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

The Effect of the Safe Swaddling Method and the Scent of Breast Milk on Physiological Parameters, Stress, and Comfort Levels in Premature Newborns Receiving Mechanical Ventilator Support: A Randomized Controlled Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Prematurity, Mechanical Ventilation
• Intervention / Treatment: Other: Breast Milk Smell; Other: Arson; Other: Control

Detailed Description

The universe of the study will consist of premature newborns receiving ventilator support in the neonatal intensive care clinic of Selçuk University Medical Faculty Hospital. Three groups will be included in the study: the wrapping group (24), the breastfeeding group (24), and a control group (24). The study data will be collected using the Introductory Information Form, Preterm Infant Physiological Measurement Form, Premature Infant Comfort Scale, and the Neonatal Stress Scale. Before randomization, general information about the study will be given to the parents of newborns who meet the inclusion criteria, the mothers' consent will be obtained, and pre-test data will be collected. Premature newborns receiving ventilator support, whose pre-test data have been collected, will be assigned to the intervention and control groups using the simple randomization method. The intervention will be applied one hour after the 18:00 care, 10 minutes before the procedure, considering the calmest and most stable hours of the research unit, and will be evaluated at the fifth and twentieth minutes after the procedure.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Karatay
    • Konya, Karatay, Turkey (Türkiye), 42040
      • KTO Karatay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breast Milk Smell Group; The premature newborn's own mother's milk will be dripped 10 drops onto a sterile gauze in a container one millimeter away from the newborn's nose, and the breast milk in the container will be placed in the incubator where the new baby is to be milked.	Other: 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.
Experimental: Arson Group; A 90 cm² square muslin blanket will be used for wrapping. During the application, care will be taken to leave a certain space between the blanket and the newborn in order not to restrict the newborn's movements and to leave a suitable area where the newborn's feet can be comfortable when folding the bottom of the blanket.	Other: 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.
Experimental: Control Group; The control group of the study will not receive any intervention other than routine care.	Other: Control; No intervention other than routine care will be applied to the control group of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Premature Baby Comfort Scale	The scale was first developed by Ambuel et al. (1992) to assess the pain and stress levels of children aged 0-18 years hospitalized in a pediatric intensive care unit to determine the comfort levels of premature infants. It was later adapted by Caljouw et al. (2007) for premature infants aged 28-37 weeks. The scale is a 5-point Likert-type scale with seven subscales and 35 items. The subscales are defined as alertness, calmness/agitation, respiratory status or crying, physical movement, muscle tone, facial movements, and mean heart rate. The scale is a multidimensional measure that holistically assesses behavioral and physiological indicators of comfort in premature infants. As the total score on the scale increases, the infant's comfort level decreases; a score of 7 indicates the highest level of comfort, and a score of 35 indicates the lowest.	9 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newborn Stress Scale	Developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants, the scale consists of 24 items and 8 subscales: facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture. Each item is scored on a 3-point Likert-type scale from 0 to 2. The total score ranges from 0 to 16, with higher scores indicating higher stress levels.	9 Months

Collaborators and Investigators

• Sponsor: KTO Karatay University
• Investigators: Principal Investigator: Hediye Karakoç, KTO Karatay Üniversitesi

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Actual): August 30, 2025
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: August 19, 2025
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Respiratory Distress; Physiological Parameters; Swaddling; Premature Infant; Neonatal Comfort; Neonatal Stress; Breast Milk Scent
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Premature Birth; Dyspnea
• Other Study ID Numbers: KARATAYU-SBF-ES-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Security

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No