study aims to answer the hypotheses

Eligibility

Sex
ALL
Min age
34 Weeks
Max age
36 Weeks
Healthy volunteers
No
Inclusion Criteria: * Newborns with gestational weeks between 340/7-366/7, * In the first 28 days of life, * High-flow nasal cannula applied, * Birth weight 1500 gr and above, * Breastfeeding mothers, * No health problems that would prevent positioning, Exclusion Criteria: * Those who have had a painful procedure within the last hour, * Those who have taken analgesic/sedative drugs within the last 6 hours, * Those who have undergone any surgical intervention, * Those with other diagnoses (hyperbilirubinemia, hypoglycemia, etc.), * Those with cerebral hypoxia/ischemia, * Those with intraventricular hemorrhage, * Newborns with congenital anomalies

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
KTO Karatay University Konya Karatay

More KTO Karatay University trials in Turkey

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07681934 on ClinicalTrials.gov ↗ ← All trials in Turkey