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

NCT07681934 | Active Not Recruiting

• 1 other identifier: KARATAYU-SBF-ES-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Prematurity, Mechanical Ventilation

Keywords

Breast Milk Scent; Swaddling; Premature Infant; Mechanical Ventilation; Physiological Parameters; Neonatal Stress; Neonatal Comfort; Respiratory Distress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Newborn Stress Scale

  9 Months

Study Arms (3)

Breast Milk Smell Group

EXPERIMENTAL

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

Arson Group

EXPERIMENTAL

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

Control Group

EXPERIMENTAL

The control group of the study will not receive any intervention other than routine care.

Other: Control

Interventions

Breast Milk Smell OTHER

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.

Breast Milk Smell Group

Arson OTHER

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.

Arson Group

Control OTHER

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

Control Group

Eligibility Criteria

• Age: 34 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Konya, Karatay, 42040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Dyspnea

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hediye Karakoç

  KTO Karatay Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: July 2, 2026
• Study Start: June 28, 2024
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 2, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)